Recommendations for scale-up of community-based misoprostol distribution programs

Community-based distribution of misoprostol for prevention of postpartum hemorrhage (PPH) in resource-poor settings has been shown to be safe and effective. However, global recommendations for prenatal distribution and monitoring within a community setting are not yet available. In order to successfully translate misoprostol and PPH research into policy and practice, several critical points must be considered. A focus on engaging the community, emphasizing the safe nature of community-based misoprostol distribution, supply chain management, effective distribution, coverage, and monitoring plans are essential elements to community-based misoprostol program introduction, expansion, or scale-up.     

米索前列醇用于预防产后出血的临床探讨

目的　探讨口服米索前列醇预防产后出血的价值。方法　采用回顾性资料分析方法 ,对我院2 0 0 1年 1月～ 2 0 0 2年 12月收住院的正常单胎头位足月妊娠经阴道试产者 16 0 0例随机分为两组。研究组 80 0例 ,在第二产程胎头娩出后即口服米索前列醇 6 0 0 μg ;对照组 80 0例 ,在胎头娩出后静脉予催产素 2 0U。观察产后2h出血量 ,产后出血发生率 ,新生儿窒息发生率及用药前后血压变化。结果　产后 2h出血量 ,研究组与对照组分别为 16 8 4 5± 6 0 5 6ml和 188 75± 95 32ml,两组比较差异有统计学意义 (P <0 0 1)。产后出血发生率 ,研究组与对照组分别为 1 2 5 %和 3 75 % ,两组比较差异有统计学意义 (P <0 0 1)。新生儿窒息发生率及用药前后血压变化对比差异无统计学意义 (P >0 0 5 )。结论　口服米索前列醇预防产后出血优于催产素 ,不仅能减少产后出血量 ,降低产后出血发生率 ,且给药方法简便、安全 ,便于推广应用。     

米索前列醇预防剖宫产术后出血的临床研究

目的观察米索前列醇用于剖宫产预防产后出血的效果。方法选择１８２例剖宫产者,随机分为米索前列醇组、米索前列醇＋催产素组及催产素组。米索前列醇组６０例,术中打开腹膜时口服米索前列醇６００μｇ。米索前列醇＋催产素组６４例,术中打开腹膜时口服米索前列醇６００μｇ,胎儿娩出后宫体肌内注射催产素２０ＩＵ。催产素组５８例,胎儿娩出后宫体肌内注射催产素２０ＩＵ,再静脉滴注催产素２０ＵＩ。以上各组观察术中及术后２小时内出血量。结果术中及术后２小时平均出血量,米索前列醇组为２１２±５６０ｍｌ;米索前列醇＋催产素组为２０８±５５４ｍｌ;催产素组为３４５±６４７ｍｌ。米索前列醇组与催产素组比较,差异有极显著性（Ｐ＜００１）。米索前列醇组与米索前列醇＋催产素组比较,差异无显著性（Ｐ＞００５）。结论米索前列醇促进子宫收缩作用强于催产素,能较好地预防剖宫产术后出血,且用药方便、安全。     

Facilitating women’s access to misoprostol through community-based advocacy in Kenya and Tanzania

Objective

To explore the feasibility of educating communities about gynecologic uses for misoprostol at the community level through community-based organizations in countries with restrictive abortion laws.

Methods

In 2012, the Public Health Institute and Ipas conducted an operations research study, providing small grants to 28 community-based organizations in Kenya and Tanzania to disseminate information on the correct use of misoprostol for both abortion and postpartum hemorrhage. These groups were connected to pharmacies selling misoprostol. The primary outcomes of the intervention were reports from the community-based organizations regarding the health education strategies that they had developed and implemented to educate their communities.

Results

The groups developed numerous creative strategies to reach diverse audiences and ensure access to misoprostol pills. Given the restrictive environment, the groups attributed their success to having addressed the use of misoprostol for both indications (abortion and postpartum hemorrhage) and to using a harm reduction approach to frame the advocacy.

Conclusion

This initiative proves that, even where abortion is legally restricted and socially stigmatized, community-based organizations can publicly and openly share information about misoprostol and refer it to women by using innovative and effective strategies, without political backlash. Furthermore, it shows that communities are eager for this information.     

Oral misoprostol in the third stage of labor.

