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Uterine massage to reduce postpartum hemorrhage after vaginal delivery
Abstract
To determine the effectiveness of sustained uterine massage started before delivery of the placenta in reducing postpartum hemorrhage.
A randomized controlled trial conducted in Egypt and South Africa between September 2006 and February 2009. A total of 1964 pregnant women were randomly allocated to 1 of 3 treatment groups: intramuscular oxytocin, sustained uterine massage, or both treatments. Blood loss within 30 minutes of delivery was recorded.
The incidence of blood loss of 300 mL or more within 30 minutes of delivery was significantly higher in the massage group than in the massage plus oxytocin (RR 1.88; 95% CI, 1.29-2.74 in Assiut, and RR 1.3; 95% CI, 1.00-1.68 in SA) and the oxytocin only group (RR 1.7; 95% CI, 1.11-2.61 in Assiut, and RR 2.24; 95% CI, 1.54-3.27 in SA). In both centers, use of additional uterotonics was significantly higher in the uterine massage group compared with the other 2 groups.
Uterine massage was less effective than oxytocin for reducing blood loss after delivery. When oxytocin was used, there was no additional benefit from uterine massage. The effectiveness of uterine massage in the absence of oxytocin was not studied. ACTRN: 12609000372280.
... PPH is the main cause of maternal mortality and severe morbidity, especially in countries with inadequate health services [2]. In countries with good quality health care, deaths from postpartum hemorrhage are extremely rare because effective preventive methods are available [3]. Therefore, it is of serious importance to investigate simple measures that can be universally applied at the community level to reduce the incidence of PPH. ...
... However, there are few experimental researches which evaluate the effectiveness of this method. Randomized controlled trials have reported conflicting results regarding the efficacy of uterine massage for the prevention of PPH after vaginal delivery [3,4,12]. The aim of this study was to demonstrate the efficacy of uterine massage initiated before delivery of the placenta in reducing PPH. ...
... The results of our study show that routine uterine massage after vaginal delivery shortens the third stage of labor and the placenta emerges in a significantly shorter time. Abdel-Aleem et al. evaluated the effects of uterine massage performed before placenta expulsion [3]. This study showed that uterine massage alone was associated with greater blood loss 30 min after delivery compared to treatment with oxytocin with or without massage. ...
Objective
The aim of this study was to investigate the effects of uterine massage performed before placental delivery on the third stage of labor and postpartum hemorrhage after vaginal delivery.
Materials and methods
The study was designed as a prospective randomized controlled study. Between June 2018 and June 2019, 242 women who gave birth in Istanbul Kanuni Sultan Suleyman Training and Research Hospital were included in the study. The women were divided into two groups; group 1 received uterine massage after vaginal delivery before placental delivery (n: 128) and group 2 did not receive massage (n: 114). Demographic characteristics, delivery times of the baby and placenta, duration of uterine massage, amount of postpartum hemorrhage and postpartum hemoglobin values of both groups were recorded.
Results
Baseline characteristics were similar in both groups. Placental output time after delivery was 8.3 ± 4.2 min in group 1 and 13.5 ± 6.3 min in group 2. The third stage of labor was significantly shorter in group 1 (p = 0.012). The amount of blood loss of 500 mL or more after delivery was higher in group 2 but not statistically different (p > 0.05). Hemoglobin value measured within 12–24 h after delivery was significantly lower in group 2 (hemoglobin < 8 g/dL after 12–24 h p = 0.003; hemoglobin < 10 g/dL after 12–24 h p = 0.001). Delta hb value was also significantly lower in group 2 (p = 0.03). With this result, it was determined that bleeding intense enough to require transfusion was more common in group 2.
Conclusion
In patients delivering vaginally, uterine massage before placental delivery shortens the placental delivery time and reduces postpartum hemorrhage. In addition to oxytocin and controlled cord traction to reduce postpartum blood loss, uterine massage should be routinely used in the active management of the third stage of labor.
Clinical trials number: NCT03858569.
... Two randomized controlled trial assessed the effectiveness of uterine massage for preventing postpartum hemorrhage after vaginal delivery with conflicting results. [12,13] The result was inclusive because one trial was limited to small size and in other trial, uterine massage applied before rather than after delivery of the placenta. Chen M, Chan Q, Duan T, He J, Zhang L, Liu X [14] performed a multicentre randomized controlled trial to estimate the effectiveness of sustained transabdominal uterine massage, after delivery of the placenta in reducing blood loss after vaginal delivery that indicated no need for routine uterine massage to reduce amount of blood loss. ...
... However, this study included 200 samples but the study was underpowered to detect a difference in blood loss over 500 ml between two groups. So, Abdel-Aleem H, Singata M, Abdel-Aleem M, Mshweshwe N et.al [13] conducted another randomized controlled trial in Egypt and South Africa with 1,964 samples which suggested that uterine massage was inferior to oxytocin in reducing blood loss after delivery (RR 1.56,95% CI 0.44, 5.49) and it did not bring any additional benefit when prophylactic oxytocin was used (RR 1.02, 95% CI 0.56 to 1.85). The findings of present study are partly similar with the latter trial [13] and only the difference was timing of initiation of uterine massage. ...
... So, Abdel-Aleem H, Singata M, Abdel-Aleem M, Mshweshwe N et.al [13] conducted another randomized controlled trial in Egypt and South Africa with 1,964 samples which suggested that uterine massage was inferior to oxytocin in reducing blood loss after delivery (RR 1.56,95% CI 0.44, 5.49) and it did not bring any additional benefit when prophylactic oxytocin was used (RR 1.02, 95% CI 0.56 to 1.85). The findings of present study are partly similar with the latter trial [13] and only the difference was timing of initiation of uterine massage. Here, uterine massage was initiated after delivery of the placenta according to international guidelines, whereas in the previous trial massage applied before delivery of placenta. ...
The most common cause of maternal death worldwide is postpartum hemorrhage (PPH) and Active Management of Third Stage of Labour (AMTSL) is the most important prophylactic intervention for prevention of PPH. A study was undertaken to assess the effect of AMTSL with and without uterine massage on maternal outcome among postnatal mothers in a selected hospital, WB. In this quasi-experimental study, Total 60 (Experimental Group-30, Control Group-30) postnatal mothers who undergone spontaneous vaginal delivery were selected by non-probability purposive sampling technique followed by randomization. The uterine massage is applied for 1 min immediately after placental delivery to 2 hours of postpartum at every 15 mins interval. The results revealed that there was no statistically significant difference of mean amount of postpartum bleeding between experimental and control group at 1st hour, 2nd hour, 24 hours, and 48 hours [t1= 1.06, t2= 1.52, t3=0.47, t4=0.26 at df (58), p>0.05]. The general condition (BP, Pulse, Respiration) after 1st hour, 2nd hour, 24 hours and 48 hours were comparable and statistically not significant between the two groups. There was no significant association between amount of postpartum bleeding and obstetrical parameters like parity, gravida, POG, presence of episiotomy, birth weight, time of placental delivery, presence of tear and time of initiation of breast feeding etc. for both groups. Based on the results of the current study, it can be concluded that the mothers who received the uterine massage along with AMTSL get no additional benefit as compared to control group. Keywords: Active management of third stage of labour (AMTSL); Uterine massage; Maternal outcome; Postnatal mother.
... Hence, there is a need for simple, inexpensive techniques that can be applied in low-resourced settings to prevent and treat PPH (Abdel-Aleem et al., 2010;Chen et al., 2013). Whether uterine massage is effective in reducing PPH is still controversial. ...
... According to the WHO data, the prevalence of anemia among pregnant women was reported as 56% in developing countries, 18% in developed countries, and 40.2% in Turkey (WHO/CDC, 2008). Considering that more than half of the countries in the world are undeveloped and developing countries (Juddin & Hamadeh 2020), that anemia and PPH deaths are high in these places, and that access to hospitals or uterotonics is limited or non-existent, it is stated that uterine massage, which can be performed under any conditions, is a life-saver as it is a simple application that has low cost, is effective, and does not require any tools (Abdel-Aleem et al., 2010, Ildan Çalım & Kavlak, 2014Saccone et al., 2018). However, very little empirical research has been performed to evaluate the effectiveness of this method (Abdel-Aleem et al., 2010). ...
... Considering that more than half of the countries in the world are undeveloped and developing countries (Juddin & Hamadeh 2020), that anemia and PPH deaths are high in these places, and that access to hospitals or uterotonics is limited or non-existent, it is stated that uterine massage, which can be performed under any conditions, is a life-saver as it is a simple application that has low cost, is effective, and does not require any tools (Abdel-Aleem et al., 2010, Ildan Çalım & Kavlak, 2014Saccone et al., 2018). However, very little empirical research has been performed to evaluate the effectiveness of this method (Abdel-Aleem et al., 2010). ...
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and disability. A need for simple, inexpensive techniques to prevent PPH and provide treatment exists, particularly in cases where uterotonics cannot be accessed. Uterine massage is recommended as part of the routine active management of the third stage of labor. This study was conducted to determine the effectiveness of uterine massage after delivery of the placenta in reducing postpartum blood loss. Thus, a randomized controlled trial was conducted in Turkey between March 2018 and September 2018. A total of 176 pregnant women (88 in the control and 88 in the uterine massage groups) were randomly allocated to the two groups: one group receiving sustained uterine massage, while the other comprising the control group. The uterine massage group was administered transabdominal uterine massage, starting immediately after delivery of the placenta and continuing every 15 min for a duration of 2 h until the uterus hardened. The blood loss within 2 h of delivery was recorded. Level of significance was taken as p < 0.05, and the chi-square, t, and Mann–Whitney U tests as well as Spearman’s correlation and linear regression were employed in the analysis of the data. The average amount blood loss within 2 h of the delivery was significantly higher in the control group than in the massage group (X = 170.49 ± 61.46 and X = 186.20 ± 47.59, p < 0.05). A statistically significant difference was present between the uterine massage and control groups in terms of hemoglobin, hematocrit, WBC, and RCB pre-delivery and pre-discharge (first 24 h) values and in the use of additional uterotonics and the amount of blood loss (p < 0.05). The results of the analysis show that postpartum uterine massage has a reducing effect on the amount of PPH.
... Three RCTs, including 3,842 singleton gestations, comparing uterine massage, in addition to oxytocin and controlled cord traction, versus no uterine massage, were found. [9][10][11] Statistical heterogeneity within the studies was high with I 2 =73% for the primary outcome. Additional unpublished data from two trials were kindly obtained by the original authors. ...
... Additional unpublished data from two trials were kindly obtained by the original authors. 9,10 The quality of the three included trials in general was low and all of them had high or unclear risk of bias in most of the seven Cochrane domains related to the risk of bias ( Figure S2A and Figure S2B). ...
... One trial was a three arm RCT. 10 In this trial, women were randomized into 1:1:1 ratio in one of the following group: oxytocin and controlled cord traction, uterine massage only, oxytocin and controlled cord traction and uterine massage. For this review, the "uterine massage only" group was excluded. ...
The first cause of maternal death worldwide is postpartum hemorrhage (PPH), responsible for an estimated 127,000 deaths annually. Failure of the uterus to contract adequately after childbirth is the most common cause of PPH. In the absence of timely and appropriate action, a woman could die within a few hours. This article is protected by copyright. All rights reserved.
... Oxytocin is almost universally accepted as the first-line agent in the management and preven-tion of abnormal uterine tone after cesarean and vaginal delivery [4]. Many studies have shown that oxytocin is associated with a substantial reduction in PPH, blood transfusion and the use of additional uterotonics [5][6][7][8]. Meanwhile, a number of trials and observational studies have shown that the side-effects of oxytocin include nausea, vomiting, headache, and hemodynamic instability [9][10][11][12]. ...
