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Cochrane Library Cochrane Database of Systematic Reviews Interventions for preventing postpartum constipation (Review) Cochrane Database of Systematic Reviews

October 2022
Cochrane Database of Systematic Reviews

DOI:10.1002/14651858.CD011625.pub3.

Authors:

Eunice Turawa

South African Medical Research Council

Alfred Musekiwa

University of Pretoria

Anke Rohwer

Stellenbosch University

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Interventions for preventing postpartum constipation (Review) 

Turawa EB, Musekiwa A, Rohwer AC 

TurawaEB, MusekiwaA, RohwerAC.

Interventions for preventing postpartum constipation.

Cochrane Database of Systematic Reviews 2020, Issue 8. Art. No.: CD011625.

DOI: 10.1002/14651858.CD011625.pub3.

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Interventions for preventing postpartum constipation (Review)

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T A B L E  O F  C O N T E N T S

HEADER......................................................................................................................................................................................................... 1

ABSTRACT..................................................................................................................................................................................................... 1

PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2

SUMMARY OF FINDINGS.............................................................................................................................................................................. 4

BACKGROUND.............................................................................................................................................................................................. 8

OBJECTIVES.................................................................................................................................................................................................. 9

METHODS..................................................................................................................................................................................................... 9

RESULTS........................................................................................................................................................................................................ 13

Figure 1.................................................................................................................................................................................................. 14

Figure 2.................................................................................................................................................................................................. 16

Figure 3.................................................................................................................................................................................................. 17

DISCUSSION.................................................................................................................................................................................................. 21

AUTHORS' CONCLUSIONS........................................................................................................................................................................... 22

ACKNOWLEDGEMENTS................................................................................................................................................................................ 23

REFERENCES................................................................................................................................................................................................ 24

CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 27

DATA AND ANALYSES.................................................................................................................................................................................... 35

Analysis 1.1. Comparison 1: Laxative versus placebo, Outcome 1: Number of women with first bowel movement within 24 hours

aer delivery.........................................................................................................................................................................................

Analysis 1.2. Comparison 1: Laxative versus placebo, Outcome 2: Number of women with first bowel movement on day 1 aer

delivery..................................................................................................................................................................................................

Analysis 1.3. Comparison 1: Laxative versus placebo, Outcome 3: Number of women with first bowel movement on day 2 aer

Analysis 1.4. Comparison 1: Laxative versus placebo, Outcome 4: Number of women with first bowel movement on day 3 aer

Analysis 1.5. Comparison 1: Laxative versus placebo, Outcome 5: Number of women with first bowel movement on day 4 aer

Analysis 1.6. Comparison 1: Laxative versus placebo, Outcome 6: Stool consistency - loose or watery stools............................... 38

Analysis 1.7. Comparison 1: Laxative versus placebo, Outcome 7: Number of postpartum enemas given..................................... 38

Analysis 1.8. Comparison 1: Laxative versus placebo, Outcome 8: Number of women receiving suppositories or enemas........... 39

Analysis 1.9. Comparison 1: Laxative versus placebo, Outcome 9: Number of women having 2 or more bowel movements per

day..........................................................................................................................................................................................................

Analysis 1.10. Comparison 1: Laxative versus placebo, Outcome 10: Number of days on which a bowel movement occurred...... 40

Analysis 1.11. Comparison 1: Laxative versus placebo, Outcome 11: Adverse eects: women with abdominal cramps................ 41

Analysis 1.12. Comparison 1: Laxative versus placebo, Outcome 12: Adverse eects on the baby................................................. 41

Analysis 2.1. Comparison 2: Laxative plus bulking agent versus laxative alone, Outcome 1: Faecal incontinence during first 10

postpartum days...................................................................................................................................................................................

APPENDICES................................................................................................................................................................................................. 42

WHAT'S NEW................................................................................................................................................................................................. 43

HISTORY........................................................................................................................................................................................................ 43

CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 43

DECLARATIONS OF INTEREST..................................................................................................................................................................... 44

SOURCES OF SUPPORT............................................................................................................................................................................... 44

DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 44

INDEX TERMS............................................................................................................................................................................................... 44

Interventions for preventing postpartum constipation (Review)

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[Intervention Review]

Interventions for preventing postpartum constipation

Eunice B Turawa1,2, Alfred Musekiwa3, Anke C Rohwer4

1Division of Health Systems and Public Health, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch

University, Cape Town, South Africa. 2South African Medical Research Council, Burden of Disease Research Unit, Cape Town, South

Africa. 3Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Faculty of Medicine and Health Sciences,

Stellenbosch University, Cape Town, South Africa. 4Centre for Evidence-based Health Care, Faculty of Medicine and Health Sciences,

Stellenbosch University, Cape Town, South Africa

Contact address: Eunice B Turawa, kbolanle@gmail.com, Eunice.Turawa@mrc.ac.za.

Editorial group: Cochrane Pregnancy and Childbirth Group.

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 8, 2020.

Citation: TurawaEB, MusekiwaA, RohwerAC. Interventions for preventing postpartum constipation. Cochrane Database of Systematic

Reviews 2020, Issue 8. Art. No.: CD011625. DOI: 10.1002/14651858.CD011625.pub3.

A B S T R A C T

Background

Postpartum constipation, with symptoms, such as pain or discomfort, straining, and hard stool, is a common condition aecting mothers.

Haemorrhoids, pain at the episiotomy site, eects of pregnancy hormones, and haematinics used in pregnancy can increase the risk of

postpartum constipation. Eating a high-fibre diet and increasing fluid intake are usually encouraged. Although laxatives are commonly

used in relieving constipation, the eectiveness and safety of available interventions for preventing postpartum constipation should be

ascertained. This is an update of a review first published in 2015.

Objectives

To evaluate the eectiveness and safety of interventions for preventing postpartum constipation.

Search methods

We searched Cochrane Pregnancy and Childbirth’s Trials Register, and two trials registers ClinicalTrials.gov, the WHO International Clinical

Trials Registry Platform (ICTRP) (7 October 2019), and screened reference lists of retrieved trials.

Selection criteria

We considered all randomised controlled trials (RCTs) comparing any intervention for preventing postpartum constipation versus another

intervention, placebo, or no intervention in postpartum women. Interventions could include pharmacological (e.g. laxatives) and non-

pharmacological interventions (e.g. acupuncture, educational and behavioural interventions). Quasi-randomised trials and cluster-RCTs

were eligible for inclusion; none were identified. Trials using a cross-over design were not eligible.

Data collection and analysis

Two review authors independently screened the results of the search to select potentially relevant trials, extracted data, assessed risk of

bias, and the certainty of the evidence, using the GRADE approach. We did not pool results in a meta-analysis, but reported them per study.

Main results

We included five trials (1208 postpartum mothers); three RCTs and two quasi-RCTs. Four trials compared a laxative with placebo; one

compared a laxative plus a bulking agent versus the same laxative alone, in women who underwent surgical repair of third degree perineal

tears. Trials were poorly reported, and four of the five trials were published over 40 years ago. We judged the risk of bias to be unclear for

most domains. Overall, we found a high risk of selection and attrition bias.

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Laxative versus placebo

We included four trials in this comparison. Two of the trials examined the eects of laxatives that are no longer used; one has been found

to have carcinogenic properties (Danthron), and the other is not recommended for lactating women (Bisoxatin acetate); therefore, we did

not include their results in our main findings.

None of the trials included in this comparison assessed our primary outcomes: pain or straining on defecation, incidence of postpartum

constipation, or quality of life; or many of our secondary outcomes.

A laxative (senna) may increase the number of women having their first bowel movement within 24 hours aer delivery (risk ratio (RR) 2.90,

95% confidence interval (CI) 2.24 to 3.75; 1 trial, 471 women; low-certainty evidence); may have little or no eect on the number of women

having their first bowel movement on day one aer delivery (RR 0.94, 95% CI 0.72 to 1.22; 1 trial, 471 women; very low-certainty evidence);

may reduce the number of women having their first bowel movement on day two (RR 0.23, 95% CI 0.11 to 0.45; 1 trial, 471 women; low-

certainty evidence); and day three (RR 0.05, 95% CI 0.00 to 0.89; 1 trial, 471 women; low-certainty evidence); and may have little or no eect

on the number of women having their first bowel movement on day four aer delivery (RR 0.22, 95% CI 0.03 to 1.87; 1 trial, 471 women;

very low-certainty evidence), but some of the evidence is very uncertain.

Adverse eects were poorly reported. Low-certainty evidence suggests that the laxative (senna) may increase the number of women

experiencing abdominal cramps (RR 4.23, 95% CI 1.75 to 10.19; 1 trial, 471 women). Very low-certainty evidence suggests that laxatives

taken by the mother may have little or no eect on loose stools in the baby (RR 0.62, 95% CI 0.16 to 2.41; 1 trial, 281 babies); or diarrhoea

(RR 2.46, 95% CI 0.23 to 26.82; 1 trial, 281 babies).

Laxative plus bulking agent versus laxative only

Very low-certainty evidence from one trial (147 women) suggests no evidence of a dierence between these two groups of women who

underwent surgical repair of third degree perineal tears; only median and range data were reported. The trial also reported no evidence

of a dierence in the incidence of postpartum constipation (data not reported), but did not report on quality of life. Time to first bowel

movement was reported as a median (range); very low-certainty evidence suggests little or no dierence between the two groups. A laxative

plus bulking agent may increase the number of women having any episode of faecal incontinence during the first 10 days postpartum (RR

1.81, 95% CI 1.01 to 3.23; 1 trial, 147 women; very low-certainty evidence). The trial did not report on adverse eects of the intervention

on babies, or many of our secondary outcomes.

Authors' conclusions

There is insuicient evidence to make general conclusions about the eectiveness and safety of laxatives for preventing postpartum

constipation. The evidence in this review was assessed as low to very low-certainty evidence, with downgrading decisions based on

limitations in study design, indirectness and imprecision.

We did not identify any trials assessing educational or behavioural interventions. We identified four trials that examined laxatives versus

placebo, and one that examined laxatives versus laxatives plus stool bulking agents.

Further, rigorous trials are needed to assess the eectiveness and safety of laxatives during the postpartum period for preventing

constipation. Trials should assess educational and behavioural interventions, and positions that enhance defecation. They should report

on the primary outcomes from this review: pain or straining on defecation, incidence of postpartum constipation, quality of life, time to

first bowel movement aer delivery, and adverse eects caused by the intervention, such as: nausea or vomiting, pain, and flatus.

P L A I N  L A N G U A G E  S U M M A R Y

Interventions for preventing constipation aer giving birth

What is the issue?

Constipation during the postpartum period is a bowel disorder, characterised by symptoms, such as pain or discomfort, straining, hard

lumpy stool, and a sense of incomplete bowel evacuation. Administration of enemas before labour, the ability of women to eat during active

labour, and irregular and altered eating habits during the first few days aer delivery can each have an influence on bowel movements in

the days aer giving birth. This is an update of a review first published in 2015.

Why is this important?

Pain and discomfort during defecation can be a source of concern to the new mother, who is recuperating from the stress of delivery,

particularly if she has had perineal tears repaired, or has developed haemorrhoids. Postpartum constipation can be stressful because of

undue pressure on the rectal wall, leading to restlessness and painful defecation, which may aect the quality of life of the mother and

the newborn.

What evidence did we find?

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We searched for trials to 7 October 2019. We found no new trials that met our inclusion criteria, thus, we included the initial five trials

(involving a total of 1208 women) in this update. Overall, the trials were poorly reported, and four out of five trials were published more

than 40 years ago. Four trials compared a laxative with a placebo.

Two trials assessed the eects of laxatives that we now find might be harmful for breastfeeding mothers. One drug, Danthron, has been

shown to cause cancer in animals, and the other, Bisoxatin acetate, is no longer recommended when breastfeeding. Therefore, we did not

include the results of these trials in our main findings.

The trials did not look at pain or straining on defecation, incidence of constipation, or quality of life, but did assess the time to first bowel

movement. In one study assessing the eects of senna, compared to the placebo group, more women in the laxative group had a bowel

movement on the day of delivery, and fewer women had their first bowel movement on days 2 and 3, while the results were inconclusive

between groups on days 1 and 4 aer delivery. More women had abdominal cramps compared to the women in the placebo group, and

babies whose mothers received the laxative were no more likely to experience loose stool or diarrhoea. The evidence for all these outcomes

is largely uncertain, as we have very serious concerns about risk of bias, and the results are all based on one small study that was conducted

at a single institution in South Africa.

One trial compared a laxative plus a stool-bulking agent (Ispaghula husk) to a laxative only for women who underwent surgery to repair a

third degree tear of the perineum (involving the internal or external anal sphincter muscles) that occurred during vaginal delivery. The trial

reported on pain or straining on defecation, but did not find a clear dierence in the pain score between groups. The trial reported that

women who were given laxative plus a stool-bulking agent were more likely to experience fecal incontinence in the immediate postpartum

period. However, the evidence is very uncertain. The trial did not report on any adverse eects on the baby.

What does this mean?

There is not enough evidence from randomised controlled trials on the eectiveness and safety of laxatives during the early postpartum

period to make general conclusions about their use to prevent constipation.

We did not identify any trials assessing educational or behavioural interventions, such as a high-fibre diet and exercise. We need large,

high-quality trials on this topic, specifically on non-medical interventions to prevent postpartum constipation, such as advice on diet and

physical activity.

Interventions for preventing postpartum constipation (Review)

S U M M A R Y  O F  F I N D I N G S



Summary of findings 1.  Laxative compared to placebo for preventing postpartum constipation

Laxative compared to placebo for preventing postpartum constipation

Patient or population: women in the postpartum period

Setting: hospital setting in South Africa and the USA

Intervention: laxative

Comparison: placebo

Anticipated absolute effects*

(95% CI)

Outcomes

Risk with

placebo

Risk with laxa-

tive

Relative effect

(95% CI)

№ of partici-

pants

(studies)

Certainty of

the evidence

(GRADE)

Comments

Pain or straining on defe-

cation

- - - - - not reported

Incidence of postpartum

constipation

- - - - - not reported

Quality of life - - - - - not reported

Study populationTime to first bowel

movement (BM)

(№ women with 1st BM less

than 24 hours after deliv-

ery)

219 per 1000 634 per 1000

(490 to 820)

RR 2.90

(2.24 to 3.75)

471

(1 RCT)

⊕⊕⊝⊝

LOWa



Study populationTime to first BM

(№ women with 1st BM on

day 1 after delivery) 328 per 1000 308 per 1000

(236 to 400)

RR 0.94

(0.72 to 1.22)

471

(1 RCT)

⊕⊝⊝⊝

VERY LOWa,b,c

Two other studies measured this outcome

but they were not pooled in a meta-analysis.

These studies investigated Danthron (a lax-

ative that is no longer marketed due to car-

cinogenic properties), and bisoxatin acetate

(a laxative that is not recommended for use

when breastfeeding).

Study populationTime to first BM

(№ women with 1st BM on

day 2 after delivery) 178 per 1000 41 per 1000

(20 to 80)

RR 0.23

(0.11 to 0.45)

471

(1 RCT)

⊕⊕⊝⊝

LOWa

Two other studies measured this outcome

but they were not pooled in a meta-analysis.

