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Pain management for medical abortion before 14 weeks' gestation
Abstract
Background:
Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks' gestation. OBJECTIVES: Primary objective To determine if there is evidence of superiority of any particular pain relief regimen in the management of combination medical abortion (mifepristone + misoprostol) under 14 weeks' gestation (i.e. up to 13 + 6 weeks or 97 days). Secondary objectives To compare the rate of gastrointestinal side effects resulting from different methods of analgesia To compare the rate of complete abortion resulting from different methods of analgesia during medical abortion To determine if the induction-to-abortion interval is associated with different methods of analgesia To determine if any method of analgesia is associated with unscheduled contact with the care provider in relation to pain.
Search methods:
On 21 August 2019 we searched CENTRAL, MEDLINE, Embase, CINAHL, LILACs, PsycINFO, the World Health Organization International Clinical Trials Registry and ClinicalTrials.gov together with reference checking and handsearching of conference abstracts of relevant learned societies and professional organisations to identify further studies.
Selection criteria:
We included randomised controlled trials (RCTs) and observational studies (non-randomised studies of interventions (NRSIs)) of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks' gestation.
Data collection and analysis:
Two review authors (JRW and MA) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion with a third and fourth author as required (CM and SC). Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked for accuracy. We assessed the certainty of the evidence using the GRADE approach.
Main results:
We included four RCTs and one NRSI. Due to the heterogeneity of study designs, interventions and outcome reporting, we were unable to perform meta-analysis for any of the primary or secondary outcomes in this review. Only one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600 mg likely reduces the pain score when compared to a dose of paracetamol 2000 mg (mean difference (MD) 2.26 out of 10 lower, 95% confidence interval (CI) 3.00 to 1.52 lower; 1 RCT 108 women; moderate-certainty evidence). There may be little to no difference in pain score when comparing pregabalin 300 mg with placebo (MD 0.5 out of 10 lower, 95% CI 1.41 lower to 0.41 higher; 1 RCT, 107 women; low-certainty evidence). There may be little to no difference in pain score when comparing ibuprofen 800 mg with placebo (MD 1.4 out of 10 lower, 95% CI 3.33 lower to 0.53 higher; 1 RCT, 61 women; low-certainty evidence). Ambulation or non-ambulation during medical abortion treatment may have little to no effect on pain score, but the evidence is very uncertain (MD 0.1 out of 5 higher, 95% CI 0.26 lower to 0.46 higher; 1 NRSI, 130 women; very low-certainty evidence). There may be little to no difference in pain score when comparing therapeutic versus prophylactic administration of ibuprofen 800 mg (MD 0.2 out of 10 higher, 95% CI 0.41 lower to 0.81 higher; 1 RCT, 228 women; low-certainty evidence). Other outcomes of interest were reported inconsistently across studies. Where these outcomes were reported, there was no evidence of difference in incidence of gastrointestinal side effects, complete abortion rate, interval between misoprostol administration to pregnancy expulsion, unscheduled contact with a care provider, patient satisfaction with analgesia regimen nor patient satisfaction with abortion experience overall. However, the certainty of evidence was very low to low.
Authors' conclusions:
The findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600 mg was shown to be effective, and it was less certain whether 800 mg was effective. Paracetamol 2000 mg does not improve pain scores as much as ibuprofen 1600 mg, however its use does not appear to cause greater frequency of side effects or reduce the success of the abortion. A single dose of pregabalin 300 mg does not affect pain scores during medical abortion, but like paracetamol, does not appear to cause harm. Ambulation or non-ambulation during the medical abortion procedure does not appear to affect pain scores, outcomes, or duration of treatment and so women can be advised to mobilise or not, as they wish. The majority of outcomes in this review had low- to very low-certainty evidence, primarily due to small sample sizes and two studies at high risk of bias. High-quality, large-scale RCT research is needed for pain management during medical abortion at gestations less than 14 weeks. Consistent recording of pain with a validated measure would be of value to the field going forward.
... I do think I would have liked more information about [it]. (38) I'd read about [surgical abortion], but it kind of sounded like they didn't [. . .] it didn't really seem like it was getting offered to me as an option. ...
... .] it was killing me', (29) felt like 'giving birth'. (31,38) In many cases, women felt unprepared for the level of pain they experienced: 'I can't remember exactly but it I'm pretty sure it was like, 'it [paracetamol and ibuprofen] should ease the discomfort' [. . .] [while] I remember thinking at the time, I'd rather be dead than feel this pain'. ...
... 36 Reports of severe pain among women in our study are in line with the estimates of between half and three-quarters of such patients reporting moderate to high levels of pain. 37,38,39,40,41 The effectiveness of any pain-management strategy will depend in large part on how prepared patients are to anticipate requiring its use. The non-use of the offered analgesia by some women in our study is consistent with the findings of studies showing ineffective use of painkillers during home-managed medical abortion: nearly 25% used no analgesia at all. ...
Background
Models of abortion care have changed significantly in the last decade, most markedly during the COVID-19 pandemic, when home management of early medical abortion with telemedical support was approved in Britain.
Objective
Our study aimed to examine women’s satisfaction with abortion care and their suggestions for improvements.
Design
Qualitative, in-depth, semi-structured interviews.
Methods
A purposive sample of 48 women with recent experience of abortion was recruited between July 2021 and August 2022 from independent sector and National Health Service abortion services in Scotland, Wales and England. Interviews were conducted by phone or via video call. Women were asked about their abortion experience and for suggestions for any improvements that could be made along their patient journey – from help-seeking, the initial consultation, referral, treatment, to aftercare. Data were analyzed using the Framework Method.
Results
Participants were aged 16–43 years; 39 had had a medical abortion, 8 a surgical abortion, and 1 both. The majority were satisfied with their clinical care. The supportive, kind and non-judgmental attitudes of abortion providers were highly valued, as was the convenience afforded by remotely supported home management of medical abortion. Suggestions for improvement across the patient journey centred around the need for timely care; greater correspondence between expectations and reality; the importance of choice; and the need for greater personal and emotional support.
Conclusion
Recent changes in models of care present both opportunities and challenges for quality of care. The perspectives of patients highlight further opportunities for improving care and support. The principles of timely care, choice, management of expectations, and emotional support should inform further service configuration.
... Several studies support non-steroidal anti-inflammatories as treatment for women undergoing abortion procedures; acetaminophen (paracetamol), however, has not been found effective in reducing pain. 12,13 A recent study indicates that the majority of women need analgesics in addition to prophylactic pain medication. 10 Alongside the experience of severe pain, inadequate pain management during the abortion has been reported by women. ...
... Some studies suggest that high doses of non-steroidal anti-inflammatory drugs (NSAIDs), such as 800-1600 mg Ibuprofen, may be effective in managing pain for women undergoing abortion procedures, while acetaminophen (paracetamol) has not been found to be effective. 12,13,24,25 However, there is limited knowledge on effective pain management for abortion pain, indicating a need for further research. 10,13 The participants in our study not only found the pain to be more severe, but also essentially different in quality, than menstruation cramps. ...
... 12,13,24,25 However, there is limited knowledge on effective pain management for abortion pain, indicating a need for further research. 10,13 The participants in our study not only found the pain to be more severe, but also essentially different in quality, than menstruation cramps. Many of the women experienced the abortion as painful contractions similar to or worse than giving birth at full term. ...
Introduction
Medical abortion has rapidly become the dominant abortion method in western countries. Pain is a known adverse effect; however, few studies have explored women’s subjective experience of medical abortion pain.
Purpose
To explore Norwegian women’s experiences of pain when performing a medical abortion at home.
Material and Methods
We recruited 24 women through an advertisement on Facebook and conducted semi-structured, face-to-face interviews. The interviews were transcribed verbatim and the data were analyzed using a phenomenological hermeneutical method.
Results
Our findings consisted of two main themes: 1) Being in pain or becoming pain, and 2) Being caught off guard and struggling to cope. Participants described undergoing severe pain, comparable to giving birth, during the medical abortion. Unprepared for the type and intensity of the pain, they felt anxious and insecure. Pain is physical, but it also has important psychological, social, and existential dimensions. Our culture (in)forms our thoughts and feelings about our pain, affecting our ability to endure suffering. The participants’ experiences of abortion pain prompt timely questions concerning gendered socio-cultural and existential meanings connected to pain, specifically in relation to female reproductive functions.
Conclusion
Women need realistic information about the type and intensity of abortion pain, as well as evidence-based pain medication. Psychological factors may affect the experience of abortion pain and should therefore be taken into account in abortion care.
... Studies have yet to identify the best way to manage pain. 2 Trials show patients typically experience moderate to severe pain, with average pain scores between 5 and 8 out of 10. [3][4][5] For many, pain is the worst feature of this method. 6 Dissatisfaction with medical abortion at home is associated with dissatisfaction with pain control. ...
Objective
To explore experiences of pain during medical abortion and provide patient-centred recommendations for improving abortion experience and pain counselling.