OBJECTIVE: To compare the efficacy of intravenous ergometrine, intramuscular oxytocin, and oral misoprostol in the control of postpartum hemorrhage. METHODS: Mean blood loss, rates of blood loss between 500 and 1000 ml, hematocrit fall greater than 10%, and need for additional oxytocic agents and nature and rates of adverse effects were assessed in this prospective, randomized, controlled study. RESULTS: All outcomes were similar in the 3 groups. The main adverse effects in the misoprostol group were temperatures higher than 99 degrees F, which normalized within 2 h and shivering, which was mild and self-limiting. CONCLUSIONS: Oral misoprostol is as effective as conventional oxytocic agents in preventing postpartum hemorrhage and can be recommended for use in low-resource settings.     

Community-based distribution of misoprostol for treatment or prevention of postpartum hemorrhage: Cost-effectiveness, mortality, and morbidity reduction analysis

Objective

To compare the cost-effectiveness of community-based distribution of misoprostol for prevention with misoprostol for treatment of postpartum hemorrhage (PPH).

Methods

A Monte Carlo simulation depicted mortality and anemia-related morbidity attributable to PPH among 3 scenarios of 10 000 women delivering at home in rural India: (1) standard management; (2) standard management plus 800 µg of sublingual misoprostol for PPH treatment; and (3) standard management plus 600 µg of prophylactic oral misoprostol. The model included costs of drugs, birth attendant training, and transport for women who did not respond to misoprostol.

Results

Misoprostol lowered mortality by 70% and 81% in scenarios 2 and 3, respectively. Scenarios 2 and 3 raise costs by 6% and 35%, respectively. Incremental cost per disability-adjusted life year (DALY) saved is estimated at $6 and $170, respectively.

Conclusion

Both interventions were more effective at decreasing mortality and anemia than standard management. The most efficient scale-up plan would focus initially on increasing coverage with the treatment strategy ($6 per DALY).     

Introduction of misoprostol for prevention of postpartum hemorrhage at the community level in Senegal

Objective

To demonstrate that training ensures correct administration of oral misoprostol by auxiliary midwives for prevention of postpartum hemorrhage (PPH) among women giving birth at the community level in Senegal.

Methods

A 6-day training program for auxiliary midwives and supervisors, including 1 day of PPH prevention training and a practicum of 10 deliveries at health centers and 3 deliveries at maternity huts, was conducted in 2 Senegalese districts in June–July 2009. Data were collected between July and December 2009 on the administration of oral misoprostol by trained auxiliary midwives among 245 women giving birth at health centers, health posts, and maternity huts.

Results

All participating women received the correct administration of oral misoprostol; however, few women delivering in the community-based maternity huts received the supervision that is locally required to administer misoprostol. Women were willing to pay for some or all of the costs of misoprostol for PPH prevention.

Conclusion

Timely management of PPH is essential to reduce maternal mortality. With limited training, auxiliary midwives achieved the correct administration of oral misoprostol that can attain this goal. Community delivery supervised by a skilled attendant limits access to, and need not be a requirement for, PPH prevention.     

Prevention of postpartum hemorrhage at home birth in Afghanistan

Objective

To test the safety, acceptability, feasibility, and effectiveness of community-based education and distribution of misoprostol for prevention of postpartum hemorrhage at home birth in Afghanistan.

Methods

A nonrandomized experimental control design in rural Afghanistan.

Results

A total of 3187 women participated: 2039 in the intervention group and 1148 in the control group. Of the 1421 women in the intervention group who took misoprostol, 100% correctly took it after birth, including 20 women with twin pregnancies. Adverse effect rates were unexpectedly lower in the intervention group than in the comparison group. Among women in the intervention group, 92% said they would use misoprostol in their next pregnancy. In the intervention area where community-based distribution of misoprostol was introduced, near-universal uterotonic coverage (92%) was achieved compared with 25% coverage in the control areas.

Conclusion

In Afghanistan, community-based education and distribution of misoprostol is safe, acceptable, feasible, and effective. This strategy should be considered for other countries where access to skilled attendance is limited.     

Oral misoprostol for prevention of postpartum hemorrhage by paramedical workers in India.