These studies investigated Danthron (a lax-

ative that is no longer marketed due to car-

cinogenic properties), and bisoxatin acetate

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(a laxative that is not recommended for use

when breastfeeding).

Study populationTime to first BM

(№ women with 1st BM on

day 3 after delivery) 40 per 1000 2 per 1000

(0 to 36)

RR 0.05

(0.00 to 0.89)

471

(1 RCT)

⊕⊕⊝⊝

LOWa

One other study measured this outcome but

it was not included in a meta-analysis be-

cause it investigated Danthron (a laxative

that is no longer marketed due to carcino-

genic properties).

Study populationTime to first BM

(№ women with 1st BM on

day 4 after delivery) 20 per 1000 4 per 1000

(1 to 38)

RR 0.22

(0.03 to 1.87)

471

(1 RCT)

⊕⊝⊝⊝

VERY LOWa,b,c

One other study measured this outcome but

it was not included in a meta-analysis be-

cause it investigated Danthron (a laxative

that is no longer marketed due to carcino-

genic properties).

Study populationAdverse effects on

women: abdominal

cramps 24 per 1000 103 per 1000

(43 to 248)

RR 4.23

(1.75 to 10.19)

471

(1 RCT)

⊕⊕⊝⊝

LOWa



Study populationAdverse effects on ba-

bies: loose stools

39 per 1000 24 per 1000

(6 to 93)

RR 0.62

(0.16 to 2.41)

281

(1 RCT)

⊕⊝⊝⊝

VERY LOWa,b,c



Study populationAdverse effects on ba-

bies: diarrhoea

6 per 1000 16 per 1000

(1 to 173)

RR 2.46

(0.23 to 26.82)

281

(1 RCT)

⊕⊝⊝⊝

VERY LOWa,b,c



*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and

its 95% CI).

CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence

High certainty. We are very confident that the true effect lies close to that of the estimate of the effect

Moderate certainty. We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is

substantially different

Low certainty. Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect

Very low certainty. We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect

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aDowngraded by 2 levels due to very serious study limitations (high risk of attrition bias, selection bias (quasi-randomised studies) or concern due to industry sponsorship and

statistical analysis

bDowngraded by 1 level due to imprecision: wide confidence intervals that are consistent with possible benefit and possible harm

cDowngraded by 2 levels due to imprecision: few participants, few events and wide confidence intervals that are consistent with possible benefit and possible harm.

Note: We did not include in the analysis studies that assessed the eects of Danthron and Bisoxatin acetate, as the former has been shown to be carcinogenic in animals (National

Toxicology Program 2016) and is no longer marketed, and the latter is no longer recommend in breastfeeding women (Omega Pharma 2016)



Summary of findings 2.  Laxative plus bulking agent compared to laxative alone for preventing postpartum constipation

Laxative plus bulking agent compared to laxative alone for preventing postpartum constipation

Patient or population: postpartum women who underwent surgical repair of third degree perineal tears

Setting: hospital setting in high-income countries

Intervention: laxative plus bulking agent

Comparison: laxative alone

Anticipated absolute effects*

(95% CI)

Outcomes

Risk with laxa-

tive alone

Risk with laxa-

tive plus bulk-

ing agent

Relative effect

(95% CI)

№ of partici-

pants

(studies)

Certainty of

the evidence

(GRADE)

Comments

Pain or straining on defecation

(Likert-scale from 1 to 5; 1 = no pain; 5 = worst

pain)

  No difference between

groups (P = 0.11)

147

(1 study)

⊕⊝⊝⊝

VERY LOWa,b,c

reported in pa-

per

Incidence of postpartum constipation - - - - - not reported

Quality of life - - - - - not reported

Time to first bowel movement   No difference between

groups (P = 0.34)

147

(1 study)

⊕⊝⊝⊝

VERY LOWa,b,c

reported in pa-

per

Study populationAdverse effects on women: faecal inconti-

nence during first 10 postpartum days

182 per 1000 329 per 1000

(184 to 587)

RR 1.81

(1.01 to 3.23)

147

(1 study)

⊕⊝⊝⊝

VERY LOWa,b,c



Adverse effects on babies - - - - - not reported

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*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and

its 95% CI).

CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence

High certainty: We are very confident that the true effect lies close to that of the estimate of the effect

Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is

substantially different

Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect

Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

aDowngraded by 1 level due to study limitations: high risk of attrition bias and unclear risk of selection, performance, and detection bias

bDowngraded by 1 level due to imprecision: small sample size, wide confidence intervals that are consistent with possible benefit and possible harm

cDowngraded by 1 level due to indirectness: participants are women undergoing surgical repair of third degree perineal tears, results based on a single study from a single

institution in Ireland

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B A C K G R O U N D

The postpartum period, also referred to as postnatal or

puerperium, is the critical transitional period following the

expulsion of the placenta, and extends to the next six weeks

following childbirth, during which the mother's body, the

pregnancy hormone levels, and the size of the uterus return to

their non-pregnant state (Liu 2009; WHO 2010). The physiological

changes during this period can be similar, but, the eects and

the experience of these changes, the duration and severity,

together with how it is experienced, vary greatly from person to

person, and may lead to serious adverse consequences, including

physiological and psychological ill-health, low self-esteem, and

poor quality of life for the mother (de Groot 2018; Zainur 2006). It

is therefore important that adequate attention, appropriate advice

and suicient services and care be made available to the new

mothers during this period in order to prevent postpartum health

problems, identify complications at an early stage and provide

adequate assistance (WHO 1998).

The postpartum period can be divided into three phases: the

acute postpartum phase, the subacute postpartum phase, and

the delayed postpartum phase. The acute phase is the immediate

six to 12 hours aer delivery and expulsion of the placenta, the

subacute postpartum phase extends from two to six weeks aer

delivery, and the delayed postpartum phase commences aer the

subacute postpartum period and lasts up to six months (Romano

2010). It is the time when abdominal and pelvic muscles and the

connective tissues and ligaments returns to the pre-pregnancy

state. However, recovery from birth injuries and complications,

such as pelvic prolapse and dyspareunia (painful intercourse), are

usually very slow during this period, and in some cases, total

recovery may not be achieved. It was estimated that about 87%

to 94% of women suer from at least one health complication

in the acute postpartum phase, while 31% complained of health

problems during the delayed postpartum phase (Borders 2006).

Description of the condition

Constipation is a bowel disorder, characterised by infrequent (fewer

than three bowel movements a week in adults), hard, dry, or

lumpy stools that are diicult or painful to pass, or a feeling of

incomplete evacuation, anorectal obstruction, or need for manual

manoeuvres (Higgins 2004). The diagnosis of constipation is both

subjective and objective. According to the Rome IV diagnostic

criteria, a diagnosis of functional constipation should include two

of the following criteria, which must be met over the last three

months, with symptom onset at least six months prior to diagnosis:

straining during at least 25% of defecations, lumpy or hard stools

for at least 25% of defecations, sensation of incomplete evacuation

for at least 25% of defecations, sensation of anorectal obstruction

or blockage for at least 25% of defecations, manual manoeuvres

to facilitate at least 25% of defecations (e.g. digital evacuation,

support of the pelvic floor), fewer than three spontaneous bowel

movement per week; loose stools are rarely present without the

use of laxatives, and there are insuicient criteria for irritable bowel

syndrome (Drossman 2016; Appendix 1).

The Bristol Stool Form Scale (BSFS) is a formal research tool used to

assess stool consistency and intestinal transit rate. It is an ordinal

scale used to rate and categorise stool into seven classifications,

according to stool consistency (Appendix 2). It is also useful in

evaluating the eectiveness of an intervention for gastrointestinal

tract disease and clinical assessment. It helps people to report on

stool consistency adequately, thus proving a guide in the diagnosis

and treatment of gastrointestinal disorders (Lewis 1997). The BSFS

tool classifies stool into seven categories ranging from hard lumps

like nuts stool (type 1) to watery without solid pieces, entirely liquid

(type 7). Types 1 and 2 are indicative of constipation, Types 3 and

4 are considered normal stool consistency that is easy to defecate,

while Types 6 and 7 are considered abnormal consistency (Lewis

1997).

Functional constipation is common across the general population,

and is a source of concern during pregnancy and the postpartum

period. Worldwide, the prevalence of constipation in all ages lies

between 4.1% and 25.6%, in studies using self-reported measures

of constipation, and between 2.6% and 26.9% in those using

the Rome criteria (Schmidt 2014). The prevalence of self-reported

constipation among Turkiish women during the postpartum period

was estimated to be between 15.5% and 61.6% (Gozum 2005);

with a higher prevalence (41.1%) among multiparous women

(Aksu 2017). Kabakian-Khasholian 2014 reported that about

45.8% of women experienced constipation following delivery

and about 42.4% experienced back pain, which could contribute

to constipation in the postpartum period (Kabakian-Khasholian

2014). Recovery from birth trauma may extend up to six to

12 months or more in postpartum women (MacArthur 1991).

About 25.5% of women may experience persistent genito-pelvic

postpartum pain at three to 12 months aer delivery (Cappell 2017).

Similarly, an earlier study reported that about 94% of Australian

women complained of discomfort and pain from haemorrhoids

(24.6%) and perineal pain (21%) at six to seven months aer

childbirth, supporting the extension of the postpartum period, and

health issues related to childbirth (Brown 1998).

The causes of postpartum constipation are multifactorial.

Interruption in dietary intake during labour, and dehydration

caused from prolonged hours of labour without suicient fluid

intake may contribute to postpartum constipation. Also, the eect

of elevated progesterone levels during pregnancy, which may still

be in circulation during the first few weeks of postpartum, is

thought to be associated with postpartum constipation, due to its

eect on the smooth muscles. Similarly, the eect of analgesics and

opiates used in labour could lead to postpartum constipation. Pain

from a raw perineum, repaired episiotomy or perineal tear, or pain

from a caesarean section could make the new mother hesitate to

defecate when the urge arises. Other risk factors for postpartum

constipation include pain from haemorrhoids, damage to levator

ani muscles (pelvic floor muscle) and pelvic floor disorders, and

adverse eects of maternity drugs, such as magnesium sulphate,

used as a tocolytic to prevent preterm labour, or treat pre-

eclampsia. Maternal diet during the postpartum period, in terms of

inadequate consumption of fruits, vegetables, whole grain cereals,

and fibre also contributes to postpartum constipation. In Africa and

some Asian countries, the postpartum period is oen marked with

cultural practices and diet restrictions that play a remarkable role

in the onset of constipation during this critical and sensitive period.

In the Chinese culture, for example, the new mother must follow a

special diet, behaviour, and lifestyle that discourages consumption

of cold food, including a low fruit and vegetable intake, alongside

limited movement, behind closed doors and windows (Lin 2009).

Postpartum constipation not only causes discomfort to the new

mother, but it may also impact on her physical and social health

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status, and may hinder timely response to the needs of the newborn

(Cheng 2006). Postpartum constipation is associated with reduced

quality of life, and significant health risks that negatively aect the

duties of the new mother with respect to her baby, family, and social

roles, as well as her body image.

Description of the intervention

Interventions to prevent constipation include pharmacological and

non-pharmacological interventions such as dietary and lifestyle

modification. Lifestyle interventions refer to diet and physical

exercise, and are advocated during pregnancy and the postpartum

period. A diet high in fibre and adequate fluid intake may be all that

is required to prevent postpartum constipation (Zainur 2006).

In terms of pharmacological interventions, laxatives are the drugs

of choice in relieving symptoms of constipation, and can be

taken orally in either liquid, tablet, powder, or granule form.

Laxatives are grouped into categories according to their mode

of action: bulk forming laxatives, osmotic laxatives, stimulant

laxatives, faecal soeners, and lubricants (Candy 2011). Bulk

forming laxatives include bran and methylcellulose; osmotic

laxatives include magnesium hydroxide, sorbitol, lactulose, and

polyethylene glycol; stimulant laxatives include bisacodyl and

senna; and stool soeners include docusate sodium (Andrews

2011; Balch 2010; NIH-NIDDK 2018).

Alternative interventions for constipation also exist. Studies have

reported on the eicacy of acupuncture and Chinese herbal

medicine as interventions for the prevention of postpartum

constipation (Jia 2009; Lin 2009).

How the intervention might work

A good understanding of the causes of constipation can help to

prevent and avert problems that are associated with constipation.

Constipation occurs when the stool stays in the colon longer than

expected, and the colon absorbs too much water from the stool,

thus making the stool hard and dry, and therefore, diicult to pass

(NIH-NIDDK 2018). Interventions for preventing constipation in the

postpartum are not dierent from the typical clinical interventions

for constipation, however, the safety of these interventions during

the postpartum period is unclear. Bulk forming laxatives increase

the weight and water content, and facilitate peristaltic movement

of stools (Balch 2010). However, inadequate water intake with the

use of bulk forming laxative could increase bloating (Balch 2010).

Osmotic laxatives, help retain water in the colon, thereby soening

the stool and increasing the volume of the stools (NIH-NIDDK

2018). Stimulant laxatives directly stimulate the aerent nerves and

irritate the intestinal wall, thereby easing the bowel movement

(Andrews 2011). A stool soener soens the stool and enhances

easy defecation. Enemas provide a mechanical stimulation on the

walls of the rectum, thereby creating a sense of urgency to defecate.

Acupuncture and Chinese herbs reportedly work by correcting

the underlying malfunctions through strengthening the intestinal

tract and thereby improving peristalsis. The Yun-chang capsule,

a Chinese herb capsule, was found to be eective and safe for

the treatment of patients with functional constipation (Jia 2009),

while a systematic review reported an overall significant benefit of

traditional Chinese medicine in relieving constipation (Lin 2009).

Dietary and lifestyle interventions play an important role in

preventing postpartum constipation. High-fibre foods, such as

fruits and vegetables, can help to relieve symptoms and prevent

constipation during the postpartum period (Liu 2009). Fibre

is indigestible, adds bulk to the stool, and stimulates bowel

movements; it also improves digestion, and prevents constipation

by soening the stools (Balch 2010). Adequate fluid intake will

help soen the stool and ease the bowel movement, thus

preventing constipation during the postpartum period. Gradual

resumption of aerobic and muscle conditioning activities that

are medically safe should be encouraged at the appropriate time

for postpartum women. Moderate, appropriate physical exercise

during the postpartum period will increase muscle tone, and

improve the movement of the food through the colon (Davies 2003).

Aerobic exercise, such as brisk walking, increases the heart and

the respiratory rates, thereby stimulating the natural contractions

of the intestinal muscles, and improves peristaltic movement,

thereby aiding the bowel movement. This will not only improve the

quality of life, but also improve blood circulation, reduce the risk

of developing heart disease, obesity, and other lifestyle diseases

(Mottola 2002).It is also important to heed the urge to defecate

and allow suicient time in the bathroom without distraction,

maintaining the correct posture in a relaxed atmosphere, to provide

enough time to evacuate the rectum completely.

Why it is important to do this review

The postpartum period is a crucial time for the new mother,

newborn baby, and the entire family. A number of health problems

may occur during this period that may result in physical discomfort

and poor quality of life for the mother and the baby. According to

Peppas 2008, constipation has a significant, negative impact on the

quality of life, in terms of morbidity and cost of treatment. A number

of systematic reviews on interventions for constipation have been

published (Gordon 2012; Higgins 2004; Lee-Robichaud 2010; Mugie

2011; Peppas 2008). We also completed a Cochrane Review on

interventions for treating postpartum constipation (Turawa 2014).