Methods
We invited patients of British Pregnancy Advisory Service who underwent medical abortion up to 10 weeks’ gestation to participate in an online, English language questionnaire from November 2021 to March 2022. Participants answered questions about pain, method preference, abortion experience, advice, and how they would describe pain experienced to a friend. In this secondary analysis, we analysed free-text responses using reflexive thematic analysis techniques. We used descriptive statistics and parametric tests to analyse quantitative responses.
Results
Of 11 906 patients invited to participate, 1596 (13.4%) completed the questionnaire, including at least one free-text comment. Participants used a range of descriptors for medical abortion pain across three broad themes: pain severity, pain quality and comparisons to other reproductive pain. Some found the commonly used analogy to period pain misleading. Many felt unprepared for the level of pain they experienced, which they attributed to provider comparisons to period pain, as well as a lack of detailed, realistic anticipatory pain counselling. Qualitative and quantitative results suggest pain experiences impact method preference. Participants recommended better counselling for pain and abortion preparation, including first-hand accounts of medical abortion at home and a wide and accessible range of descriptions of pain.
Conclusions
Abortion providers should use patient-centred recommendations to better prepare patients for pain during medical abortion. Setting realistic expectations can improve abortion experience and support informed method choice. Further research is needed to develop and test patient-centred counselling materials.
... Taking misoprostol may be associated with side effects such as vomiting, diarrhea, bleeding, abdominal pain, fever, and chills; the severity and recurrence of these side effects depend on the route of administration, dose, and time interval between doses [3]. Therefore, it seems necessary to find a way to better tolerate this drug and thus make it more effective and safer [6]. Herbal medicines are non-invasive, safer and less expensive than chemical medicines [7]. ...
Abstract Background Misoprostol is the choice drug for inducing an abortion with intrauterine fetal death, but it has several side effects that increase with accumulating the dose received. Induction abortion with cheap and non-invasive methods with minimal complications is essential. This study aimed to compare the effect vaginal misoprostol plus vaginal evening primrose oil capsule with vaginal misoprostol alone on the consequences of abortion in pregnant women with intrauterine fetal death at 12–20 weeks of pregnancy. Methods This study is a randomized, triple-blind clinical trial with two parallel groups at a ratio of 1:1. We randomized 82 women with indications of termination of pregnancy due to intrauterine fetal death into two groups. The experimental group (n = 42) received 200 mcg of misoprostol tablet with 1000 mg evening primrose oil capsule intravaginal. The control group (n = 40) received 200 mcg of misoprostol tablet with 1000 mg evening primrose oil placebo capsule intravaginal. Both groups received the drugs every 4 h for up to five doses. The primary outcome was the mean induction-to-fetal expulsion interval. Secondary outcomes were the mean dose of misoprostol, the highest pain intensity in the induction-to-fetal expulsion interval, the frequency of participants requiring blood transfusion, curettage, and the frequency of side effects of misoprostol or evening primrose oil. Pain intensity was measured through the Visual Analog Scale. Results The mean age of the experimental group was 32.30 ± 6.19 years, and the control group was 30.27 ± 7.68 years. The mean gestational age of the experimental group was 15.29 ± 2.26 weeks, and the control group was 15.10 ± 1.89 weeks. The mean induction-to-fetal expulsion interval in the experimental group (3.12 ± 2.17 h) was significantly lower than that in the control group (8.40 ± 4.1 h) (p
... There is no consensus within the literature on analgesia for those who experience pain during medical abortion although a Cochrane Review is currently in progress on this topic. 74 There is currently significant variation in practice described in terms of the analgesics offered, the schedule and route of administration and whether these are provided by health services. ...
Objective
To inform UK service development to support medical abortion at home, appropriate for person and context.
Design
Realist review
Setting/participants
Peer-reviewed literature from 1 January 2000 to 9 December 2021, describing interventions or models of home abortion care. Participants included people seeking or having had an abortion.
Interventions
Interventions and new models of abortion care relevant to the UK.
Outcome measures
Causal explanations, in the form of context-mechanism-outcome configurations, to test and develop our realist programme theory.
Results
We identified 12 401 abstracts, selecting 944 for full text assessment. Our final review included 50 papers. Medical abortion at home is safe, effective and acceptable to most, but clinical pathways and user experience are variable and a minority would not choose this method again. Having a choice of abortion location remains essential, as some people are unable to have a medical abortion at home. Choice of place of abortion (home or clinical setting) was influenced by service factors (appointment number, timing and wait-times), personal responsibilities (caring/work commitments), geography (travel time/distance), relationships (need for secrecy) and desire for awareness/involvement in the process. We found experiences could be improved by offering: an option for self-referral through a telemedicine consultation, realistic information on a range of experiences, opportunities to personalise the process, improved pain relief, and choice of when and how to discuss contraception.
Conclusions
Acknowledging the work done by patients when moving medical abortion care from clinic to home is important. Patients may benefit from support to: prepare a space, manage privacy and work/caring obligations, decide when/how to take medications, understand what is normal, assess experience and decide when and how to ask for help. The transition of this complex intervention when delivered outside healthcare environments could be supported by strategies that reduce surprise or anxiety, enabling preparation and a sense of control.
Objective
To assess patient experiences of pain management during medical abortion up to 10 weeks’ gestation with opt-in versus universal codeine provision.
Methods
We invited patients who underwent medical abortion up to 10 weeks of gestation to participate in an online, anonymous, English-language survey from November 2021 to March 2022. We performed ordinal regression analyses to compare satisfaction with pain management (5-point Likert scale) and maximum abortion pain score (11-point numerical rating scale) in the opt-in versus universal codeine provision groups.
Results
Of 11 906 patients invited to participate, 1625 (13.6%) completed the survey. Participants reported a mean maximum pain score of 6.8±2.2. A total of 1149 participants (70.7%) reported using codeine for pain management during their abortion. Participants in the opt-in codeine provision group were significantly more likely to be satisfied with their pain management than those in the universal group (aOR 1.48, 95% CI 1.12 to 1.96, p<0.01). Maximum abortion pain scores were lower on average among the opt-in codeine provision group (OR 0.80, 95% CI 0.66 to 0.96, p=0.02); however, this association was not statistically significant in the model adjusted for covariates (aOR 0.85, 95% CI 0.70 to 1.03, p=0.09).
Conclusion
Our findings suggest that patients have a better experience with pain management during medical abortion when able to opt-in to codeine provision following counselling versus receiving this medication routinely.
Both medication and procedural abortion are associated with pain. The experiences of pain depend on both physical and emotional factors. Several pain management options are available for abortion, depending on abortion type, clinical setting, and patient considerations, and a comprehensive approach is necessary to optimize pain management.
Objective:
To explore patient perspectives regarding patient-clinician communication during telemedicine medication abortion compared with traditional, facility based, in-clinic visits.
Methods:
We conducted semi-structured interviews with participants who received either live, face-to-face telemedicine or in-clinic medication abortion from a large, reproductive health care facility in Washington State. Using Miller's conceptual framework for patient-doctor communication in telemedicine settings, we developed questions exploring participants' experiences of the medication abortion consultation, including the clinician's verbal and nonverbal interpersonal approach and communication of relevant medical information, and the setting where care was received. We used inductive-deductive constant comparative analysis to identify major themes. We summarize patient perspectives using patient-clinician communication terms outlined in Dennis' quality abortion care indicator list.
Results:
Thirty participants completed interviews (aged 20-38 years), 20 of whom had medication abortion by telemedicine and 10 who received in-clinic services. Participants who received telemedicine abortion services reported high-quality patient-clinician communication, which came from their freedom to choose their consultation location, and reported feeling more relaxed during clinical encounters. In contrast, most in-clinic participants portrayed their consultations as lengthy, chaotic, and lacking comfort. In all other domains, both telemedicine and in-clinic participants reported similar levels of interpersonal connection to their clinicians. Both groups appreciated medical information about how to take the abortion pills and relied heavily on clinic-based printed materials and independent online resources to answer questions during the at-home termination process. Both telemedicine and in-clinic participant groups were highly satisfied with their care.
Conclusion:
Patient-centered communication skills used by clinicians during facility based, in-clinic care translated well to the telemedicine setting. However, we found that patients who received medication abortion through telemedicine favorably ranked their patient-clinician communication overall as compared with those in traditional, in-clinic settings. In this way, telemedicine abortion appears to be a beneficial patient-centered approach to this critical reproductive health service.
Objective
Few studies have investigated the features associated with pain levels during abortion. We aimed to investigate the risk factors for experiencing pain during medication abortion, focusing on women's psychological distress and anxiety levels.
Study design
We carried out this observational study at two centers in Bologna, Italy. We included women aged 18 years or more with a viable intrauterine pregnancy of up to 63 days of amenorrhea, who chose medication abortion. Women received 600 mg of Mifepristone orally and after 48 hours 400 mcg of buccal misoprostol, repeated after 3 hours according to local and regional medication abortion guidelines, as well as prophylactic analgesia. We evaluated the clinical characteristics which may represent risk factors for severe pain (Visual Analogue Scale [VAS] ≥ 70) through a multivariate model.
