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      Oral misoprostol for preventing postpartum haemorrhage in home births in rural Bangladesh: how effective is it?

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          Abstract

          Aims

          Evidence exists about prevention of postpartum haemorrhage (PPH) by oral administration of misoprostol in low-income countries, but effectiveness of prevention by lay community health workers (CHW) is not sufficient. This study aimed to investigate whether a single dose (400 µg) of oral misoprostol could prevent PPH in a community home-birth setting and to assess its acceptability and feasibility among rural Bangladeshi women.

          Methods

          This quasi-experimental trial was conducted among 2,017 rural women who had home deliveries between November 2009 and February 2010 in two rural districts of northern Bangladesh. In the intervention district 1,009 women received 400 µg of misoprostol immediately after giving birth by the lay CHWs, and in the control district 1,008 women were followed after giving birth with no specific intervention against PPH. Primary PPH (within 24 hours) was measured by women's self-reported subjective measures of the normality of blood loss using the ‘cultural consensus model.’ Baseline data provided socio-economic, reproductive, obstetric, and bleeding disorder information.

          Findings

          The incidence of primary PPH was found to be lower in the intervention group (1.6%) than the control group (6.2%) ( p<0.001). Misoprostol provided 81% protection (RR: 0.19; 95% CI: 0.08–0.48) against developing primary PPH. The proportion of retained and manually removed placentae was found to be higher in the control group compared to the intervention group. Women in the control group were more likely to need an emergency referral to a higher level facility and blood transfusion than the intervention group. Unexpectedly few women experienced transient side effects of misoprostol. Eighty-seven percent of the women were willing to use the drug in future pregnancy and would recommend to other pregnant women.

          Conclusion

          Community-based distribution of oral misoprostol (400 µg) by CHW appeared to be effective, safe, acceptable, and feasible in reducing the incidence of PPH in rural areas of Bangladesh. This strategy should be scaled up across the country where access to skilled attendance is limited.

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          Most cited references36

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          Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

          Richard J Derman, Mrutyunjaya B Bellad, Stanley Edlavitch … (2006)
          Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting. In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123. Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control. Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.
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            WHO multicentre randomised trial of misoprostol in the management of the third stage of labour.

            Doreen Hofmeyr, P Lumbiganon, T. Ngoc … (2001)
            Postpartum haemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labour, including use of a uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. We did a multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour. In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, we randomly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labour. The primary outcomes were measured postpartum blood loss of 1000 mL or more, and the use of additional uterotonics without an unacceptable level of side-effects. We chose an upper limit of a 35% increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat. 9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 mL or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% CI 1.19-1.63], p<0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p<0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15-3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery. 10 IU oxytocin (intravenous or intramuscular) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital settings where active management is the norm.
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              Prevention of postpartum hemorrhage at home birth in Afghanistan.

              Ndola J V Prata, T Ehsan, Harshadkumar Sanghvi … (2010)
              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. A nonrandomized experimental control design in rural Afghanistan. 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. 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.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Glob Health Action
                Journal ID (publisher-id): GHA
                Title: Global Health Action
                Publisher: CoAction Publishing
                ISSN (Print): 1654-9716
                ISSN (Electronic): 1654-9880
                Publication date (Electronic): 10 August 2011
                Publication date Collection: 2011
                Volume: 4
                Electronic Location Identifier: 10.3402/gha.v4i0.7017
                Affiliations
                [1 ]Research and Evaluation Division, BRAC Centre, Dhaka, Bangladesh
                [2 ]Department of Family and Community Medicine, King Khalid University Abha, Kingdom of Saudi Arabia
                [3 ]BRAC Health Programme, BRAC Centre, Dhaka, Bangladesh
                [4 ]Umeå Centre for Global Health Research, Umeå University, Umeå, Sweden and IMMPACT, University of Aberdeen, Aberdeen, Scotland
                Author notes
                [* ] Hashima-E-Nasreen, Research and Evaluation Division, BRAC Centre, 75 Mohakhali, Dhaka 1212, Bangladesh. Tel: +88 02 8824180 ext. 2708. Fax: +88 02 8823542. Email: nasreen.h@ 123456brac.net
                Article
                Publisher ID: GHA-4-7017
                DOI: 10.3402/gha.v4i0.7017
                PMC ID: 3154679
                PubMed ID: 21845143
                SO-VID: d3903552-22b9-4364-855a-a9b06c2e29cc
                Copyright © © 2011 Hashima-E-Nasreen et al.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 05 March 2011
                Date revision received : 13 June 2011
                Date accepted : 18 July 2011
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Health & Social care
                Keywords: rural bangladesh,brac,misoprostol,prevention of postpartum haemorrhage
                Data availability:
                ScienceOpen disciplines: Health & Social care
                Keywords: rural bangladesh, brac, misoprostol, prevention of postpartum haemorrhage

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