We did not find any trials eligible for inclusion, but some of

the excluded trials assessed interventions for the prevention of

constipation. The first version of this review included five trials

(Turawa 2015b). We updated the review to inform World Health

Organization guidelines.

O B J E C T I V E S

To evaluate the eectiveness and safety of interventions for

preventing postpartum constipation.

M E T H O D S

Criteria for considering studies for this review

Types of studies

We included all randomised controlled trials (RCTs) comparing any

intervention for the prevention of postpartum constipation with

another intervention, placebo, or no intervention. We included

quasi-randomised controlled trials. Cluster-randomised trials were

eligible for inclusion, but we did not identify any. Cross-over

trials were not eligible for inclusion because the physiological

condition of women during the first month postpartum might not

be the same as at six months aer childbirth. Studies in abstract

form that reported on interventions for preventing constipation in

postpartum were eligible for inclusion.

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Types of participants

We included all postpartum women (up to six months post-

delivery) without symptoms of postpartum constipation using

prespecified criteria (Rome and Bristol Stool Form Scale) and self-

report. We included postpartum women with comorbidities, such

as sphincter injuries. We used the six months criterion because

constipation is a problem that may last longer than six weeks

following delivery, which is the usual postpartum period.

Types of interventions

Intervention

Any intervention for the prevention of postpartum constipation,

both pharmacological (e.g. laxatives) and non-pharmacological

interventions (e.g. acupuncture, educational and behavioural

interventions).

Control

Any other intervention for the prevention of postpartum

constipation, placebo, or no intervention.

We considered the following comparisons.

1. One intervention versus no intervention

2. One intervention versus placebo

3. Two dierent interventions compared

4. One intervention versus a combination of interventions

5. Combination of interventions versus no intervention

6. Combination of interventions versus placebo

7. Dierent combinations of interventions

Types of outcome measures

Primary outcomes

1. Pain or straining on defecation

2. Incidence of postpartum constipation, as per self-report and

other diagnostic criteria

3. Quality of life, as measured in included studies (using e.g.

maternal postpartum quality of life (MAPP-QOL) questionnaire)

4. Time to first bowel movement (days; outcome not prespecified

at the protocol stage - see Dierences between protocol and

review)

Secondary outcomes

1. Stool consistency using Bristol Stool Form Scale (Appendix 2)

2. Use of alternative products, laxative agents, enemas

3. Relief of abdominal pain or discomfort

4. Stool frequency

5. Adverse eects in women caused by the intervention, including:

a. pain

b. nausea and vomiting

c. diarrhoea, flatus, and faecal incontinence

6. Because some of these drugs can be excreted through the breast

milk, we assessed any adverse eects of the intervention on the

baby, e.g. diarrhoea, flatus

Search methods for identification of studies

The following methods section of this review is based on a standard

template used by the Cochrane Pregnancy and Childbirth Group.

Electronic searches

For this update, we searched Cochrane Pregnancy and Childbirth’s

Trials Register by contacting their Information Specialist (7 October

2019).

The Register is a database containing over 25,000 reports of

controlled trials in the field of pregnancy and childbirth. It

represents over 30 years of searching. For full current search

methods used to populate Pregnancy and Childbirth’s Trials

MEDLINE, Embase, and CINAHL; the list of handsearched journals

and conference proceedings, and the list of journals reviewed via

the current awareness service, please follow this link.

Briefly, Cochrane Pregnancy and Childbirth’s Trials Register is

maintained by their Information Specialist and contains trials

identified from:

1. monthly searches of the Cochrane Central Register of Controlled

Trials (CENTRAL);

2. weekly searches of MEDLINE Ovid;

3. weekly searches of Embase Ovid;

4. monthly searches of CINAHL EBSCO;

5. handsearches of 30 journals and the proceedings of major

conferences;

6. weekly current awareness alerts for a further 44 journals, plus

monthly BioMed Central email alerts.

Search results are screened by two people, and we review the full

text of all relevant trial reports identified through the searching

activities described above. Based on the intervention described,

we assign each trial report a number that corresponds to a specific

Pregnancy and Childbirth review topic (or topics), and then add it

to the Register. The Information Specialist searches the Register for

each review using this topic number, rather than keywords. This

results in a more specific search set that has been fully accounted

for in the relevant review sections (Included studies; Excluded

studies; Ongoing studies).

In addition, we searched ClinicalTrials.gov and the WHO

International Clinical Trials Registry Platform (ICTRP) for

unpublished, planned, and ongoing trial reports (7 October 2019)

using the search methods detailed in Appendix 3.

Searching other resources

We checked the reference list of retrieved studies for additional

studies, and contacted authors and experts in the field.

We did not apply any language or date restrictions.

Data collection and analysis

For methods used in the previous version of this review, see Turawa

2015b.

For this update, we planned to use the following methods to assess

the reports that were identified as a result of the updated search.

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The following methods section is based on a standard template

used by Cochrane Pregnancy and Childbirth.

Selection of studies

Two review authors (Eunice Turawa (ET) and Alfred Musekiwa

(AM)) independently assessed for inclusion all the potential studies

we identified from the searches. We resolved any disagreement

through discussion, or if required, we consulted the third review

author (Anke Rohwer (AR)).

We developed a PRISMA study flow chart to display the number of

records identified, included, and excluded from the review (Liberati

2009).

Data extraction and management

We designed a form to extract data. For eligible studies, two review

authors extracted the data using the agreed form. We resolved

discrepancies through discussion, or if required, we consulted the

third review author. Data were entered into Review Manager 5

soware and checked for accuracy (Review Manager 2014).

When information regarding any of the above was unclear, we

planned to contact authors of the original reports to provide further

details.

Assessment of risk of bias in included studies

Two review authors independently assessed risk of bias for each

study, using the criteria outlined in the Cochrane Handbook for

Systematic Reviews of Interventions (Higgins 2011). They resolved

any disagreement by discussion, or by involving a third assessor.

(1) Random sequence generation (checking for possible

selection bias)

For each included study, we described the method used to generate

the allocation sequence in suicient detail to allow an assessment

of whether it should produce comparable groups.

We assessed the method as:

•low risk of bias (any truly random process, e.g. random number

table; computer random number generator);

•high risk of bias (any non-random process, e.g. odd or even date

of birth; hospital or clinic record number);

•unclear risk of bias.

(2) Allocation concealment (checking for possible selection bias)

For each included study, we described the method used to conceal

allocation to interventions prior to assignment, and assessed

whether intervention allocation could have been foreseen in

advance of, or during recruitment, or changed aer assignment.

We assessed the methods as:

•low risk of bias (e.g. telephone or central randomisation;

consecutively numbered sealed opaque envelopes);

•high risk of bias (open random allocation; unsealed or non-

opaque envelopes, alternation; date of birth);

•unclear risk of bias.

(3.1) Blinding of participants and personnel (checking for

possible performance bias)

For each included study, we described the methods used, if any, to

blind study participants and personnel from knowledge of which

intervention a participant received. We considered that studies

were at low risk of bias if they were blinded, or if we judged that the

lack of blinding was unlikely to aect results. We assessed blinding

separately for dierent outcomes or classes of outcomes.

We assessed the methods as:

•low, high, or unclear risk of bias for participants;

•low, high, or unclear risk of bias for personnel.

(3.2) Blinding of outcome assessment (checking for possible

detection bias)

For each included study, we described the methods used, if any, to

blind outcome assessors from knowledge of which intervention a

participant received. We assessed blinding separately for dierent

outcomes or classes of outcomes.

We assessed methods used to blind outcome assessment as:

•low, high, or unclear risk of bias.

(4) Incomplete outcome data (checking for possible attrition

bias due to the amount, nature and handling of incomplete

outcome data)

For each included study, and for each outcome or class of

outcomes, we described the completeness of data, including

attrition and exclusions from the analysis. We stated whether

attrition and exclusions were reported, and the numbers included

in the analysis at each stage (compared with the total randomised

participants), reasons for attrition or exclusion where reported, and

whether missing data were balanced across groups, or were related

to outcomes. Where suicient information was reported, or could

be supplied by the trial authors, we planned to re-include missing

data in the analyses that we undertook.

We assessed methods as:

•low risk of bias (e.g. no missing outcome data; missing outcome

data balanced across groups);

•high risk of bias (e.g. numbers or reasons for missing

data imbalanced across groups; ‘as treated’ analysis done

with substantial departure of intervention received from that

assigned at randomisation);

•unclear risk of bias.

(5) Selective reporting (checking for reporting bias)

For each included study, we described how we investigated the

possibility of selective outcome reporting bias, and what we found.

We assessed the methods as:

•low risk of bias (where it was clear that all of the study’s

prespecified outcomes and all expected outcomes of interest to

the review were reported);

•high risk of bias (where not all the study’s prespecified outcomes

were reported; one or more reported primary outcomes

were not prespecified; outcomes of interest were reported

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incompletely, and so could not be used; study failed to include

results of a key outcome that would have been expected to have

been reported);

•unclear risk of bias.

(6) Other bias (checking for bias due to problems not covered by

(1) to (5) above)

For each included study, we described any important concerns we

had about other possible sources of bias.

(7) Overall risk of bias

We made explicit judgements about whether studies were at high

risk of bias, according to the criteria given in the Handbook (Higgins

2011). With reference to (1) to (6) above, we planned to assess

the likely magnitude and direction of the bias, and whether we

considered it was likely to impact on the findings. In future updates,

we will explore the impact of the level of bias through undertaking

sensitivity analyses - see Sensitivity analysis.

Certainty of evidence

For this update, we assessed the certainty of the evidence using the

GRADE approach, as outlined in the GRADE Handbook, in order to

assess the certainty of the body of evidence relating to the following

outcomes for the main comparisons (GRADE Handbook). We did

not include studies that assessed the eects of Danthron and

Bisoxatin acetate, as the former has been shown to be carcinogenic

in animals and is no longer marketed (National Toxicology Program

2016), and the latter is no longer recommended in breastfeeding

women (Omega Pharma 2016).

1. Pain or straining on defecation

2. Incidence of postpartum constipation, as per self-report and

other diagnostic criteria

3. Quality of life, as measured in included studies (using e.g.

maternal postpartum quality of life (MAPP-QOL) questionnaire)

4. Time to first bowel movement

5. Adverse eects of the intervention on the women

6. Adverse eect of the intervention on the babies

We used GRADEpro GDT to import data from Review Manager

5, in order to create a 'Summary of findings’ table (GRADEpro

GDT; Review Manager 2014). We produced a summary of the

intervention eect and a measure of certainty for each of the

above outcomes using the GRADE approach. The GRADE approach

uses five considerations (study limitations, consistency of eect,

imprecision, indirectness, and publication bias) to assess the

quality of the body of evidence for each outcome. The evidence can

be downgraded from high quality by one level for serious (or by

two levels for very serious) limitations, depending on assessments

for risk of bias, indirectness of evidence, serious inconsistency,

imprecision of eect estimates, or potential publication bias.

Measures of treatment eect

Dichotomous data

For dichotomous data, we presented results as summary risk ratio

with 95% confidence intervals.

Continuous data

We had planned to calculate the mean dierence if outcomes were

measured in the same scale between trials, or standardised mean

dierence if trials measured the same outcome using dierent

scales. However, the included trials reported continuous outcomes

using medians and ranges, with corresponding P values, for

comparing treatment groups, and we reported them similarly.

Time-to-event data

For the outcome time to first bowel movement, we had planned

to calculate hazard ratios, however the data presented were only

the number of women experiencing the event aer less than 24

hours, one day, two days, three days, and four days; therefore, we

calculated risk ratios at each of the time points. The separate time

points were not prespecified, but were decided post hoc, according

to how data were reported by the trials.

Unit of analysis issues

There were no unit of analysis issues, as we only included

individually-randomised trials.

Cluster-randomised trials

We did not identify any cluster-randomised trials for this version

of the review. However, in future updates of this review, if we

identify any cluster-randomised trials, we will include them in the

analyses along with individually-randomised trials. We will adjust

their sample sizes using the methods described in the Handbook

for Systematic Reviews of Interventions Section 16.3.4, using an

estimate of the intra-cluster correlation co-eicient (ICC) derived

from the trial (if possible), from a similar trial, or from a study of a

similar population (Higgins 2011). If we use ICCs from other sources,

we will report this and conduct sensitivity analyses to investigate

the eect of variation in the ICC. If we identify both cluster-

randomised trials and individually-randomised trials, we plan to

synthesise the relevant information. We will consider it reasonable

to combine the results from both if there is little heterogeneity

between the study designs, and the interaction between the eect

of intervention and the choice of randomisation unit is considered

to be unlikely. We will also acknowledge heterogeneity in the

randomisation unit, and perform a subgroup analysis to investigate

the eects of the randomisation unit.

Other unit of analysis issues

In future studies, if a multi-arm study contributes multiple

comparisons to a particular meta-analysis, we will either combine

treatment groups, or split the ‘shared’ group as appropriate, and

take precautions to avoid the inclusion of data from the same

participant more than once in the same analysis.

Dealing with missing data

For included studies, we noted levels of attrition. In future updates,

if more eligible studies are included, we will explore the impact of

including studies with high levels of missing data (an imbalance

across each study arm of 10% or more) in the overall assessment of

treatment eect by using sensitivity analysis.

For all outcomes, we carried out analyses, as far as possible,

on an intention-to-treat basis, i.e. we attempted to include all

participants randomised to each group in the analyses. The

denominator for each outcome in each trial was the number

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randomised minus any participants whose outcomes were known

to be missing.

Assessment of heterogeneity

If we had carried out meta-analysis, we had planned to assess

statistical heterogeneity in each meta-analysis using the Tau,

I and Chi statistics. We would have regarded heterogeneity as

substantial if I was greater than 30%, and either Tau was greater

than zero, or there was a low P value (less than 0.10) in the Chi test

for heterogeneity. If we identified substantial heterogeneity (above

30%), we had planned to explore it by prespecified subgroup

analysis.

Assessment of reporting biases

In future updates, if there are 10 or more studies in the meta-

analysis, we will investigate reporting biases (such as publication

bias) using funnel plots. We will assess funnel plot asymmetry

visually. If asymmetry is suggested by a visual assessment, we will

perform exploratory analyses to investigate it.

Data synthesis

We carried out statistical analysis using Review Manager 5 soware

(Review Manager 2014). We did not perform meta-analysis in

this update of the review. However, if meta-analysis had been

possible, we had planned to use the following methods. We would

have used the fixed-eect model for combining data if it was

reasonable to assume that studies were estimating the same

underlying treatment eect, i.e. where trials were examining the

same intervention, and the trials’ populations and methods were

judged suiciently similar. Had there been clinical heterogeneity

suicient to expect that the underlying treatment eects diered

between trials, or if we had detected substantial statistical

heterogeneity, we would have used the random-eects model

to produce an overall summary, if an average treatment eect

across trials was considered clinically meaningful. We would have

treated the random-eects summary as the average range of

possible treatment eects, and we would have discussed the

clinical implications of treatment eects diering between trials.

We would have presented the results of meta-analysis as the

average treatment eect with 95% confidence intervals, and the

estimates of Tau and I.