Results
Two hundred forty-two patients were included in our analysis; 92 (38.0%) reported severe pain during medication abortion. Women with higher baseline anxiety levels (General Health Questionnaire 12 score ≥ 6 and General Anxiety Disorder 7 score ≥ 10) had a higher probability of experiencing pain with a VAS ≥70 (OR = 3.33, 95% CI 1.43–7.76), as well as those who reported dysmenorrhea in the past year (OR = 6.30, 95% CI 2.66–14.91). Previous vaginal deliveries were inversely correlated with pain intensity (OR 0.26, 95% CI 0.14 – 0.50).
Conclusion
Increased baseline anxiety levels, dysmenorrhea and no previous vaginal deliveries are associated with severe pain in women undergoing medication abortion.
Implications
The identification of women at risk for severe pain based on clinical and historical factors as well as the definition of an adequate analgesic regimen may help to improve women's care and pain management during medication abortion.
Résumé
Objectif: L’objectif principal était de comparer l’efficacité de la dose unique de misoprostol entre les interruptions volontaires de grossesse réalisées avant 7 semaines d’aménorrhée et entre 7 et 9 semaines d’aménorrhée. Les objectifs secondaires étaient de comparer la quantité de misoprostol nécessaire pour expulsion complète, la nécessité de recours à une aspiration endo utérine, d’évaluer les douleurs et le vécu des patientes dans ces deux groupes.
Méthode: Il s’agissait d’une étude prospective observationnelle monocentrique réalisée aux Hôpitaux Universitaires de Strasbourg du 1er octobre 2019 au 31 décembre 2020.
Résultats: Au total, 306 patientes ont été incluses dont 150 dans le groupe avant 7 semaines d’aménorrhée et 156 dans le groupe entre 7 et 9 semaines d’aménorrhée. Il n’y avait pas de différence significative concernant le taux de réussite de la dose unique de misoprostol entre les deux groupes avec respectivement 34,7 et 37,8 % (p=0,63). Après prise d’antalgiques, il n’y avait pas de différence significative entres les deux groupes concernant le soulagement de la douleur (EN≤4 chez 92 et 95% des patientes p=0,37).
Conclusions: La dose unique de misoprostol pour les interruptions volontaires de grossesse réalisée en milieu hospitalier est aussi efficace entre 7 et 9 semaines d’aménorrhée qu’avant 7 semaines d’aménorrhée. Par extension, nous pourrions donc penser qu’il ne devrait pas y avoir de différence d’efficacité entre les interruptions volontaires de grossesse à domicile avant 7 semaines d’aménorrhée et entre 7 et 9 semaines d’aménorrhée et suggérons donc que les IVG à domicile peuvent être réalisées jusqu’à 9 SA sans craindre une diminution du taux d’expulsion complète et de l’efficacité de l’antalgie avec potentiellement un moindre recours au misoprostol comparé au milieu hospitalier.
Introduction
Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks’ gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks’ gestation.
Methods
We conducted our search in August 2019 and included randomized controlled trials (RCT) and observational studies of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks’ gestation.
Results
We included four RCTs and one observational study. Due to the heterogeneity of study designs, interventions and outcome reporting, meta-analysis was not possible.
Only one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600mg likely reduces the pain score when compared to a dose of paracetamol 2000mg (MD 2.26/10 [CI 3-1.52 lower]).
For other interventions (pregabalin 300mg vs placebo; ibuprofen 800mg vs placebo; therapeutic vs prophylactic administration of ibuprofen 800mg; ambulation vs non-ambulation during treatment) there appeared to be little to no difference with comparator.
Conclusions
The findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600mg was shown to be effective and it was less certain whether 800mg was effective.
Background
The Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we provided self-administered medications to eligible women with pregnancies under 12 weeks’ gestation.
Aims
To assess adherence to the recommended abortion drug regimen, with particular focus on the number of misoprostol doses used and the interval between mifepristone and misoprostol administration and the induction–expulsion interval. Additionally, to evaluate use of analgesia, antiemetics and antibiotics, and the side effects, pain and bleeding profile of medical abortion at home.
Methods
We conducted a prospective cohort study of 663 women choosing medical abortion at home via telemedicine at an NHS abortion service in Edinburgh, Scotland between 1 April and 9 July 2020. Interviewer-administered questionnaires were completed at telephone follow-up 4 and 14 days following treatment. Outcome measures were self-reported and included use of mifepristone and misoprostol, induction–expulsion interval (time from misoprostol administration until expulsion of pregnancy), antiemetics, antibiotics, analgesia use, pain scores, rates of side effects, bleeding and preparedness for treatment.
Results
Among the respondents, 652/663 women (98%) answered at least one questionnaire, and 594/663 (89.6%) used both abortion medications as directed (24–72 hours between medications). The mean (SD) induction–expulsion interval was 4.3 (4.3) hours. Antiemetics were used by 611/663 (92%), 383/599 (64%) completed the course of prophylactic antibiotics, and 616/663 (93%) used analgesia, with mean (SD) worst-pain scores of 6.7 (2.2) out of 10. Regarding side effects, 510/663 (77%) experienced either nausea, vomiting, diarrhoea or headache, 101/663 (15%) experienced headache and 510/663 (77%) experienced bleeding that was heavier than a period; 554/663, (84%) felt prepared for their treatment by teleconsultation.
Conclusion
Patients are able to correctly self-administer abortion medications following a telemedicine consultation. Further research is required to optimise pain management and gastrointestinal side effects during medical abortion.
The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
Despite a major increase in the range and number of software offerings now available to help researchers produce evidence syntheses, there is currently no generic tool for producing figures to display and explore the risk‐of‐bias assessments that routinely take place as part of systematic review. However, tools such as the R programming environment and Shiny (an R package for building interactive web apps) have made it straightforward to produce new tools to help in producing evidence syntheses. We present a new tool, robvis (Risk‐Of‐Bias VISualization), available as an R package and web app, which facilitates rapid production of publication‐quality risk‐of‐bias assessment figures. We present a timeline of the tool’s development and its key functionality.
This article is protected by copyright. All rights reserved.
Objective:
To assess the safety and acceptability of abortion through telemedicine > 9 (9+0) gestational weeks (gw).
Design:
Cohort study.
Setting:
Poland.
Population:
615 women who requested and performed abortion through telemedicine June 1st- December 31st 2016.
Methods:
Risks of adverse outcomes were calculated as adjusted odds ratios (OR) with 95% confidence intervals (CI) by unconditional logistic regression according to gestational age at abortion ≤ or > 9 gw.
Main outcome measures:
Self-reported hospital visits for concerns related to the abortion within 0-1 days of the abortion, heavy bleeding, pain and bleeding more than expected and low satisfaction.
Results:
Among women ≤ 9gw and >9gw, 3.3% vs 11.7% went to hospital for concerns within 0-1 days of the abortion (AOR 3.82, 95% CI 1.90-7.69). Among women 11w+1d-14w+2d the rate was 22.5% (AOR 9.20, 95% CI 3.58-23.60). Among women ≤ 9gwand > 9 gw, the rate of heavy bleeding was 6.8% vs 10.1% (AOR 1.65, 95% CI 0.90-3.04), the rate of low satisfaction was 2.4% vs 1.6% (AOR 0.69, 95% CI 0.14-3.36), the rate of bleeding more than expected was 45.6% vs 57.8% (AOR 1.26, 95% CI 0.78-2.02), and the rate of pain more than expected was 35.6% vs 38.8% (AOR 1.11, 95% CI 0.71-1.71).
Conclusions:
Medical abortion through telemedicine >9 gw is associated with a higher risk of same-day or day-after hospital visits for concerns related to the procedure and this risk increases with gestational age. Self-reported rates of heavy bleeding, low satisfaction or unmet expectations with medical abortion do not increase with gestational age. This article is protected by copyright. All rights reserved.
Bakgrunn. I Norge utføres abort kun i offentlige sykehus. I 2010 besluttet Helse- og
omsorgsdepartementet å iverksette et toårig prøveprosjekt som ga avtalespesialister i
fødselshjelp og kvinnesykdommer adgang til å tilby medikamentell abort før utgangen av
9. svangerskapsuke. Prøveprosjektet ble igangsatt 1.3.2015 og varte til 31.3.2017. I denne
artikkelen presenterer vi de første erfaringene, herunder hvordan behandlingstilbudet ble
mottatt av kvinnene.
Materiale og metode. Gravide med en svangerskapsvarighet < 63 dager ultrasonografisk vurdert, som oppsøkte avtalespesialist for medikamentell abort, ble fortløpende inkludert i prosjektet (n = 476). Kvinnene inntok 200 mg mifepriston peroralt på legekontoret, 36–48 timer senere satte de selv 800 μg misoprostol vaginalt hjemme. Informasjon ble innhentet ved spørreskjema på den første konsultasjonen, under aborten og ved etterkontrollen 2–4 uker etter aborten.
Resultater. Under aborten rapporterte 66 % (296/450) moderat eller sterk smerte og 79 % (358/451) moderat eller sterk blødning. De fleste opplevde det som trygt å være hjemme. 96 % (390/406) ville valgt medikamentell abort hos avtalespesialist ved en eventuell senere abort, og 97 % (392/405) ville anbefalt behandlingstilbudet til andre i samme situasjon.