... These could result in a bias of reported incidence rates in the clinical trials. Third, side-effects were reported, but no data were provided in two trials [5,81], and we excluded them in these studies. Although no publication bias was found, this could increase the publication bias risk. ...
Objective:
To evaluate the side-effects of oxytocin for the prevention of postpartum hemorrhage (PPH) in randomized controlled trials (RCTs).
Methods:
Electronic databases (Web of Science, Embase, PubMed, Elsevier ScienceDirect, the Cochrane Library, and ClinicalTrials.gov) were searched from the beginning of indexing to Sep 2021. RCTs comparing oxytocin with non-oxytocin uterotonic agent(s) or non-pharmacologic interventions for the prevention of PPH were eligible.
Results:
Overall, sixty-one RCTs meeting the inclusion criteria were included, involving 68834 participants. Twenty-seven types of side-effects were reported in this study. There were 24, 35, or 2 trials assessed as high medium and low quality, respectively. Compared with non-oxytocin, oxytocin had significantly lower risk for shivering (RR=0.31, 95% CI=0.23-0.41, n=36680), fever (RR=0.27, 95% CI=0.20-0.37, n=34031), and diarrhea (RR=0.48, 95% CI=0.35-0.66, n=30883). Other side-effects were not found associated with oxytocin.
Conclusion:
Oxytocin use was association with a significantly lower incidence of shivering, fever, and diarrhea events and did not increase risk of other side-effects during the third stage of labor. These observations may aid obstetricians and gynecologists in weighing up the benefits and risks associated with oxytocin in prevention and treatment of PPH during the third stage of labor.
... In the study by Chen et al., one group received uterine massage together with oxytocin, the other group received only uterine massage, and no difference was found between the groups in terms of blood loss in the first 2 hours after delivery (20). In another study, intramuscular oxytocin, continuous uterine massage and both methods together were applied, and uterine massage was reported to be less effective than oxytocin in reducing postpartum hemorrhage (21). Chantrapitak compared lower uterine segment compression and non-compression applied groups, and lower blood loss was found in the women who were administered lower uterine segment compression (14). ...
... No statistically significant difference was found between the groups in terms of the amount of lochia at the 6 th postpartum hour (g) ( Table 3). Abdel-Aleem et al. arrived at significant results showing that uterine massage performed at the third stage of labor reduces hemorrhage in 30 minutes and 60 minutes (21). However, in this study, no difference was found between the uterine massage groups and the control group in terms of the amount of lochia. ...
Objective: The aim of this study was to determine the effects of three different methods in reducing primary postpartum hemorrhage.Methods: The study was carried out in Istanbul/Turkey with 150 people at a maternity hospital. The participants were assigned to the external circular fundus massage (ECFM) (n=50), external bimanual fundus compression (EBFC) (n=50) and control (C) (n=50) groups with the simple randomization method. The women in the experiment groups of external circular fundus massage or external bimanual uterus fundus compression received intervention for one hour in the postpartum period. At the 6th postpartum hour, the hemogram values and total lochia amount of all women were measured.Results: The mean ± standard deviation (SD) age of the women was 24.77±4.40 years, 63.3% were having their first birth, and 47.3% gained weight between 11 and 16 kg in their pregnancy. There was no significant difference between the groups in terms of the mean ± SD Hb at the 6th postpartum hour (ECFM group=11.5±1.1; EBFC Group =11.7±3.6; C group =11.4±1.0 g /dL, F= 0.371, p = 0.691). In comparison to the ECFM and C groups, the 2nd postpartum hour visual analog scale (VAS) score of the EBFC group was found to be significantly lower (p<0.05).Conclusion: The hemoglobin and thrombocyte levels at the 6th postpartum hour were higher in the EBFC group in comparison to the other groups, while the hematocrit value decreased more. Since EBFC is effective in reducing postpartum pain, it is recommended to be applied especially to women with postpartum pain.
... Massage in the backbone area can increase levels of oxytocin decreases levels of adrenocorticotropin hormone (ACTH), nitric oxide (NO) and beta-endorphin (BE). 17,18 Back massage can stimulate the release of oxytocin, which is a particular massage or pressure on the back of the neck, along with the vertebral costa 5 and 6 to the scapula in circular movements. This action will stimulate the medulla oblongata, accelerating the work of the parasympathetic nerve to send signals to the hypothalamus so that the posterior pituitary lobes produce the hormone oxytocin. ...
... The more frequent massage performed on the back, oxytocin levels will increase. 2,17,19 Massage on the back will induce oxytocin release 6---12 h after the massage. 8,20 According to the observations of researchers during the study on mothers who performed back massage had a faster involution process compared with those not massaged backs. ...
Objective
The study aimed to determine whether there is an effect of back massage on the decrease in the height of uterine fundus in primiparous normal postpartum mothers.
Methods
The subjects of 80 primiparous postpartum respondents using accidental sampling technique. Respondents were divided into two groups: the experimental group and the control group. The intervention was carried out, i.e., back massage two times a day for 15 min. Height of uterine fundus was evaluated on day 1,4,7 using an observation sheet.
Results
Mann–Whitney U statistical test obtained a p-value < 0.05, there is the effect significant of back massage to decrease the height of uterine fundus.
Conclusion
Our result confirmed that in Back massage can help increase the amount of the hormone oxytocin, which will have an impact on accelerating the decrease in the height of uterine fundus.
... Massage in the backbone area can increase levels of oxytocin decreases levels of adrenocorticotropin hormone (ACTH), nitric oxide (NO) and beta-endorphin (BE). 17,18 Back massage can stimulate the release of oxytocin, which is a particular massage or pressure on the back of the neck, along with the vertebral costa 5 and 6 to the scapula in circular movements. This action will stimulate the medulla oblongata, accelerating the work of the parasympathetic nerve to send signals to the hypothalamus so that the posterior pituitary lobes produce the hormone oxytocin. ...
... The more frequent massage performed on the back, oxytocin levels will increase. 2,17,19 Massage on the back will induce oxytocin release 6---12 h after the massage. 8,20 According to the observations of researchers during the study on mothers who performed back massage had a faster involution process compared with those not massaged backs. ...
Objective
The purpose of this study was to determine potency of back message and acupressure in increasing prolactin hormone in primiparous post-partum mothers given back massage with acupressure. Hopefully back massage and acupressure can be considered to be practiced in midwifery care.
Methods
The subjects in this study consisted of 30 primipara first day postpartum mothers who had previously performed a pretest by taking blood samples as much as 3 ccs from peripheral veins to check prolactin hormone levels using the human Enzyme-Linked Immuno-Sorbet Assay (ELISA) Kit at the Hasanuddin University Research Laboratory Makassar, then respondents were asked to fill in the table self-report containing the frequency of breastfeeding in 24 h for 3 days. The intervention was given in the form of back massage and acupressure therapy at points LU1, CV17, and SI1 on the body 1 time a day every morning with a duration of 30 min for 3 consecutive days then blood was taken on day 4, namely the median cubital vein on the anterior arm to measure the level of the prolactin hormone using ELISA KIT and compared the prolactin hormone before and after the intervention. Data were processed using paired T-tests.
Results
The treatment of back massage and acupressure in primiparous postpartum mothers had a significant effect on increasing levels of the hormone prolactin.
Conclusion
Back massage and acupressure therapy are able to increase levels of the hormone prolactin so that this therapy can be given to postpartum and breastfeeding mothers to breast milk production and can be considered practiced in midwifery care.
... Massage in the backbone area can increase levels of oxytocin decreases levels of adrenocorticotropin hormone (ACTH), nitric oxide (NO) and beta-endorphin (BE). 17,18 Back massage can stimulate the release of oxytocin, which is a particular massage or pressure on the back of the neck, along with the vertebral costa 5 and 6 to the scapula in circular movements. This action will stimulate the medulla oblongata, accelerating the work of the parasympathetic nerve to send signals to the hypothalamus so that the posterior pituitary lobes produce the hormone oxytocin. ...
... The more frequent massage performed on the back, oxytocin levels will increase. 2,17,19 Massage on the back will induce oxytocin release 6---12 h after the massage. 8,20 According to the observations of researchers during the study on mothers who performed back massage had a faster involution process compared with those not massaged backs. ...
Objective
This study was aimed to analyze the potential of acupressure for complementary therapy in postpartum women's breast milk production.
Method
It was a quasi-experimental, post-test with a control group design. The subject in this study was 80 primipara postpartum mothers. The intervention was carried in June until August 2019 at the Kadolomoko public health center area, Southeast Sulawesi. Acupressure was given within 24 h postpartum for 5 until 10 min and control group was given puerperal gymnastics, which is a standard of midwifery care. Observation of breast milk on days 2, 4, and 7 postpartum.
Results
The breast milk given by acupressure and puerperal gymnastics both increased on the second, fourth, and seventh day after delivery, but the increase in the group given acupressure was higher than in puerperal gymnastics.
Conclusion
Acupressure has the potential to be complementary care by midwives in postpartum women to help better breast milk production.
... The first was a pilot study (N = 200) in which provision of all three AMTSL interventions was associated with a non-significant decrease in the risk of post-partum hemorrhage (> 500 mL), as compared with oxytocin plus controlled cord traction [16]. In the second trial uterine massage was associated with increased blood loss, although treatment was initiated before placental delivery rather than after, as per current AMTSL guidelines [17]. ...
... In fact, our findings uniformly suggest that uterine massage either increases post-partum blood loss or confers no added benefits. This was true in both clinical regimens and is consistent with findings from prior research [17]. These findings likely reflect some selection bias, however, since uterine massage is often provided in response to heavy post-partum bleeding. ...
Active management of the third stage of labor is recommended for the prevention of post-partum hemorrhage and commonly entails prophylactic administration of a uterotonic agent, controlled cord traction, and uterine massage. While oxytocin is the first-choice uterotonic, it is not known whether its effectiveness varies by route of administration. There is also insufficient evidence regarding the value of controlled cord traction or uterine massage. This analysis assessed the independent and combined effectiveness of all three interventions, and the effect of route of oxytocin administration on post-partum blood loss.
Secondary data were analyzed from 39202 hospital-based births in four countries and two clinical regimens: one in which oxytocin was administered following delivery of the baby; the other in which it was not. We used logistic regression to examine associations between clinical and demographic variables and post-partum blood loss ≥ 700 mL.
Among those with no oxytocin prophylaxis, provision of controlled cord traction reduced hemorrhage risk by nearly 50% as compared with expectant management (P < 0.001). Among those with oxytocin prophylaxis, provision of controlled cord traction reduced hemorrhage risk by 66% when oxytocin was intramuscular (P < 0.001), but conferred no benefit when oxytocin was intravenous. Route of administration was important when oxytocin was the only intervention provided: intravenous administration reduced hemorrhage risk by 76% as compared with intramuscular administration (P < 0.001); when combined with other interventions, route of administration had no effect. In both clinical regimens, uterine massage was associated with increased hemorrhage risk.
Recommendations for active management of the third stage of labor should account for setting-related differences such as the availability of oxytocin and its route of administration. The optimal combination of interventions will vary accordingly.