For the outcome 'time to first bowel movement', we had planned

to pool hazard ratios in a meta-analysis using the generic inverse-

variance method, however the primary studies only reported the

numbers at each time point, which we summarized using risk ratios

separately per study.

Subgroup analysis and investigation of heterogeneity

We were not able to conduct subgroup analysis in this review,

since we did not perform any meta-analyses. If future updates

allow meta-analysis, we will use subgroup analyses to investigate

heterogeneity. We will carry out the following subgroup analyses.

1. Type of laxatives (osmotic laxatives versus stimulant laxatives;

bulk forming laxatives versus stimulant laxatives)

2. Study design (individually-randomised versus cluster-

randomised trials)

3. Mode of delivery (caesarean section versus spontaneous vaginal

delivery)

We will limit these subgroup analyses to the primary outcomes of

the review.

We will assess subgroup dierences by interaction tests available

within Review Manager 5 (Higgins 2011). We will report the results

of subgroup analyses quoting the Chi statistic and P value, and the

interaction test I value.

Sensitivity analysis

We were not able to conduct sensitivity analysis in this review, since

we did not perform any meta-analyses. For future updates of the

review, we will perform sensitivity analysis with respect to:

1. robustness of the methods used regarding allocation

concealment;

2. rates of attrition;

3. imputed values of intra-cluster correlations (ICC).

R E S U L T S

Description of studies

See Characteristics of included studies and Characteristics of

excluded studies.

Results of the search

See Figure 1.

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Figure 1.  Study flow diagram

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We included five trials in the previous version of this review (Turawa

2015b).

For this update, we retrieved three additional trial reports

(ChiCTR1900023067; Sakai 2015; IRCT20190427043386N1). Of

these, we excluded two studies, bringing the total number of

excluded studies for this review to four (ChiCTR1900023067; Liu

2009; Mahony 2004; Sakai 2015; see Characteristics of excluded

studies).

One trial is still ongoing, thus we included it under ongoing studies

(IRCT20190427043386N1; see Characteristics of ongoing studies).

We did not include any new studies in this update.

Included studies

Details of the included studies are provided in the 'Characteristics

of included studies' table.

We included five trials, with a total of 1208 participants. Of

the five trials, three were randomised controlled trials (Diamond

1968; Eogan 2007; Shelton 1980), and two were quasi-randomised

controlled trials (Mundow 1975; Zuspan 1960). Four of the trials

were from high-income countries, while the fih trial was from a

middle-income country (Shelton 1980). All trials were conducted in

a tertiary institution, and the unit of randomisation for all trials was

the individual. Trials were published in English; four of the trials

compared a pharmaceutical intervention (laxative) with a placebo,

while the fih trial compared a laxative plus bulking agent with the

same laxative, in the prevention of postpartum constipation. None

of the trials assessed non-pharmacological interventions.

Design

Of the five included trials, three were randomised controlled trials

(Diamond 1968; Eogan 2007; Shelton 1980), and two (Mundow

1975; Zuspan 1960) are quasi-randomised trials. The unit of

randomisation for all trials was the individual.

Setting

Four of the included trials were conducted in high-income

countries (Diamond 1968; Eogan 2007; Mundow 1975; Zuspan

1960). Diamond 1968 and Zuspan 1960 in the United Statas of

America; and Eogan 2007 and Mundow 1975 in Ireland. The fih trial

was conducted in South Africa, which is a middle-income country

(Shelton 1980). All trials were conducted in a tertiary healthcare

institution.

Participants

All included participants were postpartum women without

symptoms of constipation at enrolment. Diamond 1968 included

106 postpartum women (55 primiparous and 51 multiparous), with

normal vaginal delivery, between the ages of 15 and 41 years. Eogan

2007 included 147 postpartum women undergoing primary repair

of an anal sphincter tear sustained during normal vaginal delivery.

Mundow 1975 included 200 postpartum women (primiparous and

multiparous women); they did not specify the type of delivery.

Shelton 1980 included 511 postpartum women who had either a

spontaneous vaginal delivery or an assisted vaginal delivery; they

excluded those who delivered by caesarean section, or those who

sustained a third degree tear during vaginal delivery. Zuspan 1960

included 244 postpartum women; but did not report on the type of

delivery.

Interventions and comparisons

Four of the trials compared a pharmaceutical intervention

(laxative) to a placebo (Diamond 1968; Mundow 1975; Shelton

1980; Zuspan 1960). The laxatives used in the intervention groups

included Dioctyl-sodium succinate plus active senna (Zuspan

1960), active senna (Shelton 1980), Bisoxatin acetate (Diamond

1968), and Danthron/Poloxaikol (Dorbanex) Mundow 1975. The fih

trial compared a laxative plus a bulking-agent (oral lactulose plus

one sachet of Ispaghula husk) to the laxative alone (oral lactulose

(Eogan 2007)).

It has come to our attention that two of these drugs are no longer

indicated in postpartum women. Bisoxatin acetate is no longer

recommended for breastfeeding women (Diamond 1968; Omega

Pharma 2016); Danthron is no longer on the market in the USA

and other countries, as it is 'reasonably anticipated to be a human

carcinogen', based on animal studies (Mundow 1975; National

Toxicology Program 2016). Therefore, we will present the data of

these two studies separately, and not include them in the meta-

analysis.

Outcomes

The only primary outcome reported in the included studies was

time to first bowel movement. Diamond 1968 reported the number

of women with loose or watery stools and frequency of stool;

Eogan 2007 reported on pain or discomfort with bowel movement;

Shelton 1980 and Mundow 1975 reported on the number of

women having abdominal cramps; while Eogan 2007 reported

faecal incontinence as an adverse eect of the intervention. Shelton

1980 also reported on adverse eects of the intervention on the

baby. However, none of the included trials reported on pain or

straining on defecation, or changes in quality of life.

Dates of the study

Mundow 1975 was conducted between 5 May 1974 and 11 June

1974; Eogan 2007 was carried out between May 2003 and April 2004;

and Diamond 1968 was conducted between 11 April 1966 and 13

July 1966. Shelton 1980 and Zuspan 1960 did not provide the date

of their trials.

Funding sources

The drugs used in three of the trials were supplied by

pharmaceutical companies (Diamond 1968; Shelton 1980; Zuspan

1960). Diamond 1968 reported that the trial was supported by

Wyeth laboratories, Philadelphia, Pennsylvania, in the USA. Shelton

1980 reported that the drug used for the trial was supplied by

Reckitt & Colman Co., and that they also provided statistical

analysis. The drug used for Zuspan 1960 was from Purdue Fredrick

Co. Eogan 2007 was supported by the Irish Health research board.

There was no information on the funding source for Mundow 1975.

Declarations of interest

None of the included trials disclosed conflicts of interest.

Excluded studies

We excluded four trials (ChiCTR1900023067; Liu 2009; Mahony

2004; Sakai 2015). We excluded them because they did not

evaluate interventions to prevent postpartum constipation. See the

Characteristics of excluded studies.

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Ongoing studies

One trial is an ongoing trial (IRCT20190427043386N1). See

Characteristics of ongoing studies.

Risk of bias in included studies

We presented judgements regarding the risk of bias in each of the

included trials in the 'Characteristics of included studies' table.

Summary tables of risk of bias in all included trials are also

displayed in Figure 2 and Figure 3.



Figure 2.  'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages

across all included studies

Random sequence generation (selection bias)

Allocation concealment (selection bias)

Blinding of participants and personnel (performance bias): All outcomes

Blinding of outcome assessment (detection bias): All outcomes

Incomplete outcome data (attrition bias): All outcomes

Selective reporting (reporting bias)

Other bias

0% 25% 50% 75% 100%

Low risk of bias Unclear risk of bias High risk of bias



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Figure 3.  'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study

Random sequence generation (selection bias)

Allocation concealment (selection bias)

Blinding of participants and personnel (performance bias): All outcomes

Blinding of outcome assessment (detection bias): All outcomes

Incomplete outcome data (attrition bias): All outcomes

Selective reporting (reporting bias)

Other bias

Diamond 1968 ? ? ? + + + ?

Eogan 2007 + ? ? ? -+ +

Mundow 1975 - - ? + ? + ?

Shelton 1980 ? ? ? + -+-

Zuspan 1960 - - ? ? ? + ?

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Allocation

Allocation refers to both the generation of the random allocation

sequence and concealment of assignment to prevent selection

bias.

Generation of allocation sequence

Eogan 2007 used computer-generated numbers in ratio of 1:1 to

generate the allocation sequence, and thus we judged it at low risk

of selection bias. Two trials provided insuicient information to

enable us to judge whether there was a low or high risk of selection

bias, therefore, we judged them as unclear risk of selection bias

(Diamond 1968; Shelton 1980). The remaining two trials were quasi-

randomised trials, which did not indicate the method used to

generate allocation sequence; therefore, we considered both trials

at high risk of selection bias (Mundow 1975; Zuspan 1960).

Allocation concealment

We judged three trials as unclear risk of bias, since none of them

provided suicient information to enable us to judge whether the

trials were of either low or high risk of selection bias (Diamond

1968; Eogan 2007; Shelton 1980). Diamond 1968 used sealed and

identical envelopes, but the authors did not report whether they

were opaque and sequentially numbered. Eogan 2007 used sealed

opaque envelopes, where all the tablets (active and placebo) used

were identical in number and appearance, but did not explicitly

state whether the envelopes were sequentially numbered. We

emailed the corresponding author of Eogan 2007 requesting further

information on the method of allocation concealment, but did

not receive a response. For Shelton 1980, the tablets (active and

placebo) were identical in all respects, and women only received

drugs from a numbered bottle, allocated to them. We judged the

risk of bias to be high for the two quasi-randomised trials (Mundow

1975; Zuspan 1960). Contact details of corresponding authors were

not provided for the other trials.

Blinding

We assessed all included trials as unclear risk of performance

bias because it was unclear whether or not the participants and

personnel were adequately blinded to the assignment. There was a

lack of suicient and explicit information on the methods used for

blinding.

Diamond 1968 reported that participants and investigators were

not aware of the content of the identical drugs and envelopes,

but did not provide information on identical colour, shape,

and size of drug to enable explicit judgement. Eogan 2007

did not supply any information on blinding of participants,

personnel, and the investigators; we judged it as unclear risk

of bias for both performance and detection bias. Shelton 1980

reported that the trial was double-blind, but did not explicitly

explain what steps were followed to ensure adequate blinding

of the participants and personnel; we judged it as unclear of

performance bias. Zuspan 1960 stated that the trial was double-

blind, but failed to report on whether capsules were identical

in appearance, shape, and size, and provided no information on

blinding of participants and investigators; we judged it as unclear

of performance and detection bias. Mundow 1975 reported that the

active and placebo tablets were indistinguishable to participants

and observers, the code was only sent to the investigator at the

end of the study, but did not provide information on whether the

people administering the intervention were also prevented from

identifying the interventions; we judged it as low risk of detection

bias, but unclear risk of performance bias. Diamond 1968 reported

that "the knowledge of the random code number and type of drug

was not revealed till the completion of the study"; we judged it

at low risk of detection bias. Shelton 1980 stated that "statistical

analyst had no knowledge of which participants received active

treatment or placebo", and that the code was only broken at the

final stage of analysis; we judged it at low risk of detection bias.

Incomplete outcome data

Diamond 1968 reported adequately on all participants in the trial,

and included them in the final analysis; we considered it at low

risk of attrition bias. We assessed two trials at high risk of attrition

bias; Eogan 2007 reported that all participants attended the first

follow-up at 10 days postpartum, but 26/147 participants did not

turn up for assessment at three months following delivery, despite

repeated reminders. Of these, 24 gave a personal reason, and two

could not be traced and were therefore excluded from the final

analysis. The attrition rate was more than 15% in both groups; we

considered it at high risk of attrition bias. Forty of the participants

in Shelton 1980 were excluded from the analysis because the result

showed a small dierence, and the number was small (according to

trial authors); we judged it at high risk of attrition bias. We judged

two trials as unclear risk of attrition bias. Mundow 1975did not give

an explicit report of the number of participants in each trial group

and there was no flow diagram to illustrate the flow of participants.

Zuspan 1960 also did not provide adequate information on the flow

of participants in the trial.

Selective reporting

We judged all five included trials to be at low risk of selective

outcome reporting. There were no protocols available, but all the

outcomes prespecified in the methods section were adequately

reported.

Other potential sources of bias

Diamond 1968 and Zuspan 1960 were supported by drug

companies. There was no declaration of interest and the trial

authors did not specify whether the companies influenced the

results or not. Consequently we judged them as unclear risk of

other bias. We judged Mundow 1975 as unclear risk of bias, because

the trial report did not contain information on conflicts of interest,

funding sources, how the sample size was determined, or whether

they obtained ethical approval.

We judged Shelton 1980 at high risk of other bias. The authors

reported that the drugs used in the trial and statistical evaluation

were provided by a drug company, but provided no information

on declaration of interest, to ascertain whether the company

might have influenced the trial results or not. There was also no

information relating to ethical approval.

Eogan 2007 appeared to be at low risk of other bias.

Eects of interventions

See: Summary of findings 1 Laxative compared to placebo

for preventing postpartum constipation; Summary of findings

2 Laxative plus bulking agent compared to laxative alone for

preventing postpartum constipation

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The five included trials examined two dierent comparisons

(Diamond 1968; Eogan 2007; Mundow 1975; Shelton 1980; Zuspan

1960).

Comparison 1 ‒ Laxative versus placebo

Four included trials examined the eectiveness and safety of a

laxative versus a placebo control (Diamond 1968; Mundow 1975;

Shelton 1980; Zuspan 1960; Summary of findings 1). We present

the data for this comparison narratively, as the laxative used in

one study is no longer recommended for breastfeeding women

(Bisoxatin acetate; Diamond 1968), and another has been shown to

be carcinogenic in animals, and is no longer allowed to be marketed

(Danthron; Mundow 1975).

Primary outcomes

Pain or straining on defecation

None of the trials evaluating this comparison reported on pain or

straining during defecation.

Incidence of postpartum constipation, as per self-report and other

diagnostic criteria

None of the trials evaluating this comparison reported on the

incidence of postpartum constipation.

Quality of life, as measured in included studies (using, e.g. maternal

postpartum quality of life (MAPP-QOL) questionnaire)

None of the trials evaluating this comparison reported on quality

of life.

Time to first bowel movement (days)

Four trials reported on this outcome (Diamond 1968; Mundow 1975;

Shelton 1980; Zuspan 1960). Three trials reported on the number of

women having their first bowel movement on the day of delivery,

day one, day two, day three, and day four. Zuspan 1960 reported

the mean days to first bowel movement.

Number of women having their first bowel movement in less than 24

hours

Compared to placebo, a laxative (senna) may increase the number

of women having their first bowel movement in less than 24 hours

(142/224 (63%) versus 54/247 (21.9%); risk ratio (RR) 2.90, 95%

confidence interval (CI) 2.24 to 3.75, 1 trial, 471 women; low-

certainty evidence; Analysis 1.1; Shelton 1980).

Number of women having their first bowel movement on day one

Three trials reported the number of women having their first bowel

movement on day one; we are giving results separately for each

study, since each trial used a dierent laxative.