Fortolkning. Kvinnene i studien opplevde abortbehandling hos avtalespesialist som trygt. Tilbudet gir større valgfrihet til gravide som ønsker abort, og pasientene er tilfredse.
Background
Global estimates of unsafe abortions have been produced for 1995, 2003, and 2008. However, reconceptualisation of the framework and methods for estimating abortion safety is needed owing to the increased availability of simple methods for safe abortion (eg, medical abortion), the increasingly widespread use of misoprostol outside formal health systems in contexts where abortion is legally restricted, and the need to account for the multiple factors that affect abortion safety.
Methods
We used all available empirical data on abortion methods, providers, and settings, and factors affecting safety as covariates within a Bayesian hierarchical model to estimate the global, regional, and subregional distributions of abortion by safety categories. We used a three-tiered categorisation based on the WHO definition of unsafe abortion and WHO guidelines on safe abortion to categorise abortions as safe or unsafe and to further divide unsafe abortions into two categories of less safe and least safe.
Findings
Of the 55· 7 million abortions that occurred worldwide each year between 2010–14, we estimated that 30·6 million (54·9%, 90% uncertainty interval 49·9–59·4) were safe, 17·1 million (30·7%, 25·5–35·6) were less safe, and 8·0 million (14·4%, 11·5–18·1) were least safe. Thus, 25·1 million (45·1%, 40·6–50·1) abortions each year between 2010 and 2014 were unsafe, with 24·3 million (97%) of these in developing countries. The proportion of unsafe abortions was significantly higher in developing countries than developed countries (49·5% vs 12·5%). When grouped by the legal status of abortion, the proportion of unsafe abortions was significantly higher in countries with highly restrictive abortion laws than in those with less restrictive laws.
Interpretation
Increased efforts are needed, especially in developing countries, to ensure access to safe abortion. The paucity of empirical data is a limitation of these findings. Improved in-country data for health services and innovative research to address these gaps are needed to improve future estimates.
Funding
UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction; David and Lucille Packard Foundation; UK Government; Dutch Ministry of Foreign Affairs; Norwegian Agency for Development Cooperation.
Background
The minimum clinically important difference (MCID) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies. However, there is a lack of consensus about the size of MCID in acute pain, which is a core symptom affecting patients across many clinical conditions.
Methods
We identified and systematically reviewed empirical studies of MCID in acute pain. We searched PubMed, EMBASE and Cochrane Library, and included prospective studies determining MCID using a patient-reported anchor and a one-dimensional pain scale (e.g. 100 mm visual analogue scale). We summarised results and explored reasons for heterogeneity applying meta-regression, subgroup analyses and individual patient data meta-analyses.
Results
We included 37 studies (8479 patients). Thirty-five studies used a mean change approach, i.e. MCID was assessed as the mean difference in pain score among patients who reported a minimum degree of improvement, while seven studies used a threshold approach, i.e. MCID was assessed as the threshold in pain reduction associated with the best accuracy (sensitivity and specificity) for identifying improved patients. Meta-analyses found considerable heterogeneity between studies (absolute MCID: I² = 93%, relative MCID: I² = 75%) and results were therefore presented qualitatively, while analyses focused on exploring reasons for heterogeneity. The reported absolute MCID values ranged widely from 8 to 40 mm (standardised to a 100 mm scale) and the relative MCID values from 13% to 85%. From analyses of individual patient data (seven studies, 918 patients), we found baseline pain strongly associated with absolute, but not relative, MCID as patients with higher baseline pain needed larger pain reduction to perceive relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values.
Conclusions
The MCID in acute pain varied greatly between studies and was influenced by baseline pain, definitions of improved patients and study design. MCID is context-specific and potentially misguiding if determined, applied or interpreted inappropriately. Explicit and conscientious reflections on the choice of a reference value are required when using MCID to classify research results as clinically important or trivial.
p> Background: Intrauterine fetal death is means- intrapartum death after the fetus has reached the age of viability8. As in IUFD journey, labor pain will be fruitless. So, it is of utmost importance to search for the method which can reduce hours of pain in labor of IUFD cases.
Metarials Methods: In this research work patients divided in two groups. Induction of labour in one group was given by combination of mifepristone and misoprostol other group by misoprostol only and we try to find out the best method. To compare the effectiveness, induction to delivery interval, safety and side effects of combination of mifepristone and misoprostol versus conventional use of misoprostol alone in induction of labour in patients with intrauterine fetal death. It is a Prospective randomized comparative study in Anwer Khan Modern Medical College Hospital and Dhaka Medical College Hospital among 70 patients with IUFD after 28 weeks of gestation during January 2014- January 2016.
Result: We allowed the patients up to third gravid and after 28 weeks of gestation. Patients were grouped as Group A(35) & Group B (35). In Group A Induction was given by single oral dose of 200 mg mifepristone, and after 48 hours, tab. Misoprostol in post. fornix started if <34 weeks-100 μgm dose and >34 weeks-50 μgm dose. Doses were repeated every 6 hourly intervals if required. In Group B Induction was given by 100 μgm misoprostol at 6 hourly interval in post. Fornix. In both groups we allowed misoprostol maximum 600 μgm. Oxytocin was given for augmentation if needed. The two study groups did not differ demographically. Induction to delivery time was shorter with combined regimen group (P<0.001). Induction to delivery interval ranges from 10-12 hours in mifepristone plus misoprostole group.In only misoprostol group it was about 24-26 hours. Doses of misoprostol was lower in combined group (P<0.001). 4 patients need Oxytocin for augmentation in only misoprostol group. In combined group oxytocin was not needed. The two groups did not differ as regards complications experienced during labour and delivery significantly. In overall out come 2 failed induction in misoprostol only group but not in combinedgroup.
Conclusion: In Induction of IUFD mifepriston plus misoprostol is an effective combined group. It is safe, non invasive, easily tolerable, highly cost effective, had less induction to delivery interval, required less dose of misoprostol and no need of augmentation with oxytocin. So,the combined group is more effective than conventional regimen of misoprostol alone.
Anwer Khan Modern Medical College Journal Vol. 8, No. 1: Jan 2017, P 50-54</p
Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I ("Risk Of Bias In Non-randomised Studies-of Interventions"), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
Background:
Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting.
Methods/design:
We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days' gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women's physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion.
Discussion:
Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed.
Trial registration:
ACTRN12613000017729 (Prospectively registered 8/1/2013).
Objective:
The purpose of this study was to evaluate the success rate and complications of medical termination of pregnancy up to 49 days of amenorrhea and present the outcome of our phone questionaire of satisfaction of patients.
Design:
Retrospective analysis.
Setting:
Department of Obstetrics and Gynecology Masaryk University and University Hospital Brno.
Methods:
The analysis of 111 patients, who underwent medical termination of pregnancy at the Department of Obstetrics and Gynecology Masaryk University and University Hospital Brno from 1. 6. 2014 to 30. 6. 2015 using 600 mg of mifepristone (Mifegyne) and 400 µg of misoprostol (Mispregnol). In our set of patients we monitored subjective perception of medical termination of pregnancy (pain, nausea, vomiting, satisfaction with this method) and objective process (hospitalisation, surgical intervention). The view of patients was found out by the phone questionaireResults: Complete abortion without a surgical intervention underwent 103 patients. Nausea, pelvic pain, and intensity of bleeding were evaluated as suitable. Only 1 patient (0.9%) was hospitalised for nausea and 1 patient (0.9%) was hospitalised in case of need for an emergency curretage and transfusions. Some kind of contraception after the medical termination of pregnancy started using 98.0% of women. The satisfaction rate of this method was high - 101 patients declared themselves satisfied - 66.7% very satisfied, 24.3% rather satisfied.
Conclusion:
Medical termination of pregnancy has good efficiency, we consider it safe with minimum side-effects and is well evaluated by patients.
Objective
To evaluate the acceptability and efficacy of medical abortion at home up to 63 days gestation without limits on travel distance to a registered institution.DesignObservational prospective study.SettingHaukeland University Hospital between May 2006 and May 2009.Population1018 women requesting abortion before 63 days gestation who chose medical termination with mifepristone and home administration of misoprostol.Methods
The women took 200 mg mifepristone under nurse supervision and self-administered 800 micrograms misoprostol vaginally 36-48 hours later at home. All were contacted by phone for follow-up and assessment of bleeding, pain and acceptability.Main outcome measuresEvacuation rate, pain, bleeding, acceptability, influence of distance on treatment.ResultsMedian gestational age was 50 (range 35-63) days and 70 (7.1%) of the women lived more than 60 minutes travel from the clinic. The rate of completed abortion was 93.6% and surgical evacuation was performed in 50 (4.9%) cases. Two women requested treatment on the day of misoprostol use. Moderate to strong pain was experienced by 68.4%, and 74.7% reported moderate to heavy bleeding. Parous women experienced less pain than nulliparous women odds ratio 0.27 (95% CI 0.19-0.34). In all, 95.1% of the women were satisfied with staying at home. Travel distance did not influence treatment outcome variables.Conclusions
In our experience home administration of misoprostol is an effective and acceptable method for abortion up to 63 days of gestation and women can be eligible for this treatment option regardless of their travel distance from hospital.This article is protected by copyright. All rights reserved.