... Misoprostol was associated with gastrointestinal side effects, while balloon tamponade and uterine artery embolization required skilled providers and were more invasive procedures with risks of complications. Therefore, the preventive method choice may depend on patient characteristics, clinical setting, availability of resources and expertise, and cost-effectiveness (Abdel-Aleem et al., 2010). Our logistic regression analysis showed that oxytocin use significantly predicted a lower incidence of PPH, while other variables such as age, gestational age, and delivery mode were not significant predictors. ...
Different preventive methods have been used to reduce the incidence of PPH, but their efficacy, safety, and cost-effectiveness have not been well established. We conducted a comparative study to evaluate the effectiveness, side effects, and cost of different preventive methods for PPH. 120 patients at LUMHS from 2021 to 2022 were randomly assigned to receive one of four preventive methods: oxytocin, misoprostol, tranexamic acid, or prophylactic balloon catheterization. Data on the incidence of PPH, mean blood loss, need for additional interventions, and adverse events were collected and analyzed using logistic regression and ANOVA. The incidence of PPH was significantly lower in the tranexamic acid group (4%) and the prophylactic balloon catheterization group (6%) compared to the oxytocin group (16%) and the misoprostol group (14%). The mean blood loss was also significantly lower in the tranexamic acid and the prophylactic balloon catheterization groups than in the oxytocin and misoprostol groups. The need for additional interventions and adverse events were also significantly lower in the tranexamic acid and prophylactic balloon catheterization groups. Our study provides evidence to support tranexamic acid and prophylactic balloon catheterization as effective and safe preventive methods for PPH, with minimal side effects and low cost. Oxytocin remains a viable option for preventing PPH, but misoprostol should be used cautiously due to its higher incidence of adverse events.
... Comentario: la hemorragia posparto es una de las principales causas de muerte materna y morbilidad grave, particularmente en países con bajos recursos (9), lo que resalta la importancia de establecer medidas profilácticas adecuadas y eficaces. En la última década se han publicado investigaciones que sugieren la poca utilidad del masaje uterino después de la administración de oxitocina (10,11), y las recomendaciones de la OMS en hemorragia posparto lo señalan como una intervención con bajo nivel de evidencia y aparentemente no recomendable como medida adjunta a la oxitocina en la hemorragia posparto (12). No obstante, dichas investigaciones tienen limitaciones importantes en cuanto al tamaño de la muestra y la realización no estandarizada del procedimiento. ...
... Uterine atony is the first cause of hemorrhage at time of delivery; therefore, active management is better than expectant management of the third stage of labor. Third stage of labor is the period that following the delivery of a baby till placental delivery (6) . ...
... However, there has been very little experimental research to assess the effectiveness of this method. Results obtained in RCTs [19] [20], shows that uterine massage is less effective than oxytocin in reducing blood loss after delivery and there was no additional benefit when compared with of oxytocin alone. ...
Aim: To analyze the role of available health technologies and techniques in reducing the number of women dying during pregnancy and childbirth. Background: Health condition of women during pregnancy and childbirth is very sensitive. During this period, proper and timely care plays an important role in reducing maternal mortality. Design: Whitte more and Knafl's framework for integrative reviews was followed in the review. PUBMED/MEDLINE, CINHAL and COCHRANE were searched for published studies between 2008 and 2015. Studies included were systematic reviews, randomized control trials, prospective cohort study, literature review and descriptive studies. Methods: 28 articles were selected to be included in the review. An integrative review approach was followed to analyze data and draw conclusions. Screening of titles and abstracts along with data extraction was completed by two authors independently. Study quality is not reported because of the methodological difficulties. Data synthesis consists of writing descriptive summaries and thematic analysis of the key findings in the included articles. Results: The included studies were based on health technologies and techniques including different devices and tools, medication and drugs, massage techniques, immersion in water, intervention radiology, simulations and training for the health professional. Conclusion: There are numerous health technologies and techniques which are relatively simple to develop, effective to use and safe to apply with no adverse effects. These include simulations and training programs, educational and awareness programs , decision support tools and information systems. Besides these, there are technologies and techniques which show promising results with no or very little adverse effects. These include Ac-* Corresponding author. N. Naz et al. 134 tive management of the third stage of labour, use of magnesium sulphate, uterine balloon tampo-nade, wearable cardiac defibrillator and non-pneumatic anti-shock garment. The government, hospitals and care providers should make policies to develop and implement such type of technologies and techniques.
... La pérdida de sangre fue menor en el grupo del ácido tranexámico (173 mL frente a 221 mL; p = 0,041). Un ensayo clínico en el que participaron 1.964 mujeres con parto por vía vaginal evaluó el masaje uterino solo frente a la administración de 10 UI de oxitocina por vía IM frente a la combinación de ambas intervenciones (71). La frecuencia de pérdida igual o superior a 300 mL de sangre fue mayor en el grupo de masaje solo frente a la combinación de masaje y oxitocina (RR = 1,88; IC 95%: 1,29-2,74) o con la oxitocina sola (RR = 1,71; IC 95%: 1,11-2,61). ...
Objetivo: formular recomendaciones basadas en la mejor evidencia disponible que sirvan como guía para los profesionales de salud en la prevención, detección y el manejo de la hemorragia posparto y de las complicaciones asociadas a la misma con el fin de homogeneizar las conductas clínicas y contribuir a la reducción de la morbi-mortalidad materna.
Materiales y métodos: el grupo desarrollador de la Guía (GDG) elaboró esta GPC durante 2011-2012 acorde con la Guía Metodológica para la elaboración de Guías de Atención Integral en el Sistema Generalde Seguridad Social en Salud colombiano, basándose en la evidencia científica disponible y sumando la participación activa de grupos de pacientes, sociedades científicas y grupos de interés. En particular, la evidencia de esta Guía fue adaptada de las GPC del Royal College of Obstetricians and Gynaecologists (RCOG) “Prevention and management of postpartum haemorrhage” (2009) y de la Organización Mundial de la Salud (OMS), “WHO guidelines for the management of postpartum haemorrhage and retained placenta” (2009), y actualizada por medio de procedimientos sistemáticos, tanto para la búsqueda y la valoración de la evidencia, como para la generación de recomendaciones. El nivel de evidencia y la fuerza de las recomendaciones fueron expresadas por medio del sistema del Scottish Intercollegiate Guidelines Network (SIGN).
Resultados: se presentan recomendaciones para la prevención, detección y el tratamiento de la hemorragia posparto a partir de 17 preguntas clínicas.
Conclusión: se presenta una versión resumida de las recomendaciones y evidencia de esta Guía, que se espera sea adoptada por los profesionales de la salud encargados de la atención del embarazo en el país para disminuir la morbilidad y mortalidad asociada a la gestación.
... The flow of study identification is shown in Fig. 1. Only 3 RCTs comparing uterine massage vs no uterine massage were found [9][10][11]. The quality of these 3 trials in general was very low and both of them had high or unclear risk of bias in most of the seven Cochrane domains related to the risk of bias ( Fig. 2A and B). ...
... However, there has been very little experimental research to assess the effectiveness of this method. Results obtained in RCTs [19] [20], shows that uterine massage is less effective than oxytocin in reducing blood loss after delivery and there was no additional benefit when compared with of oxytocin alone. ...
Aim: To analyze the role of available health technologies and techniques in reducing the number of women dying during pregnancy and childbirth. Background: Health condition of women during pregnancy and childbirth is very sensitive. During this period, proper and timely care plays an important role in reducing maternal mortality. Design: Whitte more and Knal’s framework for integrative reviews was followed in the review. PUBMED/MEDLINE, CINHAL and COCHRANE were searched for published studies between 2008 and 2015. Studies included were systematic reviews, randomized control trials, prospective cohort study, literature review and descriptive studies. Methods: 28 articles were selected to be included in the review. An integrative review approach was followed to analyze data and draw conclusions. Screening of titles and abstracts along with data extraction was completed by two authors independently. Study quality is not reported because of the methodological difficulties. Data synthesis consists of writing descriptive summaries and thematic analysis of the key findings in the included articles. Results: The included studies were based on health technologies and techniques including different devices and tools, medication and drugs, massage techniques, immersion in water, intervention radiology, simulations and training for the health professional. Conclusion: There are numerous health technologies and techniques which are relatively simple to develop, effective to use and safe to apply with no adverse effects. These include simulations and training programs, educational and awareness programs, decision support tools and information systems. Besides these, there are technologies and techniques which show promising results with no or very little adverse effects. These include Active management of the third stage of labour, use of magnesium sulphate, uterine balloon tamponade, wearable cardiac defibrillator and non-pneumatic anti-shock garment. The government, hospitals and care providers should make policies to develop and implement such type of technologies and techniques.
... La pérdida de sangre fue menor en el grupo del ácido tranexámico (173 mL frente a 221 mL; p = 0,041). Un ensayo clínico en el que participaron 1.964 mujeres con parto por vía vaginal evaluó el masaje uterino solo frente a la administración de 10 UI de oxitocina por vía IM frente a la combinación de ambas intervenciones (71). La frecuencia de pérdida igual o superior a 300 mL de sangre fue mayor en el grupo de masaje solo frente a la combinación de masaje y oxitocina (RR = 1,88; IC 95%: 1,29-2,74) o con la oxitocina sola (RR = 1,71; IC 95%: 1,11-2,61). ...
Objective: To make recommendations based on the best available evidence designed to guide healthcare professionals in the prevention, detection and management of post-partum bleeding and complications associated with it, in order to arrive at uniform clinical practices and contribute to the reduction of maternal morbidity and mortality. Materials and methods: The Guideline Developer Group (GDG) prepared this CPG during 2011-2012, in accordance with the Methodology Guideline for the development of Comprehensive Care Guidelines of the Colombian General System of Social Security, based on the available scientific evidence, and with the active participation of patient groups, scientific societies and stakeholders. In particular, the evidence for these Guidelines was adapted from the CPG of the Royal College of Obstetricians and Gynaecologists (RCOG) "Prevention and management of postpartum haemorrhage" (2009) and of the World Health Organization (WHO), "WHO guidelines for the management of postpartum haemorrhage and retained placenta" (2009) and updated through systematic procedures for the search and assessment of the evidence as well as for the generation of recommendations. The level of evidence and the power of the recommendations were expressed using the Scottish Intercollegiate Guidelines Network (SIGN) system. Results: Recommendations are presented for the prevention, detection and treatment of postpartum haemorrhage based on 17 clinical questions. Conclusion: We present a summarized version of the recommendations and the evidence for these guidelines, which are expected to be adopted by healthcare practitioners in charge of pregnancy care in Colombia, in order to reduce pregnancyassociated morbidity and mortality.
... Oxytocin and misoprostol lower the risk of PPH; however misoprostol appears to have heterogeneous effects depending on whether it is used with or without skilled attendance at (Table 3). Based on a Cochrane meta-analysis, we estimated the RR of PPH with oxytocin (versus placebo) in the setting of skilled attendance at delivery as 0.53 (95% CI: 0.38, 0.74) [38,39]. We pooled estimates from two trials (S2 Fig) [11,40], that compared the risk of PPH with misoprostol versus placebo in a setting of skilled assistance at delivery (RR 0.84; 95% CI: 0.73, 0.97); and the RR of PPH with misoprostol (versus placebo) in unskilled births was estimated from the trial of Derman et al. [10] as 0.53 (95% CI: 0.39, 0.74). ...