Compared to placebo, a laxative (senna) may result in little to

no dierence in the number of women having their first bowel

movement on day one but the evidence is very uncertain (69/224

(31%) versus 81/247 (33%); RR 0.94, 95% CI 0.72 to 1.22; 1 trial, 471

women; very low-certainty evidence; Analysis 1.2; Shelton 1980).

The laxatives used in these two trials are no longer used. In one trial,

more women in the laxative group had their first bowel movement

on day one, compared with placebo (23/54 (43%) versus 11/52

(21%); RR 2.01, 95% CI 1.09 to 3.70; 1 trial, 106 women; Analysis 1.2;

Diamond 1968). In the second trial, fewer women in the laxative

group had their first bowel movement on day one, compared with

placebo (7/100 (7%) versus 9/100 (9%); RR 0.78, 95% CI 0.30 to 2.01;

1 trial, 200 women; Analysis 1.2; Mundow 1975).

Number of women having their first bowel movement on day two

Three trials reported the number of women having their first bowel

movement on day two; we are providing the results separately for

each study, since each trial used a dierent laxative.

Compared to placebo, a laxative (senna) may reduce the number of

women having first bowel movement on day two (9/224 (4%) versus

44/247 (18%); RR 0.23, 95% CI 0.11 to 0.45; 1 trial, 471 women; low-

certainty evidence; Analysis 1.3; Shelton 1980).

The laxatives used in these trials are no longer used. In one study,

more women in the laxative group had their first bowel movement

on day two, compared with placebo (26/54 (48%) versus 9/52 (17%);

RR 2.78, 95% CI 1.44 to 5.36, 1 trial, 106 women; Analysis 1.3;

Diamond 1968). In the second study, more women in the laxative

group also had their first bowel movement on day two, compared

with placebo (49/100 (49%) versus 12/100 (12%); RR 4.08, 95% CI

2.32 to 7.20; 1 trial, 200 women; Analysis 1.3; Mundow 1975).

Number of women having their first bowel movement on day three

Two trials measured this outcome. We are providing the results

separately for each study, since each trial used a dierent laxative.

Compared to placebo, a laxative (senna) may reduce the number

of women having first bowel movement on day three (0/224 (0%)

versus 10/247 (4%); RR 0.05, 95% CI 0.00 to 0.89; 1 trial, 471 women;

low-certainty evidence; Analysis 1.4; Shelton 1980).

The laxative used in Mundow 1975 is no longer used. Fewer women

had their first bowel movement on day three with the laxative,

compared with placebo (30/100 (30%) versus 33/100 (33%); RR 0.91,

95% CI 0.60 to 1.37; 1 trial, 200 women; Analysis 1.4).

Number of women having their first bowel movement on day four

Two trials measured this outcome. We are providing the results

separately for each study, since each trial used a dierent laxative.

It is uncertain if laxative (senna), compared with placebo, has any

eect on the number of women having their first bowel movement

on day four (1/224 (0.4%) versus 5/247 (2%); RR 0.22, 95% CI 0.03 to

1.87; 1 trial, 471 women; very low-certainty evidence; Analysis 1.5;

Shelton 1980).

The laxative used in Mundow 1975 is no longer used. Fewer women

in the laxative group had their first bowel movement on day four,

compared to placebo (14/100 (14%) versus 38/100 (38%); RR 0.37,

95% CI 0.21 to 0.64; 1 trial, 200 women; Analysis 1.5).

Number of days to first bowel movement

Zuspan 1960 reported that the mean number of days before the

first bowel movement was 2.48 days for the laxative group versus

2.55 days for the placebo group. However, since they did not report

standard deviations or P values, we were unable to analyse these

data further.

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Secondary outcomes

Stool consistency using the Bristol Stool Form Scale (BSFS)

None of the trials evaluating this comparison reported on stool

consistency using the BSFS.

The laxative used in Diamond 1968 is no longer used. Compared to

placebo, the laxative may increase the number of women having

loose or watery stools (28/54 (51.9%) versus 1/52 (1.9%); RR 26.96,

95% CI 3.81 to 191.03; 1 trial, 106 women; Analysis 1.6). The CI is

wide because there was only one event in the placebo group.

Use of alternative products, laxative agents, enemas

Compared to the placebo, a laxative (dioctyl-sodium succinate

+ senna) may result in little to no dierence in the number of

postpartum enemas given (20/123 (16.3%) versus 31/121 (25.6%);

RR 0.63, 95% CI 0.38 to 1.05; 1 trial, 244 women; Analysis 1.7; Zuspan

1960).

The laxative used in Mundow 1975 is no longer used. Compared

to placebo, a laxative may reduce the number of women receiving

suppositories or enemas (7/100 (7%) versus 24/100 (24%); RR 0.29,

95% CI 0.13 to 0.65; 1 trial, 200 participants; Analysis 1.8).

Relief of abdominal pain or discomfort

None of the trials evaluating this comparison reported on relief of

abdominal pain or discomfort.

Stool frequency

The laxatives used in these two trials are no longer used.

Compared to placebo, a laxative may increase the number of

women having more than two bowel movements per day (13/54

(24.1%) versus 0/52 (0%); RR 26.02, 95% CI 1.59 to 426.73; 1 trial, 106

women; Analysis 1.9; Diamond 1968). The CI is wide because there

were no events in the placebo group.

Mundow 1975 (200 women) reported the number of days (from

zero to five days) that women recorded bowel movements (Analysis

1.10). Compared to placebo, a laxative may reduce the number of

women having no bowel movement for five days (0/100 (0%) versus

9/100 (9%); RR 0.05, 95% CI 0.00 to 0.89); may result in little to

no dierence in the number of women having bowel movements

on days one, three, and five; may reduce the number of women

having bowel movements on day two (25/100 (25%) versus 42/100

(42%); RR 0.60, 95% CI 0.39 to 0.90); and may increase the number of

women having bowel movements on day four (27/100 (27%) versus

10/100(10%); RR 2.70, 95% CI 1.38 to 5.28).

Adverse eects caused by the intervention

Two trials reported on the number of women having abdominal

cramps.

Compared to placebo, a laxative (senna) may increase the number

of women having abdominal cramps (23/224 (10.3%) versus 6/247

(2.4%); RR 4.23, 95% CI 1.75 to 10.19; 1 trial, 471 women; low-

certainty evidence; Analysis 1.11; Shelton 1980).

Fewer women in the laxative group had abdominal cramps

compared with the placebo group (1/100 versus 4/100; RR 0.25, 95%

CI 0.03 to 2.20; 1 trial, 200 women; Analysis 1.11; Mundow 1975). The

laxative used in this trial is no longer used.

Adverse eects of the intervention on the baby

Shelton 1980 reported on adverse eects of the intervention on the

baby.

Compared to placebo, a laxative (senna) for mothers may have little

or no eect on loose stools in their babies (RR 0.62, 95% CI 0.16 to

2.41; 1 trial, 281 babies; very low-certainty evidence), or diarrhoea

(RR 2.46, 95% CI 0.23 to 26.82; 1 trial, 281 babies; very low-certainty

evidence; Analysis 1.12).

Comparison 2 ‒ Laxative plus a bulking agent versus laxative

alone

One trial compared a laxative plus a bulking agent (lactulose

plus a sachet of Ispaghula husk) versus laxative (lactulose) alone

in women who had sustained sphincter injuries during vaginal

delivery, and had subsequently undergone surgical repair of the

tear (Eogan 2007; Summary of findings 2).

Primary outcomes

Pain or straining on defecation

Eogan 2007 reported on the level of pain or discomfort with the first

postpartum bowel movement using a Likert scale (1 = no pain to 5 =

excruciating pain) during the first 10 days postpartum. The median

(range) pain score for both study groups was one (1 to 5), with

no clear dierences between the two groups (P = 0.11; very low-

certainty evidence) as reported by trial authors. We were unable

to further analyse these data, since they were only reported as

medians (range).

Incidence of postpartum constipation, as per self-report and other

diagnostic criteria

Eogan 2007 reported there was no dierence in incidence of

postpartum constipation (data not reported).

Quality of life, as measured in included studies (using, e.g. maternal

postpartum quality of life (MAPP-QOL) questionnaire)

The trial evaluating this comparison did not report on change in

quality of life.

Time to first bowel movement (days)

Eogan 2007 reported that the first postpartum bowel motion

occurred at a median of three days (range one to six) for the group

who took the laxative plus bulking agent and a median of three days

(range one to five) for the group who took laxative alone; the trial

authors reported little to no dierence between the two treatment

groups (P = 0.34; very low-certainty evidence).

Secondary outcomes

Stool consistency using Bristol Stool Form Scale

The trial evaluating this comparison did not report on stool

consistency.

Use of alternative products, laxative agents, enemas

The trial evaluating this comparison did not report on use of

alternative products, laxative agents, or enemas.

Relief of abdominal pain or discomfort

The trial evaluating this comparison did not report on relief of

abdominal pain or discomfort.

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Stool frequency

The trial evaluating this comparison did not report on stool

frequency.

Adverse eects caused by the intervention

Eogan 2007 reported incontinence using a bowel function

questionnaire with a score from 0 to 20 (0 = incomplete continence

to 20 = complete incontinence). Scores were assigned according to

participant's symptoms, including faecal urgency or incontinence,

and flatus incontinence, on day three, day 10, and aer three

months postpartum. The incontinence score on day three was

significantly higher in the laxative plus bulking agent group

(median 1; range 0 to 10) compared to the laxative alone group

(median 0; range 0 to 12; P = 0.02), as reported by trial authors.

There was little to no dierence in the incontinence scores between

the two groups at three months postpartum (laxative plus bulking

agent median 0 (range 0 to 6) versus laxative median 0 (range 0 to

10); P = 0.57; as reported by trial authors). No further analysis was

possible since results were only reported as medians (range).

The trial also reported the number of participants having any

episode of faecal incontinence during the first 10 postpartum

days. Compared to laxative alone, laxative plus bulking agent

may increase the number of women having any episode of faecal

incontinence during the first 10 postpartum days, but the evidence

is very uncertain (RR 1.81, 95%CI 1.01 to 3.23; 1 trial, 147 women;

very low-certainty evidence; Analysis 2.1).

Adverse eects of the intervention on the baby

The trial included in this comparison did not report on adverse

eects of the intervention on the baby.

D I S C U S S I O N

Summary of main results

The objective of this review was to update a previous review,

assessing the eectiveness and safety of dierent interventions for

preventing postpartum constipation (Turawa 2015b). We did not

identify new trials that met our inclusion criteria. We reviewed and

updated the previously included five trials (involving a total of 1208

postpartum women) according to MECIR guidelines and assessed

the certainty of evidence using GRADE.

We did not include the results of two trials in our main findings,

as one assessed the eects of Danthron, a drug shown to have

carcinogenic properties in animals (Mundow 1975), while the

other trial assessed the eects of Bisoxatin Acetate, which is not

recommended for use when breastfeeding (Diamond 1968). As

these trials meet eligibility criteria, we included them and reported

on the results in a narrative way.

For comparison 1 (laxative versus placebo), none of the included

trials reported on pain or straining on defecation, incidence of

postpartum constipation, or changes in quality of life.

We included results from one trial, assessing the eects of senna

tablets compared to placebo in Summary of findings 1 (Shelton

1980). Results suggest that laxatives compared to placebo may

increase the number of women having their first bowel movement

in less than 24 hours aer delivery, and may reduce the number of

women having their first bowel movement on days 2 and 3 aer

delivery, but the evidence is low certainty. Laxatives may have

little or no eect on the number of women having their first bowel

movement on day 1 or day 4 aer delivery, but the evidence is

very uncertain. In terms of adverse eects, laxatives may increase

the number of women experiencing abdominal cramps, and may

increase the number of babies having loose stools or diarrhoea

compared to placebo, but the evidence is very uncertain for most

of these outcomes.

One trial, assessing the eects of dioctyl-sodium succinate and

senna compared to placebo, reported the mean number of days

before the first bowel movement was 2.48 days for the laxative

versus 2.55 days for the placebo groups. However, since there were

no standard deviations and P values reported we were unable to

analyse these data further (Zuspan 1960).

For comparison 2 (laxative plus bulking agent versus laxative

alone), we included one trial, comparing oral lactulose plus

a bulking agent (Ispaghula husk) versus the same laxative in

postpartum women who underwent surgical repair of a third-

degree perineal tear (Eogan 2007). The trial authors reported no

dierence between groups in pain or straining on defecation.

However, they only reported the medians and ranges for both

groups, and we were unable to analyse the data further. Trial

authors reported no dierence in the incidence of self-reported

postpartum constipation (data not available) and no dierence in

time to first bowel movement (median and ranges reported). In

terms of adverse eects, results of the trial suggest that compared

to laxative alone, laxative plus bulking agent may increase the

number of women having faecal incontinence during the first 10

postpartum days, but the evidence is very uncertain. The trial did

not report on any adverse eects on the baby.

Overall completeness and applicability of evidence

The five trials were conducted in three dierent countries (USA,

Ireland, and South Africa), all in tertiary hospitals. All trials except

Eogan 2007, were published more than 40 years ago.

All included trials assessed pharmaceutical interventions to

prevent postpartum constipation. Of these, one trial assessed the

eects of Danthron (Mundow 1975), a laxative that has shown to

have carcinogenic eects in animals, and is no longer marketed

in most countries (Barth 1984; National Toxicology Program 2016;

Sunitha 2016; Xing 2001). Another trial assessed the eects of

Bisoxatin acetate (Diamond 1968), a drug currently marketed under

the trade name Wylaxine, which is not recommended for use

during lactation (Omega Pharma 2016). Although we included

these studies in the review, we presented the results separately

from our main findings, as these drugs can be harmful when used

in postpartum women.

The use of dioctyl-sodium succinate, a laxative assessed in

combination with senna in the trial by Zuspan 1960, has

been widely debated, with calls to remove it from hospitals'

formularies, as it has been shown to be ineective (CADTH 2014;

Fakheri 2019; MacMillan 2016; Ramkumar 2005). Others have also

expressed some concerns about using dioctyl-sodium succinate

when breastfeeding.

The only drug currently listed on the WHO's list of essential

medicines for breastfeeding women is senna, and its use is

recommended only when dietary measures have failed (WHO 2002).

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The trial we included in the 'Summary of findings' table assessed

the eects of senna tablets on preventing postpartum constipation

(Shelton 1980).

Eogan 2007 evaluated two dierent interventions amongst women

who had undergone surgical repair of a third degree perineal tear.

This is a very specific group of trial participants, and therefore, the

results cannot be extrapolated to the general postpartum woman.

The pain experienced with the first bowel movement was most

likely attributable to pain from the perineal tear and surgery, and

not necessarily to constipation. Fear of pain can also play a role in

this group of women, which might lead to constipation.

None of the trials assessed other interventions, such as dietary

advice and modification, promotion of healthy physical activities,

or the correct positioning for defecation, which also have an

important place in promoting bowel movements during the

postpartum period. Consideration should also be given to other

factors that might influence postpartum bowel movements, such as

the administration of enemas before labour, the ability of women

to eat during active labour, irregular and altered eating habits

during the first few days aer delivery, and fear of pain from a

repaired perineal tear or episiotomy, especially third degree tears,

which could involve the anal sphincter. None of these factors were

reported in the included trials. Included trials only assessed bowel

movements during the first five days aer delivery. Constipation

can become a problem at a later stage, even up to six months

postpartum (Van Brummen 2006). Factors, such as limited physical

exercise, irregular and altered dietary pattern, insuicient intake of

fluids, and emotional concerns of being a new mother, may have

a negative influence on bowel movements during this period (NIH-

NIDDK 2018).