To study the efficacy of a low dose of mifepristone (100 mg) in combination with misoprostol, in women undergoing medical termination of pregnancy up to gestation of 49 days.
A prospective study was performed in 50 women (mean age 26.54±3.68 years) with single intrauterine pregnancy of up to 49 days of gestation, presenting to our institution between November 2007 and October 2009. 100 mg mifepristone was given orally, followed 24 hours later by 400 micrograms misoprostol vaginally. Misoprostol 400 micrograms was repeated vaginally on the third day if indicated. The primary outcome of complete abortion rate and secondary outcomes of induction-abortion interval and adverse effects, especially bleeding, were assessed.
Mean period of gestation was 38.74±3.90 days. None of the women expelled the products of conception before misoprostol insertion. A second dose of misoprostol was needed in four patients. Complete abortion was achieved in 94.00% of patients, incomplete abortion in 4% and missed abortion in 2%. Approximately all the women reported one or more adverse effects but none of them had any serious ones, the most common being pain in 42 (84%) women followed by nausea, vomiting, fever and diarrhoea in 12 (24%), 6 (12%), 4 (8%) and 3 (6%) women respectively. The overall acceptability rate of the dosing regimen in our study was 94%.
A regimen of low dose mifepristone (100 mg) followed 24 hours later by vaginal misoprostol can be safely and effectively used for early abortion.
Montrer l’efficacité et la bonne tolérance de l’association mifépristone 600 mg-misoprostol 800 μg dans l’IVG médicamenteuse de 9 à 14 semaines d’aménorrhée (SA).
Objective:
To explore the lowest effective dosage of mifepristone combined with misoprostol in terminating ultra-early pregnancy.
Methods:
All the cases of ultra-early pregnancy classified by amenorrhea days, β-hCG and vaginal B-ultrasonic were randomly divided into two groups. One hundred cases in G1 group (minimized dosage) were orally administered 25 mg mifepristone once a day for 2 days and combined with 200 µg misoprostol 48 hours later, while 150 mg mifepristone combined with 600 µg misoprostol 48 hours later were given to 100 cases in G2 group (normal dosage). All cases were observed for 6 hours after taking misoprostol and returned for assessment three days later.
Results:
None missing. Expulsion of conceptus: G1 and G2 group were 22 (22.0%, 22/100) and 25 (25.0%, 25/100; P > 0.05). Failure rate: cases with incomplete abortion were 1 (1.0%, 1/100) and 2 (2.0%, 2/100) in G1 and G2 group, hospitalization for suspected ectopic pregnancies both was 1 (1.0%). Bleeding: bleeding cases during the administration of mifepristone in G1 and G2 group were 71 (71.0%, 71/100) and 78 (78.0%, 78/100; P > 0.05); the mean bleeding time were (5.3 ± 1.4) days and (6.0 ± 1.5) days (P < 0.01). Other side effects: in G1 group, majority showed light nausea (7.0%, 7/100) and light abdominal pain (20.0%, 20/100). Menses recovery: 99 (99.0%, 99/100) for G1 group and 98 (98.0%, 98/100) for G2 group to recovery on scheduled time. Satisfactions: both were 99 (99.0%, 99/100). Except mean bleeding days and side-effects, the differences above showed no significance (P > 0.05).
Conclusion:
It is safe and effective treatment with the lowest dosages of mifepristone and misoprostol to terminate ultra-early pregnancies.
Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limitations of the original tool.
Objective:
To observe the effectiveness of electroacupuncture (EA) therapy in promoting medicinal abortion.
Methods:
Sixty participants with early pregnancy were randomly divided into medication (control) and EA+ medication groups (n=30 in each). Participants in the control group were treated by regular medication (mifepristone and misoprostol tablets), and those of the EA group were treated by EA stimulation (2 Hz/100 Hz, a tolerable strength) of bilateral Hegu(LI 4) and Sanyinjiao(SP 6) for 25 min, and also by the same medication method mentioned in the control group. Participants of both groups were admitted to the hospital for observation on the 3rd day after taking medication. The abdominal pain was assessed by visual analogue scale (VAS) score, and the foetal sac discharge duration and the complete abortion rate were recorded.
Results:
After the treatment, the VAS scores of both groups were significantly reduced in comparison with their own pre-treatment in each group (P<0.01), and the VAS score of the EA+ medication group was significantly lower than that of the medication group (P<0.01). The foetal sac discharge duration was significantly shorter in the EA+ medication group than in the medication group (P<0.01). The abortion rates showed no significant difference between the two groups (P>0.05).
Conclusion:
EA stimulation of Hegu(LI 4) and Sanyinjiao(SP 6) has a positive effect in assisting medicinal abortion in reducing abdominal pain and shortening foetal sac discharge duration.
Objective:
To evaluate whether prophylactic pregabalin reduces pain experienced with medication abortion.
Methods:
We conducted a randomized, double-blind, placebo-controlled trial of women initiating medication abortion with mifepristone and buccal misoprostol up to 70 days of gestation. Participants were randomized to 300 mg oral pregabalin or a placebo immediately before misoprostol. The primary outcome was maximum pain on an 11-point numerical rating scale, reported using real-time electronic surveys over 72 hours. Secondary outcomes included pain at each time point, ibuprofen and narcotic use, side effects, and satisfaction. We estimated that 110 women would be required to have 80% power to detect a difference in pain of 1.3 points.
Results:
Between June 2015 and October 2016, 241 women were screened and 110 were randomized (56 pregabalin, 54 placebo). Three were lost to follow-up. The primary outcome of mean maximum pain in the pregabalin group was 5.0±2.6 vs 5.5±2.2 in the placebo group (P=.32). Excluding medication taken before the study capsule, ibuprofen was used by 64% (35/55) of the pregabalin group vs 87% (45/52) placebo (P<.01). Narcotics were used by 29% (16/55) of the pregabalin group vs 50% (26/52) placebo (P<.03). More dizziness (P<.001), sleepiness (P<.04), and blurred vision (P<.05) occurred in the pregabalin group. Satisfaction scores for the analgesic regimen were higher in the pregabalin group (very satisfied: 47% vs 22%; P=.006).
Conclusion:
Compared with placebo, 300 mg pregabalin coadministered with misoprostol during medication abortion did not significantly decrease maximum pain scores. Women who received pregabalin were less likely to require any ibuprofen or narcotic and were more likely to report higher satisfaction with analgesia, despite an increase in dizziness, sleepiness, and blurred vision.
Clinical trial registration:
ClinicalTrials.gov, NCT02782169.
Objectives: The aims of the study were to describe the sociodemographic determinants, breastfeeding- and sexual life-related predictive factors of contraceptive use at 6–8 weeks postpartum.
Methods: A prospective, web-based questionnaire survey was carried out by distributing an access code to women immediately after delivery at the Department of Obstetrics and Gynaecology, University of Szeged, Szeged, Hungary, between 1 September 2013 and 1 May 2015.
Results: In total, 1875 women were invited to participate in the study, 632 of whom refused or were excluded and 644 were not sexually active. The remaining sexually active women (n=599) completed the questionnaire. At 6–8 weeks postpartum, 22.5% were using an effective contraceptive method and 40.2% were relying on lactational amenorrhoea (LAM). We found a significant direct association between the educational level of a woman’s partner and her use of an effective contraceptive method (p<0.001) adjusted odds ratio [AOR] 1.9) or LAM (AOR 1.49). Use of an effective contraceptive method before pregnancy increased the likelihood of using the same method after delivery (AOR 3.16) and decreased the likelihood of LAM use at weeks 6–8 (AOR 0.31). The AOR for effective contraceptive use was 2.23 times higher in women who had sexual intercourse once a week compared with those who had sexual intercourse less frequently.
Conclusion: Concerted efforts to promote the use of long-acting reversible contraception (LARC) are required, particularly among women who would like future childbearing. Further research is needed on the factors contributing to the low uptake of LARC in this population.
There are two methods of abortion: the medical and the surgical methods, each with its own specific benefits. Theoretically, the limit of medical abortion gestational age is 7 weeks of amenorrhea. However, since 2011, our university department provides the opportunity of a drug regimen until 9 weeks of amenorrhea. This paper describes the results of a retrospective study which covers 804 patients who were submitted to a medical abortion with gestational ages of 6 to 9 weeks. The purpose is to investigate the efficiency of the medical approach up to 9 weeks and to assess the drug dose required according to the term of pregnancy. Our work shows an efficiency of 95 % of medical abortion up to 9 weeks gestation, with no significant variation with the gestational age. However, maintaining this level of efficiency during the progress of pregnancy requires an increase of the administered doses of misoprostol. In addition, there is a significant increase in the use of analgesics. The medical abortion procedure remains effective until 9 weeks of gestation. This pharmacological approach reduces the risks induced, in the short and long term by the surgical procedure.
Objectives:
Although medical abortion with home use of misoprostol has been shown to be safe and acceptable, there are few data about the experience of pain during the procedure. The aims of this study were to assess the intensity of pain associated with home use of misoprostol for medical abortion and to identify variables associated with severe pain.