In settings where home birth rates are high, prenatal distribution of misoprostol has been advocated as a strategy to increase access to uterotonics during the third stage of labor to prevent postpartum hemorrhage (PPH). Our objective was to project the potential cost-effectiveness of this strategy in Uganda from both governmental (the relevant payer) and modified societal perspectives.To compare prenatal misoprostol distribution to status quo (no misoprostol distribution), we developed a decision analytic model that tracked the delivery pathways of a cohort of pregnant women from the prenatal period, labor to delivery without complications or delivery with PPH, and successful treatment or death. Delivery pathway parameters were derived from the Uganda Demographic and Health Survey. Incidence of PPH, treatment efficacy, adverse event and case fatality rates, access to misoprostol, and health resource use and cost data were obtained from published literature and supplemented with expert opinion where necessary. We computed the expected incidence of PPH, mortality, disability adjusted life years (DALYs), costs and incremental cost effectiveness ratios (ICERs). We conducted univariate and probabilistic sensitivity analyses to examine robustness of our results. In the base-case analysis, misoprostol distribution lowered the expected incidence of PPH by 1.2% (95% credibility interval (CrI): 0.55%, 1.95%), mortality by 0.08% (95% CrI: 0.04%, 0.13%) and DALYs by 0.02 (95% CrI: 0.01, 0.03).” and “ICERs were US$181 (95% CrI: 81, 443) per DALY averted from a governmental perspective, and US$64 (95% CrI: -84, 260) per DALY averted from a modified societal perspective [corrected].Prenatal distribution of misoprostol is potentially cost-effective in Uganda and should be considered for national-level scale up for prevention of PPH.
... Of these, 321 were randomly assigned to the misoprostol group and 331 were randomly assigned to the oxytocin group ( Figure 1). As observed in various hospital-based trials with follow-up through hospital discharge only, 27,[31][32][33] there was no loss to follow-up. The reproductive health characteristics of the subjects and the birthweights of the newborns were comparable (Table 1). ...
Objective Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 lg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. Design Double-blind randomised controlled trial. Setting A teaching hospital: J N Medical College, Belgaum, India. Sample A cohort of 652 consenting eligible pregnant women admitted to the labour room. Methods Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively. Main outcome measures Measured mean postpartum blood loss and haemorrhage (PPH, loss ‡500 ml), >10% pre-to post-partum decline in haemoglobin, and reported side effects. Results The mean blood loss with sublingual misoprostol was 192 ± 124 ml (n = 321) and 366 ± 136 ml with oxytocin IM (n = 331, P £ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P = 0.002). No woman lost ‡1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P £ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. Conclusion Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results.
... Le massage utérin semble augmenter les risques d'HPP ou bien n'offrir aucun bénéfice 51 ce qui est cohérent avec la recherche antérieure. 52 De plus, il ne fait pas partie de la gestion active du 3e stade tel que recommandé par l'OMS en 2007. 53 ...
... Le massage utérin semble augmenter les risques d'HPP ou bien n'offrir aucun bénéfice 51 ce qui est cohérent avec la recherche antérieure. 52 De plus, il ne fait pas partie de la gestion active du 3e stade tel que recommandé par l'OMS en 2007. 53 ...
... Le massage utérin semble augmenter les risques d'HPP ou bien n'offrir aucun bénéfice 51 ce qui est cohérent avec la recherche antérieure. 52 De plus, il ne fait pas partie de la gestion active du 3e stade tel que recommandé par l'OMS en 2007. 53 ...
... [10][11][12][13] These components aside, what is clear in the literature is that uterotonic drugs can safely and effectively prevent PPH. [14][15][16] The relative safety, efficacy, and effectiveness of misoprostol to reduce the incidence of PPH as compared to oxytocin, ergometrine, and placebo have been demonstrated in both health facilities and community contexts. [16][17][18][19][20][21] In settings where active management of the third stage cannot be provided by a skilled attendant, the World Health Organization (WHO) and other global health organizations recommend that oral administration of misoprostol be offered to women by a trained community health worker for PPH prevention. ...
Introduction:
Postpartum hemorrhage (PPH) is responsible for a significant proportion of maternal mortality in developing countries. The uterotonic drug misoprostol (Cytotec) is a safe and effective means of preventing PPH. However, ministries of health in some countries are still grappling with policy that addresses the implementation of this targeted intervention in community settings and with communicating this policy throughout the health care system. The purpose of this study was to examine understandings of national policy for community-based use of misoprostol to prevent PPH in 2 regions of Ethiopia: Amhara and Oromiya.
Methods:
Qualitative in-depth interviews were conducted with a cohort of purposefully selected health officials (N = 51) representing various administrative levels of the Ministry of Health and influential nongovernmental organizations. Broad topics included national policy for PPH prevention, safety and effectiveness of community-based use of misoprostol, and preferences for misoprostol administration. Interview transcripts were analyzed for key concepts both across and within administrative levels.
Results:
Among all officials, understandings of national policy for community-based PPH prevention using misoprostol were unclear. Officials in Amhara tended to adopt a strict interpretation that reflected fear of misuse and a deep concern for encouraging home birth (thus deviating from the clear national goal to increase facility-based birth). Conversely, Oromiya officials framed policy in terms of the broader national goal to reduce maternal mortality, which allowed them to adopt multiple means of misoprostol distribution.
Discussion:
The differences observed in regional practice likely stem from an ambiguously perceived national policy within a climate of decentralization that allowed for flexibility in local implementation. A policy that is clear, specific, evidence-based, and systematically communicated may facilitate common understanding of community-based misoprostol for PPH prevention and, thus, increase women's access to this lifesaving intervention.
... [10][11][12][13] These components aside, what is clear in the literature is that uterotonic drugs can safely and effectively prevent PPH. [14][15][16] The relative safety, efficacy, and effectiveness of misoprostol to reduce the incidence of PPH as compared to oxytocin, ergometrine, and placebo have been demonstrated in both health facilities and community contexts. [16][17][18][19][20][21] In settings where active management of the third stage cannot be provided by a skilled attendant, the World Health Organization (WHO) and other global health organizations recommend that oral administration of misoprostol be offered to women by a trained community health worker for PPH prevention. ...
Introduction:
In Ethiopia, postpartum hemorrhage is a leading cause of maternal death. The Maternal Health in Ethiopia Partnership (MaNHEP) project developed a community-based model of maternal and newborn health focusing on birth and early postpartum care. Implemented in the Amhara and Oromiya regions, the model included misoprostol to prevent postpartum hemorrhage. This article describes regional trends in women's use of misoprostol; their awareness, receipt, and use of misoprostol at project's endline; and factors associated with its use.
Methods:
The authors assessed trends in use of misoprostol using monthly data from MaNHEP's quality improvement database; and awareness, receipt, use, and correct use of misoprostol using data from MaNHEP's endline survey of 1019 randomly sampled women who gave birth during the year prior to the survey.
Results:
Misoprostol use increased rapidly and was relatively stable over 20 months, but regional differences were stark. At endline, significantly more women in Oromiya were aware of misoprostol compared with women who resided in Amhara (94% vs 59%); significantly more had received misoprostol (80% vs 35%); significantly more had received it during pregnancy (93% vs 48%); and significantly more had received it through varied sources. Most women who received misoprostol used it (> 95%) irrespective of age, parity, or education. Factors associated with use were Oromiya residence (odds ratio [OR] 9.48; 95% confidence interval [CI], 6.78-13.24), attending 2 or more Community Maternal and Newborn Health (CMNH) family meetings (OR 2.62; 95% CI, 1.89-3.63), receiving antenatal care (OR 1.67; 95% CI, 1.08-2.58) and being attended at birth by a skilled provider or trained health extension worker, community health development agent, or traditional birth attendant versus an untrained caregiver or no one. Correct use was associated with having attended 2 or more CMNH family meetings (OR 2.02; 95% CI, 1.35-3.03).
Discussion:
Multiple distribution channels increase women's access to misoprostol. Most women who have access to misoprostol use it. Early distribution to pregnant women who are educated to use misoprostol appears to be safe and unrelated to choice of birthplace.
... We propose that a single, simple definition be developed based on current evidence. This definition of AMTSL should include the use of an oxytocic agent, preferably 10 IU of intramuscular oxytocin [17], and exclude CCT and uterine massage because of evidence that they are not effective strategies for preventing PPH [20,24]. There is no conclusive evidence that delayed cord clamping is effective if used in all deliveries and there is a lack of agreement on the definition of delayed cord clamping, as exemplified in the most recent guidelines from WHO and FIGO [22,23]. ...
Objective:
To determine whether healthcare providers performed active management of the third stage of labor (AMTSL) as defined by FIGO/ICM and WHO, and as described by the Cochrane Collaboration.
Methods:
In a prospective observational study, a questionnaire regarding knowledge of AMTSL was administered to healthcare providers in the largest maternity teaching center in Colombia. It was subsequently observed whether and how the healthcare providers performed AMTSL in practice. The percentage of correct use of AMTSL was calculated.
Results:
Healthcare providers indicated they knew what AMTSL was but disagreed on the timing of prophylactic oxytocin use. In total, 241 deliveries were observed. Oxytocin at varying doses and routes was used in 239 (99.2%) deliveries. In all deliveries, the umbilical cord was clamped early. In 49 (20.3%) deliveries, controlled cord traction was performed. Uterine massage was carried out in 213 (88.4%) deliveries. According to the FIGO/ICM and WHO definitions, and the Cochrane Collaboration description, correct use of AMTSL occurred in 0.8%, 0.0%, and 8.3%, of cases, respectively.
Conclusion:
Correct use of AMTSL is low at the largest maternity teaching center in Colombia. There is an urgent need for a single definition of AMTSL, which could be used globally for research, training, and scaling-up the performance of AMTSL.
Background: Post-partum haemorrhage condition is a serious condition after delivery. Objective: The purpose of the present study was to see the efficacy and safety of misoprostol for the prevention of post-partum haemorrhage. Methodology: This analytic cross-sectional study was carried out in the Department of Gynaecology and Obstetrics at Mymensingh Medical College Hospital (MMCH), Mymensingh, Bangladesh from January 2006 to June 2006 for a period of six months. Pregnant women who were admitted in MMCH during the above period and were expected to have vaginal delivery and women at term with singleton pregnancy were included as study population. Women were divided into 2 groups. Women were in the group A who were treated with misoprostol and women who were treated with oxytocin were in group B. Blood loss during delivery was estimated subjectively by the attending obstetrician. Results: A total number of 100 women were recruited for this study of which 50 women were in the group A and the rest of 50 women were in group B. In this study majority of the patients were belonged to age group 20 to 25 years in both the groups. In oxytocin group 2.0% have developed nausea, 4.0% patients have developed shivering. None have developed vomiting, diarrhoea, temperature. In misoprostol group 10.0% patients have developed nausea, 18.0% patients have developed shivering, 4.0% patients have developed rise of temperature, none have developed diarrhoea, vomiting. The differences were statistically significant. In this study 4.0% patients from oxytocin group and 2.0% patient from misoprostol group required blood transfusion. Conclusion: In conclusion less amount of blood loss is found in misoprostol group than oxytocin group. Journal of National Institute of Neurosciences Bangladesh, July 2021, Vol. 7, No. 2, pp. 152-155
Objective This study aimed to compare the effectiveness of sustained uterine compression versus uterine massage in reducing blood loos after a vaginal delivery.
Study Design This was a prospective randomized trial conducted at the American University of Beirut Medical Center (AUBMC) between October 2015 and October 2017. Inclusion criteria were women with a singleton pregnancy at ≥36 weeks of gestation, with less than three previous deliveries, who were candidates for vaginal delivery. Participants were randomized into two groups, a sustained uterine compression group (group 1) and a uterine massage group (group 2). Incidence of postpartum hemorrhage (blood loss of ≥500 mL) was the primary outcome. We assumed that the incidence of postpartum hemorrhage at our institution is similar to previously published studies. A total of 545 women were required in each arm to detect a reduction from 9.6 to 4.8% in the primary outcome (50% reduction) with a one-sided α of 0.05 and a power of 80%. Factoring in a 10% dropout rate. Secondary outcomes were admission to intensive care unit (ICU), postpartum complications, drop in hemoglobin, duration of hospital stay, maternal pain, use of uterotonics, or of surgical procedure for postpartum hemorrhage.