Only a few adverse eects were reported in the included

trials, therefore, there is insuicient evidence to make general

conclusions on safety and eectiveness of these interventions.

Quality of the evidence

All the five trials included in this review lacked methodological

rigour, and four of the five trials were published prior to 1980.

We did not include studies that assessed drugs that are harmful

or contra-indicated for breastfeeding women in the 'Summary of

findings' table, as this would not be useful for decision-makers.

For the comparison 'Laxative versus placebo', we only included one

study in Summary of findings 1 (Shelton 1980). We downgraded

the certainty of evidence by two levels due to very serious study

limitations (high risk of attrition bias, high risk of other bias due

to industry sponsorship and statistical analysis, and unclear risk

of selection bias). We downgraded the certainty of evidence by

another level due to imprecision, as findings were based on a single

study with few participants, with results that had wide confidence

intervals that crossed the line of no eect. The study excluded

women who had delivered via caesarean section, or who had third

degree tears, a population in which laxatives would be indicated,

due to pain and fear when straining. Therefore, the certainty of

evidence was low or very low for all outcomes, and we have very

little confidence in the eect estimate.

For the comparison 'Laxative plus bulking agent compared to

laxative alone', we included one study in Summary of findings 2

(Eogan 2007). We downgraded the certainty of evidence by one

level due to study limitations (high risk of attrition bias, unclear risk

of selection, performance, and detection bias). We downgraded by

another level due to imprecision, as the results were based on a

single study, with a small sample size, and results that had wide

confidence intervals, crossing the line of no eect. We downgraded

by one level due to indirectness, as results were from a single

study, conducted in Ireland, and participants only included women

undergoing surgical repair of third degree perineal tears. Therefore,

the certainty of evidence was very low for all outcomes, and we

have very little confidence in the eect estimate.

Potential biases in the review process

We attempted to minimise potential bias in this review in a

number of ways. The Cochrane Pregnancy and Childbirth group

Information Specialist conducted a comprehensive trial search to

include published and unpublished trials in all languages. At least

two review authors independently scrutinised and selected trials

for inclusion in the review using eligibility criteria, assessed risk

of bias, and extracted data. We were unable to examine reporting

biases using funnel plots, as we had fewer than 10 included trials in

a meta-analysis. We had planned to analyse the primary outcome

'number of days to first bowel movement' using time-to-event

analysis methods, but we were unable to do this, due to insuicient

individual patient data. The separate analyses per day did not take

account of the fact that the denominator was decreasing as the

number of days aer delivery increased, due to the fact that once a

woman experienced the event, they could not experience the event

again. As four of the included trials were published more than 40

years ago; we were unable to contact authors to obtain missing data

or information.

Agreements and disagreements with other studies or

reviews

There is no other systematic review on interventions for preventing

postpartum constipation. Our review on interventions to treat

postpartum constipation did not identify any trials to include

(Turawa 2014). The Cochrane Review on interventions to treat

constipation during pregnancy included four trials, all published

more than 30 years ago (Rungsiprakarn 2015) Included trials also

did not report on pain on defecation and quality of life. Authors

concluded that there was 'insuicient evidence to comprehensively

assess the eectiveness and safety of interventions'.

Dietary fibre, in the form of wheat and brans, oers relief for

constipation in non-pregnant mothers, and raises no serious

concerns about side eects to mother and baby. Other measures,

such as behavioural and educational interventions, increased

exercise, and positioning during bowel movement, were not

discussed in the included trials. Symptomatic rectal haemorrhoids

also play a significant role in postpartum constipation, and dietary

fibre seems to oer eective treatment in relieving haemorrhoids,

which may contribute to constipation (Alonso-Coello 2005).

A U T H O R S '  C O N C L U S I O N S

Implications for practice

Overall, there is insuicient evidence to make general conclusions

about the eectiveness and safety of laxatives for preventing

postpartum constipation. Laxatives compared to placebo may lead

to more women having a bowel movement during the first 24

hours aer delivery, and fewer women having the first bowel

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movement on day two and three aer delivery, but the evidence

is very uncertain. Adverse events were poorly reported. We are

very uncertain whether laxatives plus bulking agent compared to

laxatives alone have an eect on pain or straining on defecation,

and time to first bowel movement. Laxatives plus bulking agent

may increase the incidence of faecal incontinence during the first

10 days postpartum, but the evidence is very uncertain.

We found no evidence for pain or straining on defecation,

incidence of postpartum constipation, or quality of life from studies

comparing laxatives to placebo; we did not identify any trials

assessing educational or behavioural interventions.

Trials did not follow participants through the entire postpartum

period, so we did not find any evidence on the eectiveness and

safety regarding the use of laxatives during the entire postpartum

period, up to six months.

Implications for research

There are few trials on interventions for preventing postpartum

constipation, which report on the following important outcomes:

pain or straining on defecation, incidence of postpartum

constipation, quality of life, time to first bowel movement aer

delivery, or adverse eects caused by the intervention, such as:

nausea or vomiting, pain, or flatus. No trials evaluating non-

pharmacological interventions, such as acupuncture, educational

or behavioural interventions, or positioning during bowel

movements are currently available. As some drugs are not

recommended for use when breastfeeding, future trials should

focus on assessing educational and behavioural interventions,

aimed at promoting a healthy diet and physical activity in

preventing postpartum constipation.

Large, rigorous, randomised controlled trials are needed to address

the safety and eectiveness of laxatives for preventing constipation

during the entire postpartum period.

A C K N O W L E D G E M E N T S

We acknowledge the Pregnancy and Childbirth Group's

Information Specialists for their immerse contribution to the

template for the search strategy for identification of studies.

All authors were partly supported by the Research, Evidence

and Development Initiative (READ-It) project (project number

300342-104). READ-It is funded by aid from the UK government;

however, the views expressed do not necessarily reflect the UK

government’s oicial policies.

We acknowledge Charles Okwundu for giving content advice on the

protocol.

E Turawa acknowledged Cochrane South Africa, Cape Town, South

Africa for providing guidance in conducting this systematic review.

As part of the pre-publication editorial process, this review has

been commented on by three peers (an editor and two referees who

are external to the editorial team), two members of the Pregnancy

and Childbirth Group's international panel of consumers, and the

Group's Statistical Adviser.

This project was supported by the National Institute for Health

Research (NIHR), via Cochrane Infrastructure funding to Cochrane

Pregnancy and Childbirth. The views and opinions expressed

therein are those of the authors and do not necessarily reflect those

of the Evidence Synthesis Programme, the NIHR, National Health

Service (NHS) or the Department of Health and Social Care.

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

* Indicates the major publication for the study



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C H A R A C T E R I S T I C S  O F  S T U D I E S

Characteristics of included studies [ordered by study ID]



Study characteristics

Methods Study design: randomised controlled trial.

Trial duration: 12 weeks (11 April 1966 to 13 July 1966)

Trial location: University of Minnesota Hospitals, Minneapolis, USA

Participants Number of participants: 106 postpartum women aged 15 to 41 years

Intervention group: 54 women (29 primiparous and 25 multiparous)

Control group: 52 women (26 primiparous and 26 multiparous)

Interventions Intervention: Bisoxatin acetate (3 tablets); 1 tablet was given orally 1st day postpartum and if no bowel

action occur that 1st day, the dose was increased to 2 tablets on the 2nd day. If no bowel activity occur

by the 3rd day, another form of laxative was used.

Control: lactose placebo (3 tablets)

Outcomes Primary outcomes

1. Number of participants having their first bowel movement by day 1, day 2, and day 3

2. Number of stools per day

3. Side effects: diarrhoea, loose or watery stool

Notes Ethics approval: not stated

Correspondence with authors: no email address available. We would have requested details regarding

risk of bias, for instance whether random number tables or a computer were used in random sequence

generation.

Dates of study: study was conduct between 11 April 1966 and 13 July 1966

Funding sources: study was supported by the Wyeth Laboratories, Philadelphia, Pennsylvania, USA

Declarations of interest: no comment provided

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence genera-

tion (selection bias)

Unclear risk Quote "Each patient was assigned a number according to a random code".

It was unclear how the random sequence was generated.

Allocation concealment

(selection bias)

Unclear risk Quote "Identical envelopes and drugs were used".

It was unclear whether adequate precautions were taken to conceal the as-

signment from the participants and investigators.

Blinding of participants

and personnel (perfor-

mance bias)

All outcomes

Unclear risk Quote "The patients and investigators were not aware of the content of the

identical drugs and envelopes".

Diamond 1968

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Insufficient information on identical colour, shape, and size of drug to enable

explicit judgement.

Blinding of outcome as-

sessment (detection bias)

All outcomes

Low risk Quote "The knowledge of the random code number and type of drug was not

revealed till the completion of the study".

Incomplete outcome data

(attrition bias)

All outcomes

Low risk No missing outcome data. All women enrolled were included in the final analy-

sis.

Selective reporting (re-

porting bias)

Low risk No published protocol available, but all outcomes that were prespecified in

the methods session were addressed.

Other bias Unclear risk The study was supported by Wyeth Laboratories, but the trial authors did not

specify whether the drug company influenced the results.

Diamond 1968(Continued)



Study characteristics

Methods Study design: randomised controlled trial

Trial duration: 12 months (May 2003 to April 2004)

Trial location: National Maternity Hospital, Holles St Dublin, Ireland

Participants Participants: 147 postpartum women with sphincter injury at vaginal delivery, undergoing primary re-

pair of a recognised anal sphincter tear

Intervention group: 70 postpartum women

Control group: 77 postpartum women

Exclusion criteria: history of colorectal disease, inflammatory bowel disease, diabetes mellitus, or col-

orectal malignancy

Interventions Intervention: oral lactulose 10 mL thrice daily for the first 3 postpartum days, followed by sufficient lac-

tulose to maintain a so stool for 10 days, plus 1 sachet of Ispaghula husk for 10 days

Control: oral lactulose 10 mL thrice daily for the first 3 postpartum days, followed by sufficient lactulose

to maintain a so stool for 10 days

All women were given routine antibiotics (co-amoxyclavulanic acid); erythromycin and metronidazole

were used in those with penicillin allergy

All participants were provided with a diary card to keep record of their bowel habits and movements for

10 days

Opiate was avoided in both groups

Outcomes Primary outcomes

1. Discomfort with 1st postpartum bowel motion (using pain scale from 1 = no pain to 5 = excruciating

pain)

2. Incidence of postnatal constipation and incontinence

Secondary outcomes

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1. Time until first bowel motion

2. Duration of postnatal stay

3. Symptomatic and functional outcomes 3 months postpartum

All participants were provided with a diary card to keep record of their bowel habits and movements for

10 days; opiate was avoided in both groups

Notes Funding: the study was supported by the Irish Health research board

Correspondence: email was sent to the author (colm.oherlihy@ucd.ie) requesting further information

on method used to ensure adequate concealment of the assignment and blinding processes, but there

was no response.

Dates of study: the study was conducted between May 2003 and April 2004

Funding sources: the study was supported by the Irish Health research board

Declarations of interest: not disclosed

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence genera-

tion (selection bias)

Low risk Randomisation was carried out using computer-generated allocations.

Allocation concealment

(selection bias)

Unclear risk ''Sealed opaque envelopes were used to concealed allocation identity''.

It was not specified whether the envelopes were sequentially numbered to

prevent selection bias.

Blinding of participants

and personnel (perfor-

mance bias)

All outcomes

Unclear risk There was no explicit information on blinding of the participants, personnel,

and investigators to the assignment.

Blinding of outcome as-

sessment (detection bias)

All outcomes

Unclear risk Insufficient information to judge whether the assessors were blinded to the as-

signment or not

Incomplete outcome data

(attrition bias)

All outcomes

High risk All participants attended the first 10 day follow-up; 26 did not attend post-

partum review at 3 months despite 2 repeated appointment-reminders being

sent, 24 of whom gave a personal reason and 2 could not be traced

Attrition rate in intervention group (LG) = 16%

Attrition rate in control group (FG) = 20%

Selective reporting (re-

porting bias)

Low risk All outcomes that were prespecified in the methods were addressed.

Other bias Low risk The study appeared to be free of other sources of bias.

Eogan 2007(Continued)



Study characteristics

Mundow 1975

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Methods Study design: quasi-randomised trial

Trial duration: 6 weeks (5 May 1974 to 11 June 1974)

Trial location: St James' Hospital Dublin. Ireland

Participants 200 normal postpartum women

Intervention group: 100 primiparous and multiparous women

Control group: 100 primiparous and multiparous women

Interventions Intervention: Danthron/Poloxalkol (Dorbanex). Each patient was given 2 yellow capsules at 18:00 hour

every evening, starting from the 3rd day of delivery, for the next 3 days (6 capsules). The capsules were

taken from numbered bottles.

Control: placebo - author did not give name of placebo; it was stated that an identical code was used

for both the placebo and experimental intervention

Outcomes Outcomes

1. Number of days to first bowel movement

2. Visible haemorrhoids

3. Abdominal pain

Secondary outcomes

4. Diarrhoea

5. Nausea

6. Urine discolouration

Notes There was no information on number of participants in each arm of intervention. Ethical approval not

stated, and declaration of interest not provided. The funding organisation was not reported.

Dates of study: study was conducted between 5 May 1974 to 11 June 1974

Funding sources: no information on how the study was funded

Declarations of interest: not disclosed

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence genera-

tion (selection bias)

High risk Quote ''Consecutive patients were enrolled into study"

Randomisation component not explicitly stated, quasi-randomised trial

Allocation concealment

(selection bias)

High risk Quasi-randomised trial

Blinding of participants

and personnel (perfor-

mance bias)

All outcomes

Unclear risk Quote "The placebo and the active capsules were indistinguishable to the par-

ticipant".

No information on the personnel, or method used in blinding both participant

and the personnel

Mundow 1975(Continued)

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Blinding of outcome as-

sessment (detection bias)

All outcomes

Low risk Quote "The code which identified the active from the placebo was held at Rik-

er Laboratories at Loughborough, and was sent to the investigator only at the

end of the study, the active and placebo were indistinguishable".

Incomplete outcome data

(attrition bias)

All outcomes

Unclear risk The number of participants in each group was not stated explicitly and there

was no flow diagram to illustrate this.

Selective reporting (re-

porting bias)

Low risk Study protocol was not available, but all outcomes specified in the method

section were addressed.

Other bias Unclear risk There was no information on conflicts of interest, how sample size was deter-

mined; no comment was made on ethical approval. The funding organisation

was not reported.