OBJECTIVE: To study whether paramedical workers from rural primary health centers in India are able to administer oral misoprostol and actively manage the third stage of labor to prevent postpartum hemorrhage (PPH). METHOD: Cluster randomization was used to enroll 1200 women at 30 peripheral health centers from 5 states in India, 600 forming the study's intervention group (active management of the third stage of labor with 600 mug of oral misoprostol) and 600 forming the comparison group (in which the current government guidelines for the prevention of PPH were followed). The primary outcome was blood loss after delivery, which was measured using a calibrated blood collection drape. RESULTS: Age, literacy level, occupation, and gravidity were similar in the 2 groups. More than 70% of women in both groups had moderate anemia (hemoglobin level <10 g/dL). Paramedical workers followed instructions in almost all deliveries in the intervention group (99%). There was a significant reduction in duration of the third stage of labor (7.9 +/- 4.2 min vs. 10.9 +/- 4.3 min; p < .001) and median blood loss after delivery (100 mL vs. 200 mL; p < .001) in the intervention group. Overall, a low incidence of PPH was observed (<1%) in both groups. A greater number of women had moderate to severe shivering (12.7% vs. 0.5%) and a temperature higher than 38 degrees C (9.7% vs. 4.3%) in the intervention group, which was statistically significant. CONCLUSION: Simple interventions can be easily implemented in rural health care settings to reduce the blood loss during labor. This finding has significant implications for developing countries, in which the prevalence of anemia is high.     

Advance distribution of misoprostol for the prevention of postpartum hemorrhage in South Sudan

Objective

To determine if high uterotonic coverage can be achieved in South Sudan through a facility- and community-focused postpartum hemorrhage (PPH) prevention program.

Methods

The program was implemented from October 2012 to March 2013. At health facilities, active management of the third stage of labor (AMTSL) was emphasized. During prenatal care and home visits, misoprostol was distributed to pregnant women at approximately 32 weeks of pregnancy for the prevention of PPH at home births. Data on uterotonic coverage and other program outcomes were collected through facility registers, home visits, and postpartum interviews.

Results

In total, 533 home births and 394 facility-based births were reported. Misoprostol was distributed in advance to 787 (84.9%) pregnant women, of whom 652 (82.8%) received the drug during home visits. Among the women who delivered at home, 527 (98.9%) reported taking misoprostol. A uterotonic for PPH prevention was provided at 342 (86.8%) facility-based deliveries. Total uterotonic coverage was 93.7%. No adverse events were reported.

Conclusion

It is feasible to achieve high coverage of uterotonic use in a low-resource and postconflict setting with few skilled birth attendants through a combination of advance misoprostol distribution and AMTSL at facilities. Advance distribution through home visits was key to achieving high coverage of misoprostol use.     

Side effects of oral misoprostol for the prevention of postpartum hemorrhage: Results of a community-based randomised controlled trial in rural India

Objective. To investigate the side effects of 600 μg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH).

Methods. One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe.

Results. Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns.

Conclusions. Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.     

A randomized controlled trial on the value of misoprostol for the treatment of retained placenta in a low-resource setting

Objective

To evaluate the efficacy and safety of misoprostol among patients with retained placenta in a low-resource setting.

Methods

A prospective, multicenter, randomized, double-blind, placebo-controlled trial was carried out in Tanzania between April 2008 and November 2011. It included patients who delivered at a gestational age of 28 weeks or more and had blood loss of 750 mL or less at 30 minutes after delivery. Sublingual misoprostol (800 μg) was compared with placebo as the primary treatment. Power analysis showed that 117 patients would be required to observe a reduction of 40% in the incidence of manual removal of the placenta (MRP; P = 0.05, 80% power), the primary outcome. The secondary outcomes were blood loss and number of blood transfusions.

Results

Interim analysis after recruitment of 95 patients showed that incidence of MRP, total blood loss, and incidence of blood transfusions were similar in the misoprostol (MRP, 40%; blood loss, 803 mL; blood transfusion, 15%) and placebo (MRP, 33%, blood loss 787 mL, blood transfusion, 23%) groups. The trial was stopped because continuation would not alter the interim conclusion that misoprostol was ineffective.