Results A total of 550 pregnant women were recruited, 273 in group 1 and 277 in group 2. There was no statistically significant difference in baseline characteristics between the two groups. Type of anesthesia, rate of episiotomy, lacerations, and mean birth weight were also equal between the groups. Incidence of the primary outcome was not different between the two groups (group 1: 15.5%, group 2: 15.4%; p = 0.98). There was no statistically significant difference in any of the secondary outcomes between the two groups, including drop in hemoglobin (p = 0.79).
Conclusion There was no difference in blood loss between sustained uterine compression and uterine massage after vaginal delivery.
Key Points
Background/Objective To estimate the effectiveness of uterine massage UM in reducing blood loss before delivery of placenta in CS.
Methods This was a retrospective cohort study of 1393 women who delivered with CS. Patients who underwent UM (671women) were compared with those who underwent controlled cord traction (722 women). According to risk assessment of PPH, 2 groups were both divided to low risk group and high risk group. Outcomes included blood loss amount within 2 h after delivery, incidence of PPH and intractable PPH.
Results Blood loss amount within 2 h was lower in UM group than CCT group(516.6±196.5 ml compared with 674.1±272.2 ml, P<0.01). The incidence of PPH and intractable PPH didn’t differ significantly between the 2 groups (6.7% compared with 9.1%, P=0.09 and 3.9% compared with 5.3%, P=0.22,respectively).In high risk group, the amount of blood loss within 2 h and the incidence of PPH were both lower in UM group (n=382) than CCT group (n=407) (576.8±228.1 ml compared with 854.9±346.1 ml, P<0.01 and 7.1% compared with 11.3%,P=0.04 ,respectively). The incidence of intractable PPH didn’t differ significantly between the 2 groups (4.7% compared with 6.9%,P=0.19). In low risk group, the 3 outcomes didn’t differ significantly between the 2 groups(n=289 vs. 315) (428.5±172.6 ml compared with 447.9±180.5 ml; 6.2% compared with 6.3%; 2.8% compared with 3.2%; P=0.56, 0.95 and 0.77,respectively).
Conclusion In high risk patients of PPH, UM before delivery of placenta contributed to reduce blood loss in CS.
Background:
Active management of the third stage of labour reduces the risk of postpartum blood loss (postpartum haemorrhage (PPH)), and is defined as administration of a prophylactic uterotonic, early umbilical cord clamping and controlled cord traction to facilitate placental delivery. The choice of uterotonic varies across the globe and may have an impact on maternal outcomes. This is an update of a review first published in 2001 and last updated in 2013.
Objectives:
To determine the effectiveness of prophylactic oxytocin to prevent PPH and other adverse maternal outcomes in the third stage of labour.
Search methods:
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) (6 March 2019) and reference lists of retrieved studies.
Selection criteria:
Randomised, quasi- or cluster-randomised trials including women undergoing vaginal delivery who received prophylactic oxytocin during management of the third stage of labour. Primary outcomes were blood loss 500 mL or more after delivery, need for additional uterotonics, and maternal all-cause mortality.
Data collection and analysis:
Two review authors independently assessed trials for inclusion, extracted data, and assessed trial quality. Data were checked for accuracy. We assessed the quality of the evidence using the GRADE approach.
Main results:
This review includes 24 trials, with 23 trials involving 10,018 women contributing data. Due to many trials assessed at high risk of bias, evidence grade ranged from very low to moderate quality.Prophylactic oxytocin versus no uterotonics or placebo (nine trials)Prophylactic oxytocin compared with no uterotonics or placebo may reduce the risk of blood loss of 500 mL after delivery (average risk ratio (RR) 0.51, 95% confidence interval (C) 0.37 to 0.72; 4162 women; 6 studies; Tau² = 0.10, I² = 75%; low-quality evidence), and blood loss 1000 mL after delivery (RR 0.59, 95% CI 0.42 to 0.83; 4123 women; 5 studies; low-quality evidence). Prophylactic oxytocin probably reduces the need for additional uterotonics (average RR 0.54, 95% CI 0.36 to 0.80; 3135 women; 4 studies; Tau² = 0.07, I² = 44%; moderate-quality evidence). There may be no difference in the risk of needing a blood transfusion in women receiving oxytocin compared to no uterotonics or placebo (RR 0.88, 95% CI 0.44 to 1.78; 3081 women; 3 studies; low-quality evidence). Oxytocin may be associated with an increased risk of a third stage greater than 30 minutes (RR 2.55, 95% CI 0.88 to 7.44; 1947 women; 1 study; moderate-quality evidence), however the confidence interval is wide and includes 1.0, indicating that there may be little or no difference.Prophylactic oxytocin versus ergot alkaloids (15 trials)It is uncertain whether oxytocin reduces the likelihood of blood loss 500 mL (average RR 0.84, 95% CI 0.56 to 1.25; 3082 women; 10 studies; Tau² = 0.14, I² = 49%; very low-quality evidence) or the need for additional uterotonics compared to ergot alkaloids (average RR 0.89, 95% CI 0.43 to 1.81; 2178 women; 8 studies; Tau² = 0.76, I² = 79%; very low-quality evidence), because the quality of this evidence is very low. The quality of evidence was very low for blood loss of 1000 mL (RR 1.13, 95% CI 0.63 to 2.01; 1577 women; 3 studies; very low-quality evidence), and need for blood transfusion (average RR 1.37, 95% CI 0.34 to 5.51; 1578 women; 7 studies; Tau² = 1.34, I² = 45%; very low-quality evidence), making benefit of oxytocin over ergot alkaloids uncertain. Oxytocin probably increases the risk of a prolonged third stage greater than 30 minutes (RR 4.69, 95% CI 1.63 to 13.45; 450 women; 2 studies; moderate-quality evidence), although it is uncertain if this translates into increased risk of manual placental removal (average RR 1.10, 95% CI 0.39 to 3.10; 3127 women; 8 studies; Tau² = 1.07, I² = 76%; very low-quality evidence). Oxytocin may make little or no difference to risk of diastolic blood pressure > 100 mm Hg (average RR 0.28, 95% CI 0.04 to 2.05; 960 women; 3 studies; Tau² = 1.23, I² = 50%; low-quality evidence), and is probably associated with a lower risk of vomiting (RR 0.09, 95% CI 0.05 to 0.14; 1991 women; 7 studies; moderate-quality evidence), although the impact of oxytocin on headaches is uncertain (average RR 0.19, 95% CI 0.03 to 1.02; 1543 women; 5 studies; Tau² = 2.54, I² = 72%; very low-quality evidence).Prophylactic oxytocin-ergometrine versus ergot alkaloids (four trials)Oxytocin-ergometrine may slightly reduce the risk of blood loss greater than 500 mL after delivery compared to ergot alkaloids (RR 0.44, 95% CI 0.20 to 0.94; 1168 women; 3 studies; low-quality evidence), based on outcomes from quasi-randomised trials with a high risk of bias. There were no maternal deaths reported in either treatment group in the one trial that reported this outcome (RR not estimable; 1 trial, 807 women; moderate-quality evidence). Need for additional uterotonics was not reported.No subgroup differences were observed between active or expectant management, or different routes or doses of oxytocin for any of our comparisons.
Authors' conclusions:
Prophylactic oxytocin compared with no uterotonics may reduce blood loss and the need for additional uterotonics. The effect of oxytocin compared to ergot alkaloids is uncertain with regards to blood loss, need for additional uterotonics, and blood transfusion. Oxytocin may increase the risk of a prolonged third stage compared to ergot alkaloids, although whether this translates into increased risk of manual placental removal is uncertain. This potential risk must be weighed against the possible increased risk of side effects associated with ergot alkaloids. Oxytocin-ergometrine may reduce blood loss compared to ergot alkaloids, however the certainty of this conclusion is low. More high-quality trials are needed to assess optimal dosing and route of oxytocin administration, with inclusion of important outcomes such as maternal mortality, shock, and transfer to a higher level of care. A network meta-analysis of uterotonics for PPH prevention plans to address issues around optimal dosing and routes of oxytocin and other uterotonics.
( Br J Anaesth . 2015;114:576–587)
Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one-quarter of all maternal deaths worldwide. Uterotonics after birth are the only intervention that has been shown to be effective for PPH prevention. Tranexamic acid (TXA), an antifibrinolytic agent, has therefore been investigated as a potentially useful complement to this for both prevention and treatment because its hypothesized mechanism of action in PPH supplements that of uterotonics and because it has been proven to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. This review covers evidence from randomized controlled trials (RCTs) for PPH prevention after cesarean (n1/410) and vaginal (n1/42) deliveries and for PPH treatment after vaginal delivery (n1/41). It discusses TXA efficacy and side effects overall and in relation to the various doses studied for both indications.
Background
Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic drugs can reduce blood loss and are routinely recommended. There are several uterotonic drugs for preventing PPH, but it is still debatable which drug or combination of drugs is the most effective.
Objectives
To identify the most effective and cost-effective uterotonic drug(s) to prevent PPH, and generate a ranking according to their effectiveness and side-effect profile.
Methods
The Cochrane Pregnancy and Childbirth’s Trials Register (1 June 2015), ClinicalTrials.gov and the World Health Organization (WHO)’s International Clinical Trials Registry Platform (ICTRP) were searched for unpublished trial reports (30 June 2015). In addition, reference lists of retrieved studies (updated October 2017) were searched for randomised trials evaluating uterotonic drugs for preventing PPH. The study estimated relative effects and rankings for preventing PPH, defined as blood loss of ≥ 500 ml and ≥ 1000 ml. Pairwise meta-analyses and network meta-analysis were performed to determine the relative effects and rankings of all available drugs and combinations thereof [ergometrine, misoprostol (Cytotec ® ; Pfizer Inc., New York, NY, USA), misoprostol plus oxytocin (Syntocinon ® ; Novartis International AG, Basel, Switzerland), carbetocin (Pabal ® ; Ferring Pharmaceuticals, Saint-Prex, Switzerland), ergometrine plus oxytocin (Syntometrine ® ; Alliance Pharma plc, Chippenham, UK), oxytocin, and a placebo or no treatment]. Primary outcomes were stratified according to the mode of birth, prior risk of PPH, health-care setting, drug dosage, regimen and route of drug administration. Sensitivity analyses were performed according to study quality and funding source, among others. A model-based economic evaluation compared the relative cost-effectiveness separately for vaginal births and caesareans with or without including side effects.