Mundow 1975(Continued)



Study characteristics

Methods Study design: randomised controlled trial

Trial setting: multi-centre

Trial location: Department of Obstetrics and Gynaecology, University of Cape Town, Groote Schuur

Hospital, and Peninsula Maternity Hospitals, Cape Town, South Africa

Participants Participants: 511 normal postpartum women with vaginal delivery

White postpartum women: 267 (from GrooteSchuur Hospital)

Coloured postpartum women: 204 (Peninsula Maternity Hospital)

Black postpartum women: 40

Exclusion criteria: women delivered by caesarean section or complicated by 3rd degree perineal tear

Interventions Intervention: active senna tablets - 2 tablets were given in the morning and 2 tablets in the evening im-

mediately after delivery, and 2 tablets twice daily until bowel action occurred or end of regimen (16

tablets used up)

Control: placebo (powdered corn flakes and dried grass)

Outcomes Primary outcomes

1. Initial spontaneous bowel movement within the first 24 hours of delivery

2. Initial spontaneous bowel movement within 48 hours of delivery

3. First bowel movement on the third day of delivery

4. Time of dosage

5. Time and nature of bowel action

Infant side effects

1. Loose stools or diarrhoea

2. Number, colour, and nature of stools for duration of trial

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3. Proportion of babies with normal stools

4. Mode of feeding

Secondary outcomes

1. Enema during labour and state of perineum following delivery

2. Maternal side effects: e.g. abdominal colic pains

3. Mode of delivery

Notes Sponsor: the drugs were supplied by Reckitt & Colman, and statistical evaluation provided by them

Ethics approval: not stated

Decaration of interest: not disclosed

Dates of study: date of the study was not provided by the authors

Funding sources: drugs used in the trial and the analysis was done by Reckitt & Colman Company

Declarations of interest: not disclosed

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence genera-

tion (selection bias)

Unclear risk Quote ''Trial preparation was administered according to a strict double - blind

random selection procedure".

Author did not provide sufficient information on how randomisation was

done.

Allocation concealment

(selection bias)

Unclear risk Quote ''tablets (active and placebo) were identical in all respects and patient

only received drugs from a numbered bottle allocated to her''.

The authors did not provide sufficient information to enable a clear judge-

ment.

Blinding of participants

and personnel (perfor-

mance bias)

All outcomes

Unclear risk Quote "Treatment assignment was masked from all study personnel and par-

ticipants for the duration of the study".

Information on methods used to mask the colour, shape, and size was not sup-

plied.

Blinding of outcome as-

sessment (detection bias)

All outcomes

Low risk Quote "Statistical analyst had no knowledge of which patients received active

treatment or placebo".

The code was only broken at the final stage of analysis.

Incomplete outcome data

(attrition bias)

All outcomes

High risk The results of 40 participants were not included because the results showed

minimal differences.

Selective reporting (re-

porting bias)

Low risk All the prespecified outcomes in the method section were addressed ade-

quately.

Other bias High risk Sponsor: the drugs used were supplied by Reckitt & Colman and statistical

evaluation provided by them

Ethics approval: not stated

Shelton 1980(Continued)

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Declaration of interest: not disclosed

Shelton 1980(Continued)



Study characteristics

Methods Study design: quasi-randomised trial

Trial setting: Department of Obstetrics and Gynaecology, University Hospital Cleveland, Ohio. USA

Trial location: USA

Participants 244 postpartum women

Interventions Intervention: Dioctyl-sodium succinate (50 mg) + senna (225 mg); 1 capsule twice daily. The 1st capsule

was given as soon postpartum as practical. No other laxative drugs given except enema saponis at pa-

tients’ request.

Control: capsulated inert ingredients (placebo), 1 capsule twice daily. 1st dose given as soon postpar-

tum as practical. No other laxative administered except enema saponis at patients’ request.

Outcomes 1. Number of days before 1st spontaneous bowel movement

2. Number of capsule (laxative) taken before 1st spontaneous bowel movement

3. Number of postpartum enemas given

Notes Purdue Fredrick Co. supplied the laxative (Senokap) used for the trial

Dates of study: no information supplied

Funding sources: the laxative used for the trial was supplied by Purdue Fredrick Co.

Declarations of interest: not declared

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence genera-

tion (selection bias)

High risk There was no information on random allocation sequence generation method

(quasi-RCT).

Allocation concealment

(selection bias)

High risk Quasi-randomised trial

Blinding of participants

and personnel (perfor-

mance bias)

All outcomes

Unclear risk Quote "All patients received double blinded capsule as soon postpartum as

practical and they were intentionally not told whether the capsule was a laxa-

tive or not".

No report on method used to blind both the participants and personnel

Blinding of outcome as-

sessment (detection bias)

All outcomes

Unclear risk No information was given on how knowledge of allocated interventions was

prevented during measurement of outcomes.

Incomplete outcome data

(attrition bias)

All outcomes

Unclear risk No information was provided on the flow of participants.

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Selective reporting (re-

porting bias)

Low risk No published protocol available, but the prespecified outcomes were ad-

dressed adequately.

Prespecified outcomes

1. Number of days before 1st spontaneous bowel movement

2. Number of capsules (laxative) taken before 1st spontaneous bowel move-

ment

3. Number of postpartum enemas given

Other bias Unclear risk Ethics approval not stated

Purdue Fredrick Co. supplied the laxative (Senokap) used for the trial

Conflict of interest was not addressed; we are not sure if there was a conflict of

interest

Zuspan 1960(Continued)

RCT: randomised controlled trial



Characteristics of excluded studies [ordered by study ID]



Study Reason for exclusion

ChiCTR1900023067 Trial did not study interventions for preventing postpartum constipation.

Liu 2009 Trial did not study interventions to prevent postpartum constipation.

Mahony 2004 Trial did not study interventions to prevent postpartum constipation.

Sakai 2015 Included participants already had symptoms of constipation.



Characteristics of ongoing studies [ordered by study ID]



Study name The effect of Kegel exercises for prevention and treatment of constipation and flatulence in antena-

tal and postnatal

Methods Randomised controlled trial

Participants Pregnant mothers, healthy. Minimum age 18 years old

Interventions Experimental group: Kegel exercises on daily basis, 3 times a day, for 15 to 20 minutes, for 8 consec-

utive weeks, in addition to routine care

Control group: conventional standard methods for improving constipation, such as increased fluid

and fibre intake (celluloid material, such as wheat and whole wheat, wheat bran, vegetables, and

fruits)

Outcomes Constipation score; bloating score

Starting date Expected recruitment date: 21 May 2019

Contact information Saideh Mehrabadi (saidehmehrabadi@yahoo.com)

IRCT20190427043386N1

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Notes Email sent to the author, enquiring about the trial

IRCT20190427043386N1(Continued)



D A T A  A N D  A N A L Y S E S



Comparison 1.  Laxative versus placebo

Outcome or subgroup title No. of studies No. of partici-

pants

Statistical method Effect size

1.1 Number of women with first

bowel movement within 24 hours

after delivery

1 471 Risk Ratio (M-H, Fixed, 95%

CI)

2.90 [2.24, 3.75]

1.2 Number of women with first

bowel movement on day 1 after de-

livery

3  Risk Ratio (M-H, Random,

95% CI)

Totals not selected

1.3 Number of women with first

bowel movement on day 2 after de-

livery

3  Risk Ratio (M-H, Random,

95% CI)

Totals not selected

1.4 Number of women with first

bowel movement on day 3 after de-

livery

2  Risk Ratio (M-H, Random,

95% CI)

Totals not selected

1.5 Number of women with first

bowel movement on day 4 after de-

livery

2  Risk Ratio (M-H, Fixed, 95%

CI)

Totals not selected

1.6 Stool consistency - loose or wa-

tery stools

1 106 Risk Ratio (M-H, Fixed, 95%

CI)

26.96 [3.81, 191.03]

1.7 Number of postpartum enemas

given

1 244 Risk Ratio (M-H, Fixed, 95%

CI)

0.63 [0.38, 1.05]

1.8 Number of women receiving

suppositories or enemas

1 200 Risk Ratio (M-H, Fixed, 95%

CI)

0.29 [0.13, 0.65]

1.9 Number of women having 2 or

more bowel movements per day

1 106 Risk Ratio (M-H, Fixed, 95%

CI)

26.02 [1.59, 426.73]

1.10 Number of days on which a

bowel movement occurred

1  Risk Ratio (M-H, Random,

95% CI)

Subtotals only

1.10.1 Zero days 1 200 Risk Ratio (M-H, Random,

95% CI)

0.05 [0.00, 0.89]

1.10.2 One day 1 200 Risk Ratio (M-H, Random,

95% CI)

1.12 [0.45, 2.80]

1.10.3 Two days 1 200 Risk Ratio (M-H, Random,

95% CI)

0.60 [0.39, 0.90]

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Outcome or subgroup title No. of studies No. of partici-

pants

Statistical method Effect size

1.10.4 Three days 1 200 Risk Ratio (M-H, Random,

95% CI)

1.35 [0.88, 2.06]

1.10.5 Four days 1 200 Risk Ratio (M-H, Random,

95% CI)

2.70 [1.38, 5.28]

1.10.6 Five days 1 200 Risk Ratio (M-H, Random,

95% CI)

0.80 [0.22, 2.89]

1.11 Adverse effects: women with

abdominal cramps

2  Risk Ratio (M-H, Random,

95% CI)

Totals not selected

1.12 Adverse effects on the baby 1  Risk Ratio (M-H, Fixed, 95%

CI)

Subtotals only

1.12.1 Loose stools 1 281 Risk Ratio (M-H, Fixed, 95%

CI)

0.62 [0.16, 2.41]

1.12.2 Diarrhoea 1 281 Risk Ratio (M-H, Fixed, 95%

CI)

2.46 [0.23, 26.82]



Analysis 1.1.  Comparison 1: Laxative versus placebo, Outcome 1: Number

of women with first bowel movement within 24 hours aer delivery

Study or Subgroup

Shelton 1980 (1)

Total (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 8.15 (P < 0.00001)

Test for subgroup differences: Not applicable

Laxative

Events

142

Total

224

Placebo

Events

Total

247

Weight

100.0%

Risk Ratio

M-H, Fixed, 95% CI

2.90 [2.24 , 3.75]

Risk Ratio

M-H, Fixed, 95% CI

0.05 0.2 1 5 20

Favours placebo Favours laxative

Footnotes

(1) Laxative used: active senna

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Analysis 1.2.  Comparison 1: Laxative versus placebo, Outcome 2:

Number of women with first bowel movement on day 1 aer delivery

Study or Subgroup

Diamond 1968 (1)

Mundow 1975 (2)

Shelton 1980 (3)

Laxative

Events

Total

100

224

Placebo

Events

Total

100

247

Risk Ratio

M-H, Random, 95% CI

2.01 [1.09 , 3.70]

0.78 [0.30 , 2.01]

0.94 [0.72 , 1.22]

Risk Ratio

M-H, Random, 95% CI

0.005 0.1 1 10 200

Favours placebo Favours laxativeFootnotes

(1) Laxative used: Bisoxatin acetate (no longer recommended for breastfeeding women)

(2) Laxative used: Dorbanex (Danthron; found to be carcinogenic in animals and no longer marketed)

(3) Laxative used: active senna.



Analysis 1.3.  Comparison 1: Laxative versus placebo, Outcome 3:

Number of women with first bowel movement on day 2 aer delivery

Study or Subgroup

Diamond 1968 (1)

Mundow 1975 (2)

Shelton 1980 (3)

Laxative

Events

Total

100

224

Placebo

Events

Total

100

247

Risk Ratio

M-H, Random, 95% CI

2.78 [1.44 , 5.36]

4.08 [2.32 , 7.20]

0.23 [0.11 , 0.45]

Risk Ratio

M-H, Random, 95% CI

0.005 0.1 1 10 200

Favours placebo Favours laxativeFootnotes

(1) Laxative used: Bisoxatin acetate (no longer recommended for breastfeeding women)

(2) Laxative used: Dorbanex (Danthron; found to be carcinogenic in animals and no longer marketed)

(3) Laxative used: active senna.



Analysis 1.4.  Comparison 1: Laxative versus placebo, Outcome 4:

Number of women with first bowel movement on day 3 aer delivery

Study or Subgroup

Mundow 1975 (1)

Shelton 1980 (2)

Laxative

Events

Total

100

224

Placebo

Events

Total

100

247

Risk Ratio

M-H, Random, 95% CI

0.91 [0.60 , 1.37]

0.05 [0.00 , 0.89]

Risk Ratio

M-H, Random, 95% CI

0.002 0.1 1 10 500

Favours placebo Favours laxativeFootnotes

(1) Laxative used: Dorbanex (Danthron; found to be carcinogenic in animals and no longer marketed)

(2) Laxative used: active senna

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Analysis 1.5.  Comparison 1: Laxative versus placebo, Outcome 5:

Number of women with first bowel movement on day 4 aer delivery

Study or Subgroup

Mundow 1975 (1)

Shelton 1980 (2)

Laxative

Events

Total

100

224

Placebo

Events

Total

100

247

Risk Ratio

M-H, Fixed, 95% CI

0.37 [0.21 , 0.64]

0.22 [0.03 , 1.87]

Risk Ratio

M-H, Fixed, 95% CI

0.005 0.1 1 10 200

Favours placebo Favours laxativeFootnotes

(1) Laxative used: Dorbanex (Danthron; found to be carcinogenic in animals and no longer marketed)

(2) Laxative used: active senna



Analysis 1.6.  Comparison 1: Laxative versus placebo, Outcome 6: Stool consistency - loose or watery stools

Study or Subgroup

Diamond 1968 (1)

Total (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 3.30 (P = 0.0010)

Test for subgroup differences: Not applicable

Laxative

Events

Total

Placebo

Events

Total

Weight

100.0%

Risk Ratio

M-H, Fixed, 95% CI

26.96 [3.81 , 191.03]

Risk Ratio

M-H, Fixed, 95% CI

0.005 0.1 1 10 200

Favours placebo Favours laxative

Footnotes

(1) Laxative used: Bisoxatin acetate (no longer recommended for breastfeeding women)



Analysis 1.7.  Comparison 1: Laxative versus placebo, Outcome 7: Number of postpartum enemas given

Study or Subgroup

Zuspan 1960

Total (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 1.77 (P = 0.08)

Test for subgroup differences: Not applicable

Laxative

Events

Total

123

Placebo

Events

Total

121

Weight

100.0%

Risk Ratio

M-H, Fixed, 95% CI

0.63 [0.38 , 1.05]

Risk Ratio

M-H, Fixed, 95% CI

0.1 0.2 0.5 1 2 5 10

Favours laxative Favours placebo

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Analysis 1.8.  Comparison 1: Laxative versus placebo, Outcome

8: Number of women receiving suppositories or enemas

Study or Subgroup

Mundow 1975 (1)

Total (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 3.04 (P = 0.002)

Test for subgroup differences: Not applicable

Laxative

Events

Total

100

Placebo

Events

Total

100

Weight

100.0%

Risk Ratio

M-H, Fixed, 95% CI

0.29 [0.13 , 0.65]

Risk Ratio

M-H, Fixed, 95% CI

0.01 0.1 1 10 100

Favours laxative Favours placebo

Footnotes

(1) Laxative used: Dorbanex (Danthron; found to be carcinogenic in animals and no longer marketed)



Analysis 1.9.  Comparison 1: Laxative versus placebo, Outcome

9: Number of women having 2 or more bowel movements per day

Study or Subgroup

Diamond 1968 (1)

Total (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 2.28 (P = 0.02)

Test for subgroup differences: Not applicable

Laxative

Events

Total

Placebo

Events

Total

Weight

100.0%

Risk Ratio

M-H, Fixed, 95% CI

26.02 [1.59 , 426.73]