Methods:
This was an observational study using an anonymous web-based questionnaire in patients having a medical abortion at home in France between 1 December 2013 and 30 April 2014.
Results:
The questionnaire was completed by 232 women and the results of 193 were retained for analysis. The average pain score was 5.6 on a 10 point scale. A pain score ≥6 was rated as severe and was reported by 105 patients (54%). Nulliparity (odds ratio [OR] 4.10; 95% confidence interval [CI] 2.04, 8.22; p < .0001), lack of choice regarding the method of abortion (OR 2.32; 95% CI 1.13, 4.78; p = .0218) and lack of information about the level of pain associated with the procedure (OR 3.27; 95% CI 1.09, 9.74; p = .0334) were significantly correlated with severe pain. Analgesic prescriptions were very heterogeneous.
Conclusions:
Pain remains the main side effect of medical abortion. More studies are needed on pain assessment and the effectiveness of analgesic treatments in women using misoprostol at home for medical abortion, in order to improve their care and improve evidence-based guidelines.
Objective:
To compare outcomes with simultaneous administration of mifepristone and misoprostol with a regimen in which the drugs are administered at a 24-hour interval for second-trimester abortion.
Methods:
In this placebo-controlled, double-blind trial, participants were randomized to receive mifepristone either 24 hours before or at the same time as misoprostol. Participants were hospitalized to receive 400 micrograms buccal misoprostol at 3-hour intervals up to 48 hours or until uterine expulsion. The primary outcome was the proportion of women who experienced uterine expulsion within 24 hours after the first misoprostol dose and this required 504 women to examine our hypothesis that this rate would be 85% in the 24-hour interval arm compared with 70% in the simultaneous arm. Secondary outcomes included total abortion time from mifepristone and misoprostol.
Results:
From February 2013 to April 2014, 509 women were enrolled. Women in the 24-hour interval arm were more likely to abort within 24 hours (94.4% compared with 85.0%, relative risk 1.11, 95% confidence interval [CI] 1.05-1.18). At 48 hours, the rate was similar in the two arms (96.8% [24-hour interval] and 95.7% [simultaneous], relative risk 1.01, 95% CI 0.97-1.04). Median misoprostol dosing time was shorter in the 24-hour interval arm (7.7 compared with 13 hours; P<.001) and consistent with the median misoprostol doses required (three compared with five; P<.001). Median time from mifepristone to uterine expulsion was longer in the 24-hour interval arm (32.3 compared with 13 hours; P<.001). Both regimens had high acceptability rates and reported similar side effects and pain scores.
Conclusion:
Administering mifepristone and misoprostol simultaneously results in lower expulsion rates within 24 hours of taking misoprostol, longer median misoprostol treatment times, and requires more misoprostol doses. At 48 hours, both regimens work equally well. Simultaneous dosing results in less total time from the first clinical contact to complete abortion.
Clinical trial registration:
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01768299.
Objectives:
The aim of this study was to assess women's experiences of having an early medical abortion at home and to investigate their perceptions of the information provided before the abortion. The study also aimed to investigate possible differences between groups of women.
Study design:
The study is cross-sectional with a descriptive and comparative design. Semi-structured telephone interviews were conducted with 119 women who had undergone a medical abortion at home.
Results:
Almost half of the women (43%, n = 51) experienced the bleeding as more than expected and one-fourth (26%, n = 31) bled for more than four weeks. One-third (34%, n = 41) stated a lack of information, especially about the bleeding and pain. The experience of pain differed between groups. Women who had undergone an earlier abortion and women who had previously given birth experienced the abortion as being less painful than that experienced by first-time gravidae (p < 0.05).
Conclusions:
The finding that women experience information about the pain and bleeding to be insufficient suggests that information in those areas can be improved. The result that women without previous experience of abortion or childbirth stated the pain as being worse than other groups investigated suggests that special attention should be paid to those women.
Objectives To compare the efficacy of two different regimens of mifepristone followed by misoprostol for medical abortion in women with menstrual delay of ≤ 35 days.
Design Double‐blind, randomised controlled trial.
Setting Seventeen centres internationally.
Participants We enrolled 1589 healthy pregnant women with menstrual delay of ≤ 35 days who were requesting nonsurgical abortion.
Interventions Within gestational age strata, we randomly assigned women to receive a single oral dose of mifepristone, either 200 mg or 600 mg, followed in 48 h by misoprostol 400 μg by mouth. We concealed the allocation assignments from investigators and participants and maintained double‐blinding throughout the study.
Main outcome measures Complete abortion was the principal outcome measure. We also compared rates of side effects such as abdominal pain.
Results The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (89.3% vs 88.1%) The crude relative risk of failure to achieve complete abortion with the 200 mg dose compared with the 600 mg dose was 0.9 (95% CI 0.7 to 1.2). The likelihood of complete abortion was inversely related to gestational age, although this finding is exploratory in nature. Among failures the percentage of women with continuing pregnancies increased from 1.4% at menstrual delay of two weeks or less to 9.0% when the delay was 4–5 weeks. Low efficacy led to stopping enrolment at 29 to 35 days' menstrual delay. Stopping criteria were also met at completion of the study in the group with 22–28 days' menstrual delay. No significant differences emerged in the frequency of side effects between the two mifepristone groups.
Conclusions Both regimens had similar efficacy. Women with a menstrual delay of four to five weeks had twice the risk of failure to abort compared with those who received treatment within two weeks of the expected menses. The efficacy of the mifepristone‐prostaglandin regimen was not reduced by decreasing the dose of mifepristone from 600 mg to 200 mg. The regimens of 600 mg or 200 mg of mifepristone, followed by a single oral dose of misoprostol 400 μg 48 hours later, were not sufficiently efficient in inducing abortion when the menstrual delay was > 21 days.
A multicentre, randomized, comparative clinical trial of 200 mg RU486 (Mifepristone) followed 48 h later by either 5 mg 9-methylene PGE2 vaginal gel (meteneprost) or 600 μg oral PGE1 (misoprostol) for termination of pregnancy within 28 days of the missed period, was carried out through the Indian Council of Medical Research's (ICMR) network of Human Reproduction Research Centres (HRRCs). A total of 893 subjects were assessed regarding their therapeutic responses to the two different treatment groups. The results indicated a success rate of 84.6% among 453 women treated with RU486 followed by 9 methylene PGE2 vaginal gel, that was not significantly different from the success rate of 87.7% observed in 440 women treated with RU486 followed by oral PGE1. The majority of study subjects (90%) started bleeding within 72 h. About 26% of the subjects had started bleeding before the administration of any prostaglandin. The average duration of bleeding in all the subjects was about 7 days. No life threatening side effects were observed among the subjects in two treatment groups. Gastro-intestinal complaints were reported more often by women treated with oral PGE1 as compared to those treated with 9-methylene vaginal PGE2 gel; nausea occurred in 25.7% and 19.2%, vomiting in 6.8% and 4.6%, and diarrhoea in 4.8% and 0.9% of the subjects in the 2 treatment groups, respectively. Fever higher than 38°C and severe abdominal pain were reported by 4.2% and 5.0% of all subjects treated, respectively. Intravenous infusion of glucose and saline was required by 6 subjects in each treatment of the prostaglandin treated groups. Blood transfusion was required in 2 subjects, one in each treatment group, for profuse bleeding.
To compare efficacy between medical and surgical abortion at 9 weeks of gestation or less.
We performed a retrospective cohort study comparing efficacy of medical compared with surgical abortion before 64 days of gestation at Planned Parenthood, Los Angeles, from November 2010 to August 2013. Electronic medical records were reviewed for ongoing pregnancies after the initial abortion procedure. Data were also collected on complications occurring within the immediate postabortal period (8 weeks postabortal) including unanticipated aspiration and major adverse events (emergency department presentation, hospitalization, perforation, transfusion, infection). Chi square test and logistic regression were used to compare the primary outcomes between cohorts.
Data were collected from 30,146 women with pregnancies seeking termination before 64 days of gestation. Sociodemographic and clinical characteristics were similar in the medication and surgical abortion groups. Efficacy of pregnancy termination was 99.6% for medication abortions and 99.8%% for surgical abortions (P<.001). The medication abortion group was more likely to undergo an unanticipated aspiration, for ongoing pregnancy or persistent pain, bleeding, or both (2.1% compared with 0.6%, respectively, odds ratio 1.6, 95% confidence interval 1.1-2.3). These rates were unchanged after controlling for gravidity, parity, and body mass index. There was no difference in major adverse events between the two groups.
Medication abortion and surgical abortion before 64 days of gestation are both highly effective with low complication rates.
II.
Objectives
Home use of misoprostol for medical abortion is more convenient for many women than in-clinic use, but requires management of abortion symptoms at home without provider back-up. This study evaluated whether automated text messages to women undergoing medical abortion can reduce anxiety and emotional discomfort, and whether the messages can better prepare women for symptoms they experience.