Results
From 137 randomised trials and 87,466 women, ergometrine plus oxytocin, carbetocin and misoprostol plus oxytocin were found to reduce the risk of PPH blood loss of ≥ 500 ml compared with the standard drug, oxytocin [ergometrine plus oxytocin: risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.83; carbetocin: RR 0.72, 95% CI 0.52 to 1.00; misoprostol plus oxytocin: RR 0.73, 95% CI 0.6 to 0.9]. Each of these three strategies had 100% cumulative probability of being ranked first, second or third most effective. Oxytocin was ranked fourth, with an almost 0% cumulative probability of being ranked in the top three. Similar rankings were noted for the reduction of PPH blood loss of ≥ 1000 ml (ergometrine plus oxytocin: RR 0.77, 95% CI 0.61 to 0.95; carbetocin: RR 0.70, 95% CI 0.38 to 1.28; misoprostol plus oxytocin: RR 0.90, 95% CI 0.72 to 1.14), and most secondary outcomes. Ergometrine plus oxytocin and misoprostol plus oxytocin had the poorest ranking for side effects. Carbetocin had a favourable side-effect profile, which was similar to oxytocin. However, the analysis was restricted to high-quality studies, carbetocin lost its ranking and was comparable to oxytocin. The relative cost-effectiveness of the alternative strategies is inconclusive, and the results are affected by both the uncertainty and inconsistency in the data reported on adverse events. For vaginal delivery, when assuming no adverse events, ergometrine plus oxytocin is less costly and more effective than all strategies except carbetocin. The strategy of carbetocin is both more effective and more costly than all other strategies. When taking adverse events into consideration, all prevention strategies, except oxytocin, are more costly and less effective than carbetocin. For delivery by caesarean section, with and without adverse events, the relative cost-effectiveness is different, again because of the uncertainty in the available data.
Limitations
There was considerable uncertainty in findings within the planned subgroup analyses, and subgroup effects cannot be ruled out.
Conclusions
Ergometrine plus oxytocin, carbetocin and misoprostol plus oxytocin are more effective uterotonic drug strategies for preventing PPH than the current standard, oxytocin. Ergometrine plus oxytocin and misoprostol plus oxytocin cause significant side effects. Carbetocin has a favourable side-effect profile, which was similar to oxytocin. However, most carbetocin trials are small and of poor quality. There is a need for a large high-quality trial comparing carbetocin with oxytocin; such a trial is currently being conducted by the WHO. The relative cost-effectiveness is inconclusive, and results are affected by uncertainty and inconsistency in adverse events data.
Study registration
This study is registered as PROSPERO CRD42015020005; Cochrane Pregnancy and Childbirth Group (substudy) reference number 0871; PROSPERO–Cochrane (substudy) reference number CRD42015026568; and sponsor reference number ERN_13–1414 (University of Birmingham, Birmingham, UK).
Funding
Funding for this study was provided by the National Institute for Health Research Health Technology Assessment programme in a research award to the University of Birmingham and supported by the UK charity Ammalife (UK-registered charity 1120236). The funders of the study had no role in study design, data collection, data synthesis, interpretation or writing of the report.
Background:
Active management of the third stage of labour involves giving a prophylactic uterotonic, early cord clamping and controlled cord traction to deliver the placenta. With expectant management, signs of placental separation are awaited and the placenta is delivered spontaneously. Active management was introduced to try to reduce haemorrhage, a major contributor to maternal mortality in low-income countries. This is an update of a review last published in 2015.
Objectives:
To compare the effects of active versus expectant management of the third stage of labour on severe primary postpartum haemorrhage (PPH) and other maternal and infant outcomes.To compare the effects of variations in the packages of active and expectant management of the third stage of labour on severe primary PPH and other maternal and infant outcomes.
Search methods:
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the World health Organization International Clinical Trials Registry Platform (ICTRP), on 22 January 2018, and reference lists of retrieved studies.
Selection criteria:
Randomised and quasi-randomised controlled trials comparing active versus expectant management of the third stage of labour. Cluster-randomised trials were eligible for inclusion, but none were identified.
Data collection and analysis:
Two review authors independently assessed the studies for inclusion, assessed risk of bias, carried out data extraction and assessed the quality of the evidence using the GRADE approach.
Main results:
We included eight studies, involving analysis of data from 8892 women. The studies were all undertaken in hospitals, seven in higher-income countries and one in a lower-income country. Four studies compared active versus expectant management, and four compared active versus a mixture of managements. We used a random-effects model in the analyses because of clinical heterogeneity. Of the eight studies included, we considered three studies as having low risk of bias in the main aspects of sequence generation, allocation concealment and completeness of data collection. There was an absence of high-quality evidence according to GRADE assessments for our primary outcomes, which is reflected in the cautious language below.The evidence suggested that, for women at mixed levels of risk of bleeding, it is uncertain whether active management reduces the average risk of maternal severe primary PPH (more than 1000 mL) at time of birth (average risk ratio (RR) 0.34, 95% confidence interval (CI) 0.14 to 0.87, 3 studies, 4636 women, I2 = 60%; GRADE: very low quality). For incidence of maternal haemoglobin (Hb) less than 9 g/dL following birth, active management of the third stage may reduce the number of women with anaemia after birth (average RR 0.50, 95% CI 0.30 to 0.83, 2 studies, 1572 women; GRADE: low quality). We also found that active management of the third stage may make little or no difference to the number of babies admitted to neonatal units (average RR 0.81, 95% CI 0.60 to 1.11, 2 studies, 3207 infants; GRADE: low quality). It is uncertain whether active management of the third stage reduces the number of babies with jaundice requiring treatment (RR 0.96, 95% CI 0.55 to 1.68, 2 studies, 3142 infants, I2 = 66%; GRADE: very low quality). There were no data on our other primary outcomes of very severe PPH at the time of birth (more than 2500 mL), maternal mortality, or neonatal polycythaemia needing treatment.Active management reduces mean maternal blood loss at birth and probably reduces the rate of primary blood loss greater than 500 mL, and the use of therapeutic uterotonics. Active management also probably reduces the mean birthweight of the baby, reflecting the lower blood volume from interference with placental transfusion. In addition, it may reduce the need for maternal blood transfusion. However, active management may increase maternal diastolic blood pressure, vomiting after birth, afterpains, use of analgesia from birth up to discharge from the labour ward, and more women returning to hospital with bleeding (outcome not pre-specified).In the comparison of women at low risk of excessive bleeding, there were similar findings, except it was uncertain whether there was a difference identified between groups for severe primary PPH (average RR 0.31, 95% CI 0.05 to 2.17; 2 studies, 2941 women, I2 = 71%), maternal Hb less than 9 g/dL at 24 to 72 hours (average RR 0.17, 95% CI 0.02 to 1.47; 1 study, 193 women) or the need for neonatal admission (average RR 1.02, 95% CI 0.55 to 1.88; 1 study, 1512 women). In this group, active management may make little difference to the rate of neonatal jaundice requiring phototherapy (average RR 1.31, 95% CI 0.78 to 2.18; 1 study, 1447 women).Hypertension and interference with placental transfusion might be avoided by using modifications to the active management package, for example, omitting ergot and deferring cord clamping, but we have no direct evidence of this here.
Authors' conclusions:
Although the data appeared to show that active management reduced the risk of severe primary PPH greater than 1000 mL at the time of birth, we are uncertain of this finding because of the very low-quality evidence. Active management may reduce the incidence of maternal anaemia (Hb less than 9 g/dL) following birth, but harms such as postnatal hypertension, pain and return to hospital due to bleeding were identified.In women at low risk of excessive bleeding, it is uncertain whether there was a difference between active and expectant management for severe PPH or maternal Hb less than 9 g/dL (at 24 to 72 hours). Women could be given information on the benefits and harms of both methods to support informed choice. Given the concerns about early cord clamping and the potential adverse effects of some uterotonics, it is critical now to look at the individual components of third-stage management. Data are also required from low-income countries.It must be emphasised that this review includes only a small number of studies with relatively small numbers of participants, and the quality of evidence for primary outcomes is low or very low.
Background:
Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic agents can prevent PPH, and are routinely recommended. The current World Health Organization (WHO) recommendation for preventing PPH is 10 IU (international units) of intramuscular or intravenous oxytocin. There are several uterotonic agents for preventing PPH but there is still uncertainty about which agent is most effective with the least side effects. This is an update of a Cochrane Review which was first published in April 2018 and was updated to incorporate results from a recent large WHO trial.
Objectives:
To identify the most effective uterotonic agent(s) to prevent PPH with the least side effects, and generate a ranking according to their effectiveness and side-effect profile.
Search methods:
We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (24 May 2018), and reference lists of retrieved studies.
Selection criteria:
All randomised controlled trials or cluster-randomised trials comparing the effectiveness and side effects of uterotonic agents with other uterotonic agents, placebo or no treatment for preventing PPH were eligible for inclusion. Quasi-randomised trials were excluded. Randomised trials published only as abstracts were eligible if sufficient information could be retrieved.
Data collection and analysis:
At least three review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for preventing PPH ≥ 500 mL and PPH ≥ 1000 mL as primary outcomes. Secondary outcomes included blood loss and related outcomes, morbidity outcomes, maternal well-being and satisfaction and side effects. Primary outcomes were also reported for pre-specified subgroups, stratifying by mode of birth, prior risk of PPH, healthcare setting, dosage, regimen and route of administration. We performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available agents.
Main results:
The network meta-analysis included 196 trials (135,559 women) involving seven uterotonic agents and placebo or no treatment, conducted across 53 countries (including high-, middle- and low-income countries). Most trials were performed in a hospital setting (187/196, 95.4%) with women undergoing a vaginal birth (71.5%, 140/196).Relative effects from the network meta-analysis suggested that all agents were effective for preventing PPH ≥ 500 mL when compared with placebo or no treatment. The three highest ranked uterotonic agents for prevention of PPH ≥ 500 mL were ergometrine plus oxytocin combination, misoprostol plus oxytocin combination and carbetocin. There is evidence that ergometrine plus oxytocin (RR 0.70, 95% CI 0.59 to 0.84, moderate certainty), carbetocin (RR 0.72, 95% CI 0.56 to 0.93, moderate certainty) and misoprostol plus oxytocin (RR 0.70, 95% CI 0.58 to 0.86, low certainty) may reduce PPH ≥ 500 mL compared with oxytocin. Low-certainty evidence suggests that misoprostol, injectable prostaglandins, and ergometrine may make little or no difference to this outcome compared with oxytocin.All agents except ergometrine and injectable prostaglandins were effective for preventing PPH ≥ 1000 mL when compared with placebo or no treatment. High-certainty evidence suggests that ergometrine plus oxytocin (RR 0.83, 95% CI 0.66 to 1.03) and misoprostol plus oxytocin (RR 0.88, 95% CI 0.70 to 1.11) make little or no difference in the outcome of PPH ≥ 1000 mL compared with oxytocin. Low-certainty evidence suggests that ergometrine may make little or no difference to this outcome compared with oxytocin meanwhile the evidence on carbetocin was of very low certainty. High-certainty evidence suggests that misoprostol is less effective in preventing PPH ≥ 1000 mL when compared with oxytocin (RR 1.19, 95% CI 1.01 to 1.42). Despite the comparable relative treatment effects between all uterotonics (except misoprostol) and oxytocin, ergometrine plus oxytocin, misoprostol plus oxytocin combinations and carbetocin were the highest ranked agents for PPH ≥ 1000 mL.Misoprostol plus oxytocin reduces the use of additional uterotonics (RR 0.56, 95% CI 0.42 to 0.73, high certainty) and probably also reduces the risk of blood transfusion (RR 0.51, 95% CI 0.37 to 0.70, moderate certainty) when compared with oxytocin. Carbetocin, injectable prostaglandins and ergometrine plus oxytocin may also reduce the use of additional uterotonics but the certainty of the evidence is low. No meaningful differences could be detected between all agents for maternal deaths or severe morbidity as these outcomes were rare in the included randomised trials where they were reported.The two combination regimens were associated with important side effects. When compared with oxytocin, misoprostol plus oxytocin combination increases the likelihood of vomiting (RR 2.11, 95% CI 1.39 to 3.18, high certainty) and fever (RR 3.14, 95% CI 2.20 to 4.49, moderate certainty). Ergometrine plus oxytocin increases the likelihood of vomiting (RR 2.93, 95% CI 2.08 to 4.13, moderate certainty) and may make little or no difference to the risk of hypertension, however absolute effects varied considerably and the certainty of the evidence was low for this outcome.Subgroup analyses did not reveal important subgroup differences by mode of birth (caesarean versus vaginal birth), setting (hospital versus community), risk of PPH (high versus low risk for PPH), dose of misoprostol (≥ 600 mcg versus < 600 mcg) and regimen of oxytocin (bolus versus bolus plus infusion versus infusion only).