Conclusion

Treatment with misoprostol was found to have no clinically significant beneficial effect among women with retained placenta.Clinical Trial Registration: Current Controlled Trials ISRCTN16104753     

氨甲环酸用于减少产后出血量的临床研究

目的：探讨抗纤溶药物氨甲环酸注射液用于减少产后出血量的效果和安全性,方法：选择足月妊娠、阴道分娩的单胎、头位妇产妇400例,在分娩第二产程胎肩娩出后常规静脉注射缩宫素10U,随后随机分为4组,第1组（94例）静脉滴注氨甲环酸1．0g;第2组（92例）静脉滴注氨甲环酸0．5g;第3组（92例）静脉滴注国产止血芳酸0．5g;第4组（87例）为未作任何处理的对照组,另35例产妇因分娩巨大儿会影响产后出血量的计算而剔除。用容积法和称重法分别测量4组产妇胎盘娩出即时出血量和产后2h内出血量,两部分相加和总出血量。结果：（1）胎盘娩出即时出血量4组之间比较,差异无显著性（P＞0．05）。（2）产后2h出血量和总出血量4例之间比较;第1组分别为129．7ml和243．3ml;第2组分别为133．9ml和242．9ml;第3组分别为168．5ml和308．1ml;第4组分别为178．2ml和314．8ml。第1、2组与第3、4组相比,差异有极显著性（P＜0．01）;第1组产妇产后出血量少于第2组,但差异无显著性（P＞0．05）。（3）产后出血（≥400ml）发生率,第1组6．4％;第2组13．0％,第3组20．7％;第4组25．3％。（4）4组产妇均未出现明显的副作用。结论：氨甲环酸用于产后出血的治疗是安全有效的,其中1．0g剂量对减少产后出血量的效果最好,0．5g剂量的效果次之。     

Home use of two doses of misoprostol after mifepristone for medical abortion: A pilot study in Sweden and France

Objective To test the feasibility, safety, and efficacy of home use of two doses of misoprostol for medical abortion (MA) in European settings.

Methods One hundred thirty women (100 in Sweden, 30 in France) presenting for first-trimester MA were administered oral mifepristone in the clinic and sent home with two 400 μg doses of misoprostol, along with instructions to take the misoprostol at 24 h intervals. Women were also asked to complete a daily symptom diary. Outcomes of interest included effectiveness, side-effects, and adherence to and acceptability of the home-use regimen.

Results Three women (all in France) were lost to follow-up. Of the remaining 127 women, 124 (98%) had a successful MA. All women adhered successfully to the home-use regimen, and satisfaction with home use was high (98%). Most women experienced noticeable, if transitory, side effects after both the first and second doses of misoprostol (97% and 94%, respectively).

Conclusions Misoprostol may successfully and satisfactorily be used at home as part of a MA regimen in European settings as it has been for years in the US. Further research to determine if two doses of misoprostol are more effective than a single dose would be useful.     

Physical health after childbirth and maternal depression in the first 12 months post partum: Results of an Australian nulliparous pregnancy cohort study

Objectiveto investigate the relationship between maternal physical health problems and depressive symptoms in the first year after childbirth.Designprospective pregnancy cohort study.SettingMelbourne, Victoria, Australia.Population1507 nulliparous women.Methodswomen were recruited from six public hospitals between six and 24 weeks gestation. Written questionnaires were completed at recruitment and at three, six and 12 months post partum.Outcome measuresEdinburgh Postnatal Depression Scale (EPDS); standardised measures of urinary and faecal incontinence, a checklist of symptoms for other physical health problems.Resultsoverall, 16.1% of women reported depressive symptoms during the first 12 months post partum, with point prevalence at three, six and 12 months post partum of 6.9%, 8.8% and 7.8% respectively. The most commonly reported physical health problems in the first three months were tiredness (67%), back pain (47%), breast problems (37%), painful perineum (30%), and urinary incontinence (29%). Compared with women reporting 0–2 health problems in the first three months post partum, women reporting 5 or more health problems had a six-fold increase in likelihood of reporting concurrent depressive symptoms at three months post partum (Adjusted OR=6.69, 95% CI=3.0–15.0) and a three-fold increase in likelihood of reporting subsequent depressive symptoms at 6–12 months post partum (Adjusted OR=3.43, 95% CI 2.1–5.5).Conclusionspoor physical health in the early postnatal period is associated with poorer mental health throughout the first 12 months post partum. Early intervention to promote maternal mental health should incorporate assessment and intervention to address common postnatal physical health problems.     

Improved obstetric management after implementation of a scaled-up quality improvement intervention: A nested before-after study in three public hospitals in Nepal

Background

We assessed the change in obstetric management after implementation of a quality improvement intervention, the Nepal Perinatal Quality Improvement Package (NePeriQIP).