Study design
A multisite randomized controlled trial was conducted in which women undergoing early medical abortion were allocated to receive standard-of-care (SOC) only (n = 235), or SOC + a messaging intervention (n = 234). Consenting women were interviewed at the clinic after taking mifepristone and again at their follow-up clinic visit 2 – 3 weeks later; the intervention group received text messages over the duration of this period. Emotional outcomes were evaluated using the Hospital Anxiety and Depression Scale, Adler’s 12-item emotional scale and the Impact of Event Scale-Revised. Preparedness for the abortion symptoms and overall satisfaction with the procedure were assessed using 4-point Likert-type scales.
Results
Between baseline and follow-up, anxiety decreased more (p = 0.013), and less emotional stress was experienced (adjusted for baseline anxiety, p = 0.015), in the intervention compared to the SOC group. Participants in the intervention group were also more likely to report that they felt very well prepared for the bleeding (p < 0.001), pain (p = 0.042) and side effects (p = 0.027) they experienced. Acceptability and other negative emotions relating to the abortion did not differ between study groups. Ninety-nine percent of the intervention group stated that they would recommend the messages to a friend having the same procedure.
Conclusions
Text messages to women following mifepristone administration for early medical abortion may assist them in managing symptoms and appear highly acceptable to recipients.
Implication Statement
This randomized controlled trial provides evidence for the effectiveness of text messages following mifepristone administration in strengthening medical abortion care. The messages were associated with significant reductions in women’s anxiety and stress during the abortion process, they improved preparedness for the abortion symptoms experienced, and appeared highly acceptable.
To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion.
We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimens: therapeutic (800 mg every 4-6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4-6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0-10 daily thereafter.
Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar.
We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521. LEVEL OF EVIDENCE:: I.
Background and aims
Medical abortion is often performed at outpatient clinics or gynaecological wards. Yet, some women may stay at home during medical abortion. Pain has been reported to be one of the main side effects of the procedure.
Methods
We studied whether perceived abortion pain was related to the subjectively evaluated ability to stay at home during medical abortion. The size of the study group was 29 women. We also studied how well these women remembered the intensity and unpleasantness of the abortion pain in a control visit performed 3–6 weeks after abortion.
Results
Especially, the unpleasantness associated with the pain during abortion was an important predictor when women evaluated their ability to stay at home during medical abortion. In those women who might have been able to stay at home in their own view, midwives looking after these women at the outpatient clinic estimated the pain intensity and unpleasantness also about 50% lower than in those who were not able to stay home in their own view. There were no significant differences in intensity, unpleasantness in hindsight of menstruation pain, or the area of this pain in the pain drawings in those women who considered that they might have stayed at home during medical abortion when compared with those who did not. No difference was found in age, gestational age, magnitude of previous pregnancies, miscarriages, vaginal deliveries, induced abortions, Beck’s Depression Index (BDI), Beck’s Anxiety Index (BAI) or AUDIT scores between those who could have stayed at home or those who would not have been able to stay at home during abortion. Components of abortion pain decreased significantly during the second post-abortion day. The more deliveries the subject had experienced the less pain she had during abortion. Multiparous women reported less than a fourth of the pain magnitude of the nulliparous women during abortion. Parity explained both intensity and unpleasantness of abortion pain better than the expected ability to stay at home. The remembrance of the intensity or unpleasantness of abortion pain correlated with actual pain reported at the time of abortion. However, this remembrance did not correlate with the ability to stay at home during the medical abortion.
Conclusions
The unpleasantness of pain during and immediately after abortion was recalled, not as a measure of the pain itself, but as a deciding factor in their judgement of whether or not they would be able to undergo medical abortion at home. Abortion pain is an important factor in enhancing home-based management of medical abortions. Medical staff may be able to detect those women who do not cope at home during the process by observing the intensity of pain. Therefore, proper treatment of pain might reduce the need for hospital-based medical abortions.
Implications
These patients need better care and guidelines for the care of women undergoing medical abortions should include clear recommendations for analgesic treatments, at the least adequate doses of nonopioid analgesics such as paracetamol in combination with NSAIDs like ibuprofen or diclofenac.
Background: Studies have demonstrated that acupuncture can assist in the completion rate of abortion, also reducing bleeding time, abdominal pain, and return of menses. Objectives: To assess the effects of electroacupuncture (EA) with different stimulation parameters on assisting medicine-induced abortion, and to determine the best combination of stimulation parameters of EA to optimize the clinical therapeutic effects of medicine-induced abortion. Design, Setting, and Patients: A controlled trial of 109 pregnant women (<2 months' gestation) who requested medicine-induced abortion at the outpatient clinic of the gynecology department of Dong Zhi Men Hospital in Beijing, China, from March through July 2004. Women were allocated to 2 different EA treatment groups or a medicine-only control group. Intervention: Thirty to 60 minutes after oral administration of misoprostol, EA was applied to both treatment groups. In treatment group A, LI 4 and SP 6 were piquered bilaterally and stimulated with 100 Hz cluster waves at the highest intensity each woman could tolerate. In treatment group B, initially, LI 4 was piquered for 20 minutes, then SP 6 was piquered 5 minutes later and stimulated with 50-Hz continuous waves at the highest intensity each woman could tolerate. EA was not applied in the control group. Main Outcome Measures: Abortion rate, time to eliminate the embryonic sac, degree of abdominal pain, and colporrhagia duration were recorded. Results: Completed abortion rates in the treatment groups were higher than that in the control group, but the difference was not significant (range, 82%-92%). Significant differences were reported in abdominal pain between treatment group B and the control group (P < .01), and the EA protocol of treatment group B also relieved pain significantly better than the treatment protocol for group A (P < .05). The duration of eliminating the embryonic sac in groups B and A were significantly shorter than in the control group (P < .01, P < .05, respectively). Colporrhagia duration in the 2 treatment groups was significantly shorter than in the control group (P < .01). No serious adverse events were reported. Conclusions: Different EA stimulation parameters have different effects on abortion. The stimulation parameters of EA applied in treatment group B (EA with 50-Hz continuous waves, first at LI 4 for 20 minutes, then 5 minutes later, adding SP 6) were more effective in relieving the abdominal pain, shortening the time to eliminate the embryonic sac, and colporrhagia duration in women undergoing medicine-induced abortion.
Because of the highly stigmatized nature of abortion care delivery and the restriction of abortion provision in most states, little is known about abortion care quality beyond procedural safety. This study examined which aspects of abortion care contributed to patient experiences. Data from a prospective, observational study of 9087 women aged 16 to 44 years, from 22 clinics across California, who responded to a postprocedure survey, were analyzed using mixed-effects logistic regression. Patient experience scores were very high (mean overall satisfaction = 9.4 [0-10 scale]) for all clinicians trained in abortion provision (physicians, nurse practitioners, nurse-midwives, and physician assistants). Multiple patient factors (pain rating, expectations of care, sociodemographics) and clinic-level factors (timely care, treatment by clinicians and staff) were significantly associated with patient experience. Study findings demonstrated that clinic environment, treatment by clinical staff, and managed pain levels contributed to a patient's experience of abortion care, whereas clinician type was not significantly associated.
To describe the use of mifepristone in combination with buccal misoprostol in women undergoing an early medical abortion (EMA) in Australia.
Retrospective, observational study of 13,345 EMAs (gestational age ≤ 63 days) conducted at 15 Marie Stopes International Australia clinics between 1 September 2009 and 31 August 2011.
Oral mifepristone 200 mg, administered at the clinic, followed 24-48 hours later by buccal misoprostol 800 µg, self-administered at home.
Failure rate (proportion of women with an incomplete abortion requiring surgical aspiration or a continuing pregnancy).
Pregnancy termination follow-up information was available for 83.4% (11 155/13 376) of EMAs. From the patient demographic database, the EMA failure rate was 3.5% (465/13 345). Of these, most (382; 2.9% of total) were incomplete abortions requiring surgical aspiration, and 83 (0.6% of total) were continuing pregnancies. Haemorrhage (16; 0.1%) and known or suspected infection (25; 0.2%) were infrequent. One woman, who did not seek follow-up despite signs of infection, died from sepsis (< 0.01%). In 6755 EMAs with clinic follow-up from April 2010 to August 2011, 6381 women participated in a survey. Most reported medium or heavy bleeding and moderate or severe pain/cramps; most also reported that bleeding, pain/cramps and their overall experience were as expected or better than expected.
Mifepristone, with buccal misoprostol self-administered at home, for EMA up to 63 days of gestation had a low failure rate, was well accepted, and provided an effective treatment option with a favourable safety profile for women seeking an abortion in Australia.
To assess the efficacy of medical abortion and patient satisfaction in the clinic setting, in addition to determining healthcare providers' views.
From 2006 to 2008, 2400 women were enrolled at 10 Vietnam Family Planning Association (VINAFPA) clinics in an operations research project. Participants took 200mg of oral mifepristone in the clinic and 400μg of oral misoprostol 2days later at home or in the clinic. Abortion status was assessed at follow-up. Furthermore, in 2006, 900 clinicians at 45 health facilities answered a knowledge, attitudes, and practices survey to capture providers' views.
In total, 93.8% of participants had successful medical abortions. The majority (84.5%) administered misoprostol at home. Adverse effects included bleeding, pain/cramps, and nausea. Most women (92.6%) were satisfied/very satisfied with the method. Most providers who took the survey (85.6%) recommended that medical abortion be introduced at VINAFPA clinics.