Authors' conclusions:
All agents were generally effective for preventing PPH when compared with placebo or no treatment. Ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination may have some additional desirable effects compared with the current standard oxytocin. The two combination regimens, however, are associated with significant side effects. Carbetocin may be more effective than oxytocin for some outcomes without an increase in side effects.
Carbetocin is more heat stable than oxytocin with at least equivalent efficacy for preventing postpartum hemorrhage. It will certainly be helpful if the supplier can make it available in low-income country settings at a price comparable to oxytocin. But even so, programs will still need oxytocin and other uterotonic medications.
Background
Postpartum hemorrhage (PPH) is a threat to maternal mortality worldwide. Evidence supports active management of third stage labor (AMTSL) for preventing PPH. However, trials of AMTSL include women at varying risk levels, such as women undergoing physiologic labor and those with labor complications. Counseling women about their risk for PPH and AMTSL is difficult as many women who appear low‐risk can still have PPH.
Methods
This study uses outcomes of 2322 vaginal births from a hospital midwifery service in the United States to examine risks for PPH and effectiveness of AMTSL. Using a latent class analysis approach, physiologic birth practices and other risk factors for PPH were analyzed to understand if discrete classes of clinical characteristics would emerge. The effect of AMTSL on the PPH outcome was also considered by class.
Results
A four‐class solution best fit the data; each class was clinically distinct. The two largest Classes (A and B) represented women with term births and lower average parity, with higher rates of nulliparity in Class B. Class A women had more physiologic birth elements and less labor induction or labor dysfunction compared with Class B. PPH and AMTSL use was higher in Class B. In Class B, AMTSL lowered risk for PPH. However, in Class A, AMTSL was associated with higher risk for PPH and delayed placental delivery (>30 minutes).
Discussion
AMTSL may not be as beneficial to women undergoing physiologic birth. Further study of the etiology of PPH in these women is indicated to inform preventive care.
Background:
Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Prophylactic uterotonic drugs can prevent PPH, and are routinely recommended. There are several uterotonic drugs for preventing PPH but it is still debatable which drug is best.
Objectives:
To identify the most effective uterotonic drug(s) to prevent PPH, and generate a ranking according to their effectiveness and side-effect profile.
Search methods:
We searched Cochrane Pregnancy and Childbirth's Trials Register (1 June 2015), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) for unpublished trial reports (30 June 2015) and reference lists of retrieved studies.
Selection criteria:
All randomised controlled comparisons or cluster trials of effectiveness or side-effects of uterotonic drugs for preventing PPH.Quasi-randomised trials and cross-over trials are not eligible for inclusion in this review.
Data collection and analysis:
At least three review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for preventing PPH ≥ 500 mL and PPH ≥ 1000 mL as primary outcomes. We performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available drugs. We stratified our primary outcomes according to mode of birth, prior risk of PPH, healthcare setting, dosage, regimen and route of drug administration, to detect subgroup effects.The absolute risks in the oxytocin are based on meta-analyses of proportions from the studies included in this review and the risks in the intervention groups were based on the assumed risk in the oxytocin group and the relative effects of the interventions.
Main results:
This network meta-analysis included 140 randomised trials with data from 88,947 women. There are two large ongoing studies. The trials were mostly carried out in hospital settings and recruited women who were predominantly more than 37 weeks of gestation having a vaginal birth. The majority of trials were assessed to have uncertain risk of bias due to poor reporting of study design. This primarily impacted on our confidence in comparisons involving carbetocin trials more than other uterotonics.The three most effective drugs for prevention of PPH ≥ 500 mL were ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination. These three options were more effective at preventing PPH ≥ 500 mL compared with oxytocin, the drug currently recommended by the WHO (ergometrine plus oxytocin risk ratio (RR) 0.69 (95% confidence interval (CI) 0.57 to 0.83), moderate-quality evidence; carbetocin RR 0.72 (95% CI 0.52 to 1.00), very low-quality evidence; misoprostol plus oxytocin RR 0.73 (95% CI 0.60 to 0.90), moderate-quality evidence). Based on these results, about 10.5% women given oxytocin would experience a PPH of ≥ 500 mL compared with 7.2% given ergometrine plus oxytocin combination, 7.6% given carbetocin, and 7.7% given misoprostol plus oxytocin. Oxytocin was ranked fourth with close to 0% cumulative probability of being ranked in the top three for PPH ≥ 500 mL.The outcomes and rankings for the outcome of PPH ≥ 1000 mL were similar to those of PPH ≥ 500 mL. with the evidence for ergometrine plus oxytocin combination being more effective than oxytocin (RR 0.77 (95% CI 0.61 to 0.95), high-quality evidence) being more certain than that for carbetocin (RR 0.70 (95% CI 0.38 to 1.28), low-quality evidence), or misoprostol plus oxytocin combination (RR 0.90 (95% CI 0.72 to 1.14), moderate-quality evidence)There were no meaningful differences between all drugs for maternal deaths or severe morbidity as these outcomes were so rare in the included randomised trials.Two combination regimens had the poorest rankings for side-effects. Specifically, the ergometrine plus oxytocin combination had the higher risk for vomiting (RR 3.10 (95% CI 2.11 to 4.56), high-quality evidence; 1.9% versus 0.6%) and hypertension [RR 1.77 (95% CI 0.55 to 5.66), low-quality evidence; 1.2% versus 0.7%), while the misoprostol plus oxytocin combination had the higher risk for fever (RR 3.18 (95% CI 2.22 to 4.55), moderate-quality evidence; 11.4% versus 3.6%) when compared with oxytocin. Carbetocin had similar risk for side-effects compared with oxytocin although the quality evidence was very low for vomiting and for fever, and was low for hypertension.
Authors' conclusions:
Ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination were more effective for preventing PPH ≥ 500 mL than the current standard oxytocin. Ergometrine plus oxytocin combination was more effective for preventing PPH ≥ 1000 mL than oxytocin. Misoprostol plus oxytocin combination evidence is less consistent and may relate to different routes and doses of misoprostol used in the studies. Carbetocin had the most favourable side-effect profile amongst the top three options; however, most carbetocin trials were small and at high risk of bias.Amongst the 11 ongoing studies listed in this review there are two key studies that will inform a future update of this review. The first is a WHO-led multi-centre study comparing the effectiveness of a room temperature stable carbetocin versus oxytocin (administered intramuscularly) for preventing PPH in women having a vaginal birth. The trial includes around 30,000 women from 10 countries. The other is a UK-based trial recruiting more than 6000 women to a three-arm trial comparing carbetocin, oxytocin and ergometrine plus oxytocin combination. Both trials are expected to report in 2018.Consultation with our consumer group demonstrated the need for more research into PPH outcomes identified as priorities for women and their families, such as women's views regarding the drugs used, clinical signs of excessive blood loss, neonatal unit admissions and breastfeeding at discharge. To date, trials have rarely investigated these outcomes. Consumers also considered the side-effects of uterotonic drugs to be important but these were often not reported. A forthcoming set of core outcomes relating to PPH will identify outcomes to prioritise in trial reporting and will inform futures updates of this review. We urge all trialists to consider measuring these outcomes for each drug in all future randomised trials. Lastly, future evidence synthesis research could compare the effects of different dosages and routes of administration for the most effective drugs.
The current specifications for the storage conditions and shelf life for oxytocin could be unnecessarily stringent, resulting in compromised access to an important commodity.
Introduction: Postpartum hemorrhage (PPH) is the first cause of maternal mortality and morbidity in developing countries. Since treatment and prevention of postpartum hemorrhage is an essential step in the health of community and specially the health of women, many studies have been conducted on the effective treatment of PPH. This study was performed with aim to systematically review the studies about the medicinal and non-medicinal treatments of PPH in Iran and the world. Methods: In this systematic review, the information was searched from databases of IRCT, Google Scholar, SID, Scopus, Pubmed and Science Direct with keywords of postpartum hemorrhage and clinical trial during 2000 to 2015. Then, the articles which obtained the score of = 3 based on Jadad criteria were entered to the study. Data were analyzed qualitatively. Results: Finally, 67 clinical trials involving 18 Iranian and 49 foreign articles which met inclusion criteria were investigated. Investigations indicated that there are very limited studies on herbal treatments while the studies on chemical treatments were numerous. Conclusion: The results showed that oxytocin is the first line treatment used in PPH due to its less side effects and the next drug is misoprostol. Further studies are needed to clarify the effect of other drugs.
Obstetrical emergencies contribute to significant morbidity and mortality in both mothers and fetuses. The major emergencies include postpartum hemorrhage, shoulder dystocia, cord prolapse, head entrapment, seizure, cardiac arrest, and perimortem cesarean delivery. Although risk factors exist for each emergency, the majority cannot be predicted. Subsequent mitigation of all obstetrical emergencies requires dedicated training, predesigned protocols, and timely multidisciplinary approaches.
Background
In settings where home birth rates are high, prenatal distribution of misoprostol has been advocated as a strategy to increase access to uterotonics during the third stage of labor to prevent postpartum hemorrhage (PPH). Our objective was to project the potential cost-effectiveness of this strategy in Uganda from both governmental (the relevant payer) and modified societal perspectives.
Methods and Findings
To compare prenatal misoprostol distribution to status quo (no misoprostol distribution), we developed a decision analytic model that tracked the delivery pathways of a cohort of pregnant women from the prenatal period, labor to delivery without complications or delivery with PPH, and successful treatment or death. Delivery pathway parameters were derived from the Uganda Demographic and Health Survey. Incidence of PPH, treatment efficacy, adverse event and case fatality rates, access to misoprostol, and health resource use and cost data were obtained from published literature and supplemented with expert opinion where necessary. We computed the expected incidence of PPH, mortality, disability adjusted life years (DALYs), costs and incremental cost effectiveness ratios (ICERs). We conducted univariate and probabilistic sensitivity analyses to examine robustness of our results. In the base-case analysis, misoprostol distribution lowered the expected incidence of PPH by 1.0% (95% credibility interval (CrI): 0.55%, 1.95%), mortality by 0.08% (95% CrI: 0.04%, 0.13%) and DALYs by 0.02 (95% CrI: 0.01, 0.03). Mean costs were higher with prenatal misoprostol distribution from governmental by US$3.3 (95% CrI: 2.1, 4.2) and modified societal (by US$1.3; 95% CrI: -1.6, 2.8) perspectives. ICERs were US$191 (95% CrI: 82, 443) per DALY averted from a governmental perspective, and US$73 (95% CI: -86, 256) per DALY averted from a modified societal perspective.
Conclusions
Prenatal distribution of misoprostol is potentially cost-effective in Uganda and should be considered for national-level scale up for prevention of PPH.