Risk Ratio

M-H, Fixed, 95% CI

0.002 0.1 1 10 500

Favours placebo Favours laxative

Footnotes

(1) Laxative used: Bisoxatin acetate (no longer recommended for breastfeeding women)

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Analysis 1.10.  Comparison 1: Laxative versus placebo, Outcome

10: Number of days on which a bowel movement occurred

Study or Subgroup

1.10.1 Zero days

Mundow 1975 (1)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 2.04 (P = 0.04)

1.10.2 One day

Mundow 1975 (1)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 0.25 (P = 0.80)

1.10.3 Two days

Mundow 1975 (1)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 2.48 (P = 0.01)

1.10.4 Three days

Mundow 1975 (1)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 1.37 (P = 0.17)

1.10.5 Four days

Mundow 1975 (1)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 2.90 (P = 0.004)

1.10.6 Five days

Mundow 1975 (1)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 0.34 (P = 0.73)

Test for subgroup differences: Chi² = 20.75, df = 5 (P = 0.0009), I² = 75.9%

Laxative

Events

Total

100

Placebo

Events

Total

100

Weight

100.0%

Risk Ratio

M-H, Random, 95% CI

0.05 [0.00 , 0.89]

1.13 [0.45 , 2.80]

0.60 [0.39 , 0.90]

1.35 [0.88 , 2.06]

2.70 [1.38 , 5.28]

0.80 [0.22 , 2.89]

Risk Ratio

M-H, Random, 95% CI

0.2 0.5 1 2 5

Favours placebo Favours laxative

Footnotes

(1) Laxative used: Dorbanex (Danthron; found to be carcinogenic in animals and no longer marketed)

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Analysis 1.11.  Comparison 1: Laxative versus placebo, Outcome 11: Adverse eects: women with abdominal cramps

Study or Subgroup

Mundow 1975 (1)

Shelton 1980 (2)

Laxative

Events

Total

100

224

Placebo

Events

Total

100

247

Risk Ratio

M-H, Random, 95% CI

0.25 [0.03 , 2.20]

4.23 [1.75 , 10.19]

Risk Ratio

M-H, Random, 95% CI

0.01 0.1 1 10 100

Favours laxative Favours placeboFootnotes

(1) Laxative used: Dorbanex (Danthron; found to be carcinogenic in animals and no longer marketed)

(2) Laxative used: active senna



Analysis 1.12.  Comparison 1: Laxative versus placebo, Outcome 12: Adverse eects on the baby

Study or Subgroup

1.12.1 Loose stools

Shelton 1980 (1)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 0.70 (P = 0.49)

1.12.2 Diarrhoea

Shelton 1980 (2)

Subtotal (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 0.74 (P = 0.46)

Test for subgroup differences: Chi² = 0.97, df = 1 (P = 0.32), I² = 0%

Laxative

Events

Total

126

Placebo

Events

Total

155

Weight

100.0%

Risk Ratio

M-H, Fixed, 95% CI

0.62 [0.16 , 2.41]

2.46 [0.23 , 26.82]

Risk Ratio

M-H, Fixed, 95% CI

0.01 0.1 1 10 100

Favours laxative Favours placebo

Footnotes

(1) Laxative used: active senna

(2) Laxative used: Active Senna



Comparison 2.  Laxative plus bulking agent versus laxative alone

Outcome or subgroup title No. of studies No. of partici-

pants

Statistical method Effect size

2.1 Faecal incontinence during first 10

postpartum days

1 147 Risk Ratio (M-H, Fixed,

95% CI)

1.81 [1.01, 3.23]



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Analysis 2.1.  Comparison 2: Laxative plus bulking agent versus laxative

alone, Outcome 1: Faecal incontinence during first 10 postpartum days

Study or Subgroup

Eogan 2007

Total (95% CI)

Total events:

Heterogeneity: Not applicable

Test for overall effect: Z = 2.00 (P = 0.05)

Test for subgroup differences: Not applicable

Laxative + bulking agent

Events

Total

Laxative alone

Events

Total

Weight

100.0%

Risk Ratio

M-H, Fixed, 95% CI

1.81 [1.01 , 3.23]

Risk Ratio

M-H, Fixed, 95% CI

0.01 0.1 1 10 100

Favours laxative alone Favours laxative + bulking



A P P E N D I C E S

Appendix 1. Rome IV diagnostic criteria for functional constipation



Criteria Must include 2 or more of the following:

1a Straining during more than one-fourth (25%) of defecations

1b Lumpy or hard stools (Bristol Stool Form Scale, 1 to 2) more than defecations

1c Sensation of incomplete evacuation more than one-fourth (25%) of defecations

1d Sensation of anorectal obstruction or blockage more than one-fourth (25%) of defecations

1e Manual maneuvers to facilitate more than one fourth (25%) of defecations (e.g. digital evacuation,

support of the pelvic floor)

1f Fewer than 3 spontaneous bowel movements per week

2. Loose stools are rarely present without the use of laxatives

3. Insufficient criteria for irritable bowel syndrome

Note: criteria must be met for the last three months, with symptom onset at least six months prior to diagnosis



Appendix 2. Bristol Stool Form Scale



Type Description of stools

1 Separate hard lumps, like nuts (difficult to pass)

2 Sausage-shaped, but lumpy

3 Like a sausage, but with cracks on its surface

4 Like a sausage or snake, smooth and so



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5 So blobs with clear-cut edges (passed easily)

6 Fluy pieces with ragged edges, a mushy stool

7 Watery, no solid pieces, entirely liquid

(Continued)



Appendix 3. Search strategy for ICTRP and ClinicalTrials.gov

ICTRP

(searched using all synonyms)

postpartum AND constipation

ClinicalTrials.gov

Advanced search

postpartum | Interventional Studies | Constipation

W H A T ' S  N E W



Date Event Description

7 October 2019 New search has been performed Search was updated, but none of the identified trials met the in-

clusion criteria. We updated the various sections of the review

using MECIR standards. We added time to first bowel movement

to the primary outcomes. We used GRADEpro GDT to assess the

quality of evidence by evaluating risk of bias, inconsistency, im-

precision, indirectness, and publication bias. We added a 'Sum-

mary of findings' table indicating the level and reasons for down-

grading.

We removed data for two studies from the data and analysis ta-

bles for the comparison of laxative versus placebo. One study as-

sessed the effects of Danthron (a laxative that is no longer mar-

keted due to carcinogenic properties (Mundow 1975)), and the

other study investigated the effects of Bisoxatin acetate (a laxa-

tive that is not recommended for using during breastfeeding (Di-

amond 1968)). Whilst the data have been removed from the data

and analysis tables, we provide a narrative report of the results

of those studies in the main results of the review.

7 October 2019 New citation required but conclusions

have not changed

Search updated. No new trials included in this update. Conclu-

sions remain unchanged.



H I S T O R Y

Protocol first published: Issue 3, 2015

Review first published: Issue 9, 2015

C O N T R I B U T I O N S  O F  A U T H O R S

A Rohwer (AR), E Turawa (ET), and A Musekiwa (AM) conceptualised the question. ET and AM draed the review. AR provided overall

guidance, critically engaged with the dra and provided comments. All authors have seen and approved the final version of the review.

ET is guarantor of this review.

Interventions for preventing postpartum constipation (Review)

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D E C L A R A T I O N S  O F  I N T E R E S T

Eunice B Turawa: is partly supported by the Research, Evidence and Development Initiative (READ-It) project (project number 300342-104).

READ-It is funded by aid from the UK government; however, the views expressed do not necessarily reflect the UK government’s oicial

policies.

Alfred Musekiwa: is partly supported by the Research, Evidence and Development Initiative (READ-It) project (project number 300342-104).

READ-It is funded by aid from the UK government; however, the views expressed do not necessarily reflect the UK government’s oicial

policies.

Anke C Rohwer: is partly supported by the Research, Evidence and Development Initiative (READ-It) project (project number 300342-104).

READ-It is funded by aid from the UK government; however, the views expressed do not necessarily reflect the UK government’s oicial

policies. This DFID grant aimed at ensuring the best possible systematic reviews, particularly Cochrane Reviews, are completed on topics

relevant to the poor, particularly women, in low- and middle-income countries. DFID does not participate in the selection of topics, in the

conduct of the review, or in the interpretation of findings.

S O U R C E S  O F  S U P P O R T

Internal sources

•Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Faculty of Medicine and Health Sciences,

Stellenbosch University, South Africa

External sources

•National Institute for Health Research (NIHR) Cochrane Review Incentive Scheme award, UK

Award number 14/175/47

•Research, Evidence and Development Initiative (READ-It) project, UK

D I F F E R E N C E S  B E T W E E N  P R O T O C O L  A N D  R E V I E W

We added the primary outcome 'time to first bowel movement', we assessed the certainty of evidence with GRADE, and added a 'Summary

of findings" table. This was not one of the prespecified outcomes in our protocol (Turawa 2015a).

I N D E X  T E R M S

Medical Subject Headings (MeSH)

Constipation [*prevention & control]; Defecation; Dietary Fiber [adverse eects] [*therapeutic use]; Laxatives [adverse eects]

[*therapeutic use]; Perineum [injuries]; Postpartum Period; Puerperal Disorders [*prevention & control]; Randomized Controlled

Trials as Topic; Time Factors

MeSH check words

Adult; Female; Humans

Interventions for preventing postpartum constipation (Review)

ResearchGate has not been able to resolve any citations for this publication.

Long-term postpartum health problems in Turkish women: prevalence and associations with self-rated health

Article

Full-text available

Nov 2016
CONTEMP NURSE

Objective: To examine the frequency of physical and emotional health problems associated with labor and their relationship with self-rated health measures. Methods: Four hundred women were enrolled. Data collection was accomplished through the completion of a form on sociodemographic and obstetric characteristics, a questionnaire that measured the self-rated health level as well as physical health problems, and Edinburgh Postpartum Depression Scale (EPDS). Results: Most commonly reported health problems in the initial 6-week period were fatigue (77.5%), sleep disturbance (76.0%) and dysuria (61.3%). At 1-year post-partum, fatigue (33.9%), sleep disturbance (32.8%), and constipation (15.5%) were the most commonly reported complaints. Those who self-reported a "poor health" at 6 weeks and 1 year comprised of 40.0% and 19.8% of the participants, respectively. Conclusion: Further studies in other populations are warranted to better delineate the prevalence rates, which will provide useful data for developing policies aimed at improving postpartum care.

The Pathophysiology of Chronic Constipation

Article

Full-text available

Oct 2011
CAN J GASTROENTEROL

Constipation is broadly defined as an unsatisfactory defecation characterized by infrequent stools, difficult stool passage or both. The common approach to the pathophysiology of constipation groups the disorder into primary and secondary causes. Primary causes are intrinsic problems of colonic or anorectal function, whereas secondary causes are related to organic disease, systemic disease or medications. The normal process of colonic transit and defecation is discussed, and the etiology of constipation is reviewed.

The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration

Article

Full-text available

Aug 2009

Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

Interventions for preventing postpartum constipation

Article

Mar 2015

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effectiveness and safety of interventions for preventing postpartum constipation.

Cochrane Handbook for Systematic Reviews of Interventions

Book

Jan 2011

Health after childbirth: Patterns of reported postpartum morbidity from Lebanon

Article

Mar 2013

Problem and background: The postpartum period is under-researched in low and middle income countries. The scarce literature reveals heavy burden of ill health experienced in that period and under utilisation of health services. Understanding the postpartum morbidity burden and identifying the care-seeking behaviours is essential to improve service delivery. Question: This paper examines reported postpartum morbidity, care seeking behaviour and whether postpartum morbidity is associated with method of birth. Methods: A cross sectional study of women delivering in 18 private hospitals from two regions in Lebanon was undertaken. Women in their second or third trimester of pregnancy, visiting private obstetric clinics affiliated with participating hospitals were interviewed for baseline information. Reported postpartum morbidity was assessed in an interview conducted at women's homes from 40 days up to six months postpartum. Findings: Of the 269 women recruited, physical postpartum health problems were reported by 93.6% and psychological health problems by 84.4% of women, with more health problems being reported beyond two months postpartum. Women were less likely to seek professional care for psychological health problems. Reporting postpartum health problems was not associated with method of birth. Conclusion: A heavy burden of postpartum morbidity is experienced by women with gaps in utilisation of relevant health services. Efforts should be directed towards the organisation and delivery of comprehensive maternity care services.

Danthron/Poloxalkol and Placebo in Puerperal Constipation

Article

May 1975
Br J Clin Pract

L. S. Mundow

Bisoxatin acetate as a postpartum oral laxative: a random double blind controlled experiment in 106 subjects

Article

Feb 1968
J Lancet

Stool Form Scale as a Useful Guide to Intestinal Transit Time

Article

Sep 1997

Stool form scales are a simple method of assessing intestinal transit rate but are not widely used in clinical practice or research, possibly because of the lack of evidence that they are responsive to changes in transit time. We set out to assess the responsiveness of the Bristol stool form scale to change in transit time. Sixty-six volunteers had their whole-gut transit time (WGTT) measured with radiopaque marker pellets and their stools weighed, and they kept a diary of their stool form on a 7-point scale and of their defecatory frequency. WGTT was then altered with senna and loperamide, and the measurements were repeated. The base-line WGTT measurements correlated with defecatory frequency (r = 0.35, P = 0.005) and with stool output (r = -0.41, P = 0.001) but best with stool form (r = -0.54, P < 0.001). When the volunteers took senna (n = 44), the WGTT decreased, whereas defecatory frequency, stool form score, and stool output increased (all, P < 0.001). With loperamide (n = 43) all measurements changed in the opposite direction. Change in WGTT from base line correlated with change in defecatory frequency (r = 0.41, P < 0.001) and with change in stool output (n = -0.54, P < 0.001) but best with change in stool form (r = -0.65, P < 0.001). This study has shown that a stool form scale can be used to monitor change in intestinal function. Such scales have utility in both clinical practice and research.

Epidemiology of Constipation in North America: A Systematic Review

Article

May 2004

The aim of this study was to systematically review the published literature regarding prevalence, risk factors, incidence, natural history, and the effect on quality of life of constipation in North America. A computer-assisted search of MEDLINE, EMBASE, and Current Contents databases was performed independently by two investigators. Study selection criteria included the following: (1) North American population-based sample of adults with constipation; (2) publication in full manuscript form in English; and (3) report on the prevalence, incidence, and natural history of constipation or impact of constipation on quality of life. Eligible articles were reviewed in a duplicate, independent manner. Data extracted were compiled in tables and presented in descriptive form. The estimates of the prevalence of constipation in North America ranged from 1.9% to 27.2%, with most estimates from 12% to 19%. Prevalence estimates by gender support a female-to-male ratio of 2.2:1. Constipation appears to increase with increasing age, particularly after age 65. No true population-based incidence studies or natural history studies were identified. In one cohort, 89% of patients with constipation still reported constipation at 14.7 months follow-up. From limited data, quality of life appears to be diminished by constipation, but the clinical significance of this is unclear. Constipation is very common, as approximately 63 million people in North America meet the Rome II criteria for constipation. Minimal data are available regarding incidence, natural history, and quality of life in patients with constipation. Effort should be expended toward the study of these topics, particularly in the elderly, who are disproportionately affected by this condition.

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