The operations research data demonstrate the safety, efficacy, and acceptability of medical abortion at VINAFPA clinics. The majority of surveyed providers endorsed adding medical abortion at their own facilities. Developing national guidelines for providing medical abortion at the clinic level is an important step in expanding access to services in Vietnam.
Objective To investigate the clinical efficacy of the combination of mifepristone and an orally active prostaglandin, misoprostol, for early medical termination.
Design Women with amenorrhoea ≤56 days were given 200 mg mifepristone. 48 h later, 600 μg misoprostol was given orally.
Setting Medical Termination Unit, Simpson Memorial Maternity Pavilion, Edinburgh.
Subjects 100 women requesting medical termination of pregnancy.
Interventions Evacuation of uterus for incomplete abortion or on-going pregnancies.
Results One woman had an incomplete abortion prior to administration of misoprostol. 92 (93%) out of 99 women had complete abortion following administration of misoprostol. There were three on-going pregnancies (3.0%, 95% confidence limits (CL) 0.6-8.6) and four incomplete abortions with this regimen (4.0%, 95% CL 1.1-10.0). 24% women vomited and 7% had diarrrhoea following administration of misoprostol. 62% did not require any analgesia.
Conclusions The combination of misoprostol with mifepristone is inexpensive, simple, effective, noninvasive and an acceptable alternative to current regimens for medical termination.
Objective. The purpose of the study was to investigate anxiety and other factors that may predict pain magnitude following termination of pregnancy (TOP) during the first trimester.
Design. Prospective, nonrandomized study.
Setting. Department of Obstetrics and Gynecology, Rambam Medical Center in Haifa, Israel.
Patients. Forty consecutive women undergoing TOP.
Outcome Measures. Women undergoing a TOP were asked to fill out the State–Trait Anxiety Inventory. Pain magnitude was measured by using a visual analog scale (VAS) at 15, 30, and 60 minutes following the procedure. Correlations between state anxiety, trait anxiety, age, parity, number of TOP, gestational age, and pain magnitude were measured.
Results. State anxiety was able to predict pain magnitude on VAS 15 minutes after TOP (P = 0.023), and trait anxiety was able to predict pain magnitude on VAS 30 minutes after TOP (P = 0.013). Other variables failed to show significant results.
Conclusions. Preoperative assessment of anxiety levels may lead to appropriate treatment in order to alleviate discomfort and ensure pain control outcome.
Previous studies of medical abortion with mifepristone and a prostaglandin have reported percentages of subjects who experience cramping and/or bleeding relative to prostaglandin use. This is the first analysis of cramping and bleeding onset patterns in subjects treated with low-dose (200 mg) mifepristone and 800 μg vaginal misoprostol at 24, 48, or 72 h after mifepristone. We analyzed the cramping and bleeding onset patterns in subjects up to 8 weeks pregnant who used 800 μg vaginal misoprostol at 24, 48, or 72 h after 200 mg of oral mifepristone. We collected data from subjects’ symptom diaries and divided symptom onset into 3 categories: before misoprostol use, 0–12 h following misoprostol, and more than 12 h after misoprostol. Of the 2,302 subjects, cramping and bleeding onset data were available for 2,030 (88%) and 2,123 (92%), respectively. Across all groups, 230 (11%) experienced cramping and 445 (21%) experienced bleeding before misoprostol use. There was a significantly higher percentage of subjects who experienced early cramping and/or early bleeding between the three treatment groups, and this was related to the interval between mifepristone and misoprostol. In the 12 h following misoprostol administration, cramping and bleeding patterns were similar in the three groups. The longer subjects waited to insert misoprostol, the more likely they were to experience early cramping and/or bleeding. After misoprostol insertion, cramping and bleeding patterns are similar regardless of treatment group. Patients and providers cannot rely on symptom onset to predict treatment success.
To determine the efficacy of pre-emptive administration of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen vs. a placebo on pain relief during medical abortion and to evaluate whether NSAIDs interfere with the action of misoprostol.
Prospective, double-blind, randomized, controlled study.
University-affiliated tertiary hospital.
Sixty-one women who underwent first-trimester termination of pregnancy.
Patients received 600 mg mifepristone orally, followed by 400 μg oral misoprostol 2 days later. They were randomized to receive pre-emptively two tablets of 400 mg ibuprofen orally or a placebo, when taking the misoprostol. The patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after the medical abortion.
Significant pain, assessed by the need for additional analgesia, and failure rates, defined by a need for surgical intervention.
Pre-emptive ibuprofen treatment was found to be more effective than a placebo in pain prevention, as determined by a significantly lower need for additional analgesia: 11 of 29 (38%) vs. 25 of 32 (78%), respectively. Treatment failure rate was not statistically different between the ibuprofen and placebo groups: 4 of 28 (14.2%) vs. 3 of 31 (9.7%), respectively. History of menstrual pain was predictive for the need of additional analgesia.
Pre-emptive use of ibuprofen had a statistically significant beneficial effect on the need for pain relief during a mifepristone and misoprostol regimen for medical abortion. Ibuprofen did not adversely affect the outcome of medical abortion.
NCT00997074.
Surgical abortion by vacuum aspiration or dilatation and curettage has been the method of choice for early pregnancy termination since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins.
To compare different medical methods for first trimester abortion.
The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted.
Types of studies Randomised controlled trials comparing different medical methods for abortion during first trimester (e.g. single drug, combination) were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant during the first trimester, undergoing medical abortion were the participants. The outcomes were mortality, failure to achieve complete abortion, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the procedure.
Two reviewers independently selected trials for inclusion from the results of the search strategy described previously.The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. Data were processed using Revman software.
Fifty-eight trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. Sublingual and buccal routes were similarly effective compared to the vaginal route, but had higher rates of side effects. 2) Mifepristone alone is less effective when compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Five trials compared prostaglandin alone to the combined regimen (mifepristone/prostaglandin). All but one reported higher effectiveness with the combined regimen. The results of these studies could not be combined but the RR of failure with prostaglandin alone is reportedly between 1.4 to 3.75 with the 95% confidence intervals indicating statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference in effectiveness with use of a divided dose compared to a single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin demonstrates similar rates of failure to complete abortion when comparing intramuscular to oral methotrexate administration (RR 2.04, 95% CI 0.51 to 8.07). Similarly, day 3 vs. day 5 administration of prostaglandin following methotrexate administration showed no significant differences (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs. methotrexate and no statistically significant differences were observed in effectiveness between the groups.
Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Vaginal misoprostol is more effective than oral administration, and has less side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all trials were conducted in settings with good access to emergency services, which may limit the generalizability of these results.
Knowledge on factors affecting acceptability of medical abortion with mifepristone followed by home administration of misoprostol is scarce. The objective of this study was therefore to assess factors affecting acceptability and experience of home use of misoprostol for medical abortion up to 63 days' gestation.
Prospective observational study with acceptability assessed through questionnaires. Factors affecting acceptability were analyzed using multivariate logistic regression.
A total of 395 women were included. Independent factors for acceptability were having a partner/friend present and having a positive low-sensitivity urine hCG at follow-up, although most of these patients had successful abortions. Age, gestational length and requirement of extra pain medication did not affect acceptability.
Home administration of misoprostol is highly acceptable. Increasing the number of complete abortions should be a focus of future research. Women should be encouraged to have a partner/friend present during home administration of misoprostol.
Although induced abortion is one of the most commonly performed gynecological procedures in Great Britain and medical termination of pregnancy is being used more frequently, very little is known about the role of ambulation during the procedure. We sought to compare ambulatory and non-ambulatory groups of patients undergoing medical termination in the hospital setting and determine whether ambulation impacted clinical outcomes.
This was a prospective patient-preference study carried out among 130 women with pregnancies up to 63 days of gestation fulfilling the requirements of the 1967 Abortion Act and undergoing medical termination of pregnancy. The objective was to evaluate the effect of ambulation during medical termination of pregnancy. The women were given the choice to be ambulatory or non-ambulatory throughout the process of medical termination of pregnancy. They received 200 mg oral mifepristone and 800 mcg vaginal misoprostol for the termination procedure. Outcomes measured included time taken to pass the products of conception, first feeling of abdominal cramps, estimated blood loss, time to discharge from the hospital, pain scores and need for analgesia.
In both ambulatory and non-ambulatory groups, the mean time taken to pass the products of conception was similar: 230.7 min (118-343.4) and 233.0 min (134.5-331.5) for ambulatory and non-ambulatory patients, respectively. Time to onset of cramps was 75.6 min (29.4-121.8) for ambulatory and 91.7 min (22.2-161.2) for non-ambulatory patients, from administration of misoprostol. Mean estimated blood loss (assessed by weighing the pads as well as blood in bed pan) was less than 100 mL in both groups, and overall, approximately 85% of patients ranked their pain score as 3 or less (on a scale of 0-5). There were no statistically significant differences in the ambulatory versus non-ambulatory groups with regard to clinical outcomes.
Ambulation during medical termination of pregnancy neither appears to influence the amount of bleeding or pain nor hasten the process of medical termination of pregnancy.