Methods

The Nepal Perinatal Quality Improvement Package was a stepped-wedge cluster-randomized controlled trial conducted in 12 public hospitals in Nepal between April 2017 and October 2018. In this study, three hospitals allocated at different time points to the intervention were selected for a nested before–after analysis. We used bivariate and multivariate analyses to compare obstetric management in the control vs intervention group.

Results

There were 25 977 deliveries in the three hospitals during the study period: 10 207 (39%) in the control and 15 770 (61%) in the intervention group. After adjusting for maternal age, ethnicity, education, gestational age, stage of labor at admission, complications during labor, and birthweight, the intervention group had a higher proportion of fetal heart rate monitoring performed as per protocol (adjusted odds ratio [aOR] 1.19, 95% confidence interval [CI] 1.12–1.27), shorter time intervals between each fetal heart rate monitoring (aOR 2.09, 95% CI 1.96–2.23), a higher likelihood of abnormal fetal heart rate being detected (aOR 1.53, 95% CI 1.25–1.68), progress of labor more often being recorded immediately after per vaginal examination (aOR 2.73, 95% CI 2.55–2.93), and partograph filled as per standards (aOR 3.18, 95% CI 2.98–3.50). The cesarean birth rate was 2.5% in the control group and 8.2% in the intervention group (aOR 3.12, 95% CI 2.64–3.68).

Conclusions

The NePeriQIP intervention has potential to improve obstetric care, especially intrapartum fetal surveillance, in similar low-resource settings.     

Trauma-sensitive yoga as an adjunct mental health treatment in group therapy for survivors of domestic violence: A feasibility study

This study is a feasibility test of whether incorporating trauma-sensitive yoga into group therapy for female victims of partner violence improves symptoms of anxiety, depression, and posttraumatic stress disorder (PTSD) beyond that achieved with group therapy alone. Seventeen (9 control, 8 intervention) adult female clients seeking group psychotherapy were enrolled.A 12-week trauma-sensitive yoga protocol was administered once weekly for 30–40 min at the end of each group therapy session. The control group received typical group psychotherapy. Feasibility was assessed through recruitment and retention rates as well as participants' self-reported perceptions of the safety and utility of the study. The study enrolled 85% (17/20) of those screened eligible. Loss to follow-up was 30% (5/17). No one reported emotional or physical harm. All of the respondents reported that the study was personally meaningful and that the results would be useful to others.     

Views of emergency research (VERA): A qualitative study of women and their partners' views of recruitment to trials in severe postpartum haemorrhage

Objective

to explore women's and their partners' views of recruitment to emergency trials in severe postpartum haemorrhage (PPH).

Design

interview-based qualitative study. In semi-structured in-depth interviews, five recruitment options for a PPH trial in an emergency context were considered.

Setting

interviews were carried out in participants' homes.

Participants

nine women who had experienced a severe PPH and six partners.

Findings

interviewees rejected three options; decision-making by women prior to delivery, and by partners and legal representatives at the time of the emergency. Preferred options were women making antenatal decisions about trial entry themselves, followed by doctors making decisions at the time of the emergency.

Conclusions and implications for practice

recruitment options involving women and their partners at the time of an emergency were rejected. Antenatal decision-making raises logistical and ethical considerations for emergency trial teams. Further research is needed to address the possibility of antenatal decisions for emergency trials and to develop and assess supportive post-enrolment recruitment and information strategies which take into account the stressful context of clinical emergencies such as PPH.     

Use of the Optimality Index-United States in perinatal clinical research: a validation study

The objective of this study was to assess the validity and observed effect size of a new instrument, the Optimality Index-United States (OI-US), for use in perinatal clinical research. Using a large, hospital-based, midwifery service clinical database that included complete obstetric data for 3425 women, we examined discriminant validity and the effects of two different scoring methods used with the OI-US. Discriminant validity was confirmed by comparing OI scores for women who remained low risk and did not require physician involvement in their care (OI score mean = 84%; standard deviation [SD] = 8%) compared to those whose condition changed to require physician involvement in their care (mean = 71%; SD = 10%; P < .001). Two methods of scoring the OI-US were compared, finding no significant difference and suggesting that the types of data available and the research question can drive this decision. Finally, effect size was calculated by two methods: Cohen's d (-1.4) and the effect size correlation (r = -0.548), the latter of which corresponds to a d of -1.3, both resulting in a similarly large effect size estimation. The OI-US is a new instrument that shows promise for use in perinatal clinical research, particularly when assessing more subtle clinical differences in outcomes between study groups.