Postpartum haemorrhage (PPH) is a major cause of maternal mortality, accounting for one-quarter of all maternal deaths worldwide. Uterotonics after birth are the only intervention that has been shown to be effective for PPH prevention. Tranexamic acid (TXA), an antifibrinolytic agent, has therefore been investigated as a potentially useful complement to this for both prevention and treatment because its hypothesized mechanism of action in PPH supplements that of uterotonics and because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. This review covers evidence from randomized controlled trials (RCTs) for PPH prevention after caesarean (n=10) and vaginal (n=2) deliveries and for PPH treatment after vaginal delivery (n=1). It discusses its efficacy and side effects overall and in relation to the various doses studied for both indications. TXA appears to be a promising drug for the prevention and treatment of PPH after both vaginal and caesarean delivery. Nevertheless, the current level of evidence supporting its efficacy is insufficient, as are the data about its benefit:harm ratio. Large, adequately powered multicentre RCTs are required before its widespread use for preventing and treating PPH can be recommended.
© The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
Décrire les méthodes de prévention clinique et pharmacologique de l’hémorragie du post-partum (HPP).
Background:
Active management of the third stage of labour has been shown to reduce the risk of postpartum haemorrhage (PPH) greater than 1000 mL. One aspect of the active management protocol is the administration of prophylactic uterotonics, however, the type of uterotonic, dose, and route of administration vary across the globe and may have an impact on maternal outcomes.
Objectives:
To determine the effectiveness of prophylactic oxytocin at any dose to prevent PPH and other adverse maternal outcomes related to the third stage of labour.
Search methods:
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2013).
Selection criteria:
Randomised or quasi-randomised controlled trials including pregnant women anticipating a vaginal delivery where prophylactic oxytocin was given during management of the third stage of labour. The primary outcomes were blood loss > 500 mL and the use of therapeutic uterotonics.
Data collection and analysis:
Two review authors independently assessed trials for inclusion, assessed trial quality and extracted data. Data were checked for accuracy.
Main results:
This updated review included 20 trials (involving 10,806 women). Prophylactic oxytocin versus placebo Prophylactic oxytocin compared with placebo reduced the risk of PPH greater than 500 mL, (risk ratio (RR) 0.53; 95% confidence interval (CI) 0.38 to 0.74; six trials, 4203 women; T² = 0.11, I² = 78%) and the need for therapeutic uterotonics (RR 0.56; 95% CI 0.36 to 0.87, four trials, 3174 women; T² = 0.10, I² = 58%). The benefit of prophylactic oxytocin to prevent PPH greater than 500 mL was seen in all subgroups. Decreased use of therapeutic uterotonics was only seen in the following subgroups: randomised trials with low risk of bias (RR 0.58; 95% CI 0.36 to 0.92; three trials, 3122 women; T² = 0.11, I² = 69%); trials that performed active management of the third stage (RR 0.39; 95% CI 0.26 to 0.58; one trial, 1901 women; heterogeneity not applicable); trials that delivered oxytocin as an IV bolus (RR 0.57; 95% CI 0.39 to 0.82; one trial, 1000 women; heterogeneity not applicable); and in trials that gave oxytocin at a dose of 10 IU (RR 0.48; 95% CI 0.33 to 0.68; two trials, 2901 women; T² = 0.02, I² = 27%). Prophylactic oxytocin versus ergot alkaloids. Prophylactic oxytocin was superior to ergot alkaloids in preventing PPH greater than 500 mL (RR 0.76; 95% CI 0.61 to 0.94; five trials, 2226 women; T² = 0.00, I² = 0%). The benefit of oxytocin over ergot alkaloids to prevent PPH greater than 500 mL only persisted in the subgroups of quasi-randomised trials (RR 0.71, 95% CI 0.53 to 0.96; three trials, 1402 women; T² = 0.00, I² = 0%) and in trials that performed active management of the third stage of labour (RR 0.58; 95% CI 0.38 to 0.89; two trials, 943 women; T² = 0.00, I² = 0%). Use of prophylactic oxytocin was associated with fewer side effects compared with use of ergot alkaloids; including decreased nausea between delivery of the baby and discharge from the labour ward (RR 0.18; 95% CI 0.06 to 0.53; three trials, 1091 women; T² = 0.41, I² = 41%) and vomiting between delivery of the baby and discharge from the labour ward (RR 0.07; 95% CI 0.02 to 0.25; three trials, 1091 women; T² = 0.45, I² = 30%). Prophylactic oxytocin + ergometrine versus ergot alkaloids: There was no benefit seen in the combination of oxytocin and ergometrine versus ergometrine alone in preventing PPH greater than 500 mL (RR 0.90; 95% CI 0.34 to 2.41; five trials, 2891 women; T² = 0.89, I² = 80%). The use of oxytocin and ergometrine was associated with increased mean blood loss (MD 61.0 mL; 95% CI 6.00 to 116.00 mL; fixed-effect analysis; one trial, 34 women; heterogeneity not applicable).In all three comparisons, there was no difference in mean length of the third stage or need for manual removal of the placenta between treatment arms.
Authors' conclusions:
Prophylactic oxytocin at any dose decreases both PPH greater than 500 mL and the need for therapeutic uterotonics compared to placebo alone. Taking into account the subgroup analyses from both primary outcomes, to achieve maximal benefit providers may opt to implement a practice of giving prophylactic oxytocin as part of the active management of the third stage of labour at a dose of 10 IU given as an IV bolus. If IV delivery is not possible, IM delivery may be used as this route of delivery did show a benefit to prevent PPH greater than 500 mL and there was a trend to decrease the need for therapeutic uterotonics, albeit not statistically significant.Prophylactic oxytocin was superior to ergot alkaloids in preventing PPH greater than 500 mL; however, in subgroup analysis this benefit did not persist when only randomised trials with low risk of methodologic bias were analysed. Based on this, there is limited high-quality evidence supporting a benefit of prophylactic oxytocin over ergot alkaloids. However, the use of prophylactic oxytocin was associated with fewer side effects, specifically nausea and vomiting, making oxytocin the more desirable option for routine use to prevent PPH.There is no evidence of benefit when adding oxytocin to ergometrine compared to ergot alkaloids alone, and there may even be increased harm as one study showed evidence that using the combination was associated with increased mean blood loss compared to ergot alkaloids alone.Importantly, there is no evidence to suggest that prophylactic oxytocin increases the risk of retained placenta when compared to placebo or ergot alkaloids.More placebo-controlled, randomised, and double-blinded trials are needed to improve the quality of data used to evaluate the effective dose, timing, and route of administration of prophylactic oxytocin to prevent PPH. In addition, more trials are needed especially, but not only, in low- and middle-income countries to evaluate these interventions in the birth centres that shoulder the majority of the burden of PPH in order to improve maternal morbidity and mortality worldwide.
To evaluate whether sustained transabdominal uterine massage can reduce blood loss after vaginal delivery.
In this multicenter randomized controlled trial, eligible women who had delivered vaginally were randomly assigned to receive 10 units oxytocin intramuscularly immediately after delivery of the shoulder plus 30 minutes of sustained transabdominal uterine massage after delivery of the placenta or to 10 units oxytocin intramuscularly alone. The primary outcome was blood loss of 400 mL or more in the 2 hours after delivery of the neonate. Secondary outcomes included blood loss of 1,000 mL or more, blood loss in the 2 hours after delivery, use of therapeutic uterotonics or other hemostatic procedures, hemoglobin of lower than 80 g/L before discharge, and need for blood transfusion. Analysis was by intent to treat. With a one-sided α of 0.05 and a power of 0.8, a sample size of 1,061 women per group was calculated to detect a 3% absolute decrease in the primary outcome.
Of 2,340 eligible women, 1,170 were randomized to oxytocin plus uterine massage and 1,170 to the oxytocin-only group. Baseline characteristics were similar in both groups. The incidence of blood loss of 400 mL or more in the 2 hours after delivery was not significantly different between the two groups (143/1,170 [12.2%] compared with 144/1,170 [12.3%]; relative risk 0.99, 95% confidence interval 0.88-1.13) according to intent-to-treat analysis with a power of more than 0.8. No significant differences were found in the secondary outcomes.
In patients delivered vaginally, transabdominal uterine massage after delivery of the placenta in addition to oxytocin does not reduce blood loss when compared with administration of oxytocin alone.
Chinese Clinical Trial Registry, www.chictr.org, ChiCTR-TRC-11001763.
: I.
The global burden of maternal and infant deaths falls disproportionately on low income countries (LICs) and lower middle income countries (LMCs) and among the poorest within these countries. Urban growth is changing population health, particularly among the urban poor. The number of births taking place in urban areas in LICs and LMCs is increasing; services must accommodate this because large populations and high population density in urban areas influence options for service organisation. It is crucial to establish evidence-based ways of improving models of service delivery and access to and uptake of maternal and infant care. This systematic review addresses the question: ‘What are the effects of different models of delivery for improving maternal and infant health outcomes for poor people in urban areas in low income and lower middle income countries?’
Postpartum haemorrhage (PPH) (bleeding from the genital tract after childbirth) is a major cause of maternal mortality and disability, particularly in under-resourced areas. In these settings, poor nutrition, malaria and anaemia may aggravate the effects of PPH. In addition to the standard known strategies to prevent and treat PPH, there is a need for simple, non-expensive techniques which can be applied in low-resourced settings to prevent or treat PPH.
To determine the effectiveness of uterine massage after birth and before or after delivery of the placenta, or both, to reduce postpartum blood loss and associated morbidity and mortality.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2008), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2007, Issue 2) and PubMed (1966 to June 2007).
All published, unpublished and ongoing randomised controlled trials comparing uterine massage alone or in addition to uterotonics before or after delivery of the placenta, or both, to non-massage.
Both authors extracted the data independently using the agreed form.
One randomised controlled trial in which 200 women were randomised to receive uterine massage or no massage after active management of the third stage of labour. The numbers of women with blood loss more than 500 ml was small, with wide confidence intervals and no statistically significant difference (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.16 to 1.67). There were no cases of retained placenta in either group. The mean blood loss was less in the uterine massage group at 30 minutes (mean difference (MD) -41.60, 95% CI -75.16 to -8.04) and 60 minutes after enrolment (MD -77.40, 95% CI -118.71 to -36.09 ml) . The need for additional uterotonics was reduced in the uterine massage group (RR 0.20, 95% CI 0.08 to 0.50). Two blood transfusions were administered in the control group.
The present review adds support to the 2004 joint statement of the International Confederation of Midwives and the International Federation of Gynaecologists and Obstetricians on the management of the third stage of labour, that uterine massage after delivery of the placenta is advised to prevent PPH. However, due to the limitations of the one trial reviewed, trials with sufficient numbers to estimate the effects of sustained uterine massage with great precision, both with and in the absence of uterotonics, are needed.
Background:
Postpartum haemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labour, including use of a uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. We did a multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour.
Methods:
In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, we randomly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labour. The primary outcomes were measured postpartum blood loss of 1000 mL or more, and the use of additional uterotonics without an unacceptable level of side-effects. We chose an upper limit of a 35% increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat.
Findings:
9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 mL or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% CI 1.19-1.63], p<0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p<0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15-3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery.
Interpretation:
10 IU oxytocin (intravenous or intramuscular) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital settings where active management is the norm.
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity worldwide. Uterine massage is thought to stimulate uterine contraction possibly through stimulation of local prostaglandin release and thus to reduce hemorrhage. The objective of the randomized trial reported here was to determine the effectiveness of intermittent uterine massage after delivery of the placenta to reduce postpartum blood loss and the need for additional uterotonics. The study was conducted in the labor ward of the Department of Obstetrics and Gynecology Assiut University Hospital during June and July 2005. (excerpt)
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