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      Effect on Postpartum Hemorrhage of Prophylactic Oxytocin (10 IU) by Injection by Community Health Officers in Ghana: A Community-Based, Cluster-Randomized Trial

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          Abstract

          Cynthia Stanton and colleagues conducted a cluster-randomized controlled trial in rural Ghana to assess whether oxytocin given by injection by community health officers at home births was a feasible and safe option in preventing postpartum hemorrhage.

          Please see later in the article for the Editors' Summary

          Abstract

          Background

          Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births.

          Methods and Findings

          This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27–0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18–0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7–72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls.

          Conclusion

          Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births.

          Trial registration

          ClinicalTrials.gov NCT01108289

          Please see later in the article for the Editors' Summary

          Editors' Summary

          Background

          Many women in low-and middle-income countries die unnecessarily during childbirth, even though the solutions to prevent or manage complications are well known. Maternal death rates are highest amongst poor women living in remote areas, as they are least likely to have access to adequate health care. One of the United Nation's Millennium Development Goals is to reduce maternal death rates by three-quarters by 2015. Between 1990 and 2010, these rates were nearly halved. So there is still some way to go to meet the target.

          One of the major causes of maternal death is excessive bleeding after birth, known as postpartum hemorrhage (PPH). The highest rates of PPH are found in Africa (28% of births), with an overall global rate of 11%. PPH can be caused by the uterus not contracting after the baby is born, damage to tissues and blood vessels, retention of the placenta, and problems with blood-clotting.

          PPH can be prevented by an injection of oxytocin (a hormone) or with tablets of the drug misoprostol immediately after birth. Other drugs exist but are used much less frequently in low-income countries. If the mother does bleed excessively, then these interventions can also be used to treat PPH in the hours following birth. These drugs cause the uterus to contract. Continued severe bleeding requires emergency treatment in hospital. The World Health Organization (WHO) recommends that in situations where women give birth without the assistance of a trained midwife, priority should be given to preventing PPH because access to emergency services may be limited.

          Why Was This Study Done?

          Of the two most common options for preventing PPH, oxytocin is generally the preferred choice. It has the advantage of having no side effects, whereas misoprostol can cause fever and shivering. A repeat injection of oxytocin can also be given if the mother continues to bleed excessively, whereas a dose of misoprostol after birth should only be given once. A major concern about both drugs is that the timing of administration must be precise. Giving a drug that causes the uterus to contract before birth can be harmful to both mother and baby. A disadvantage of oxytocin is that it requires someone trained and authorized to give an injection. For this reason, oxytocin has so far been generally limited to hospitals and clinics, where it can be administered by medically trained professionals. Another disadvantage is that oxytocin is weakened by heat, which means its storage and use may be impractical in hot countries.

          The main aim of this study was therefore to find out whether health workers without midwifery skills are able to administer oxytocin safely when attending home births in poor, rural communities.

          What Did the Researchers Do and Find?

          The researchers carried out a cluster-randomized controlled trial in four rural districts in Ghana, working with community health officers (CHOs). CHOs are trained for two years in giving childhood immunizations and antenatal and postnatal care, but are not trained midwives. 54 CHOs were randomized to one of two groups. The CHOs in the first group gave a preventative oxytocin injection to the mother at every birth they attended. The oxytocin was administered using a pre-filled, disposable device called Uniject that is easier and quicker to use than a syringe and needle. The packaging also included a heat-sensitive label that indicated whether the oxytocin still met the manufacturer's criteria for an acceptably potent drug. CHOs in the second group acted as controls, and did not give any oxytocin injections to prevent PPH. The women seen by each CHO formed a cluster. Comparisons were made across the clusters of women that either received or did not receive the preventative intervention.

          The researchers found that the women who were given a preventative oxytocin injection lost less blood after birth than the women who did not receive a preventative injection. There were also fewer cases of PPH amongst the women who received oxytocin for PPH prevention. 2.6% of the women who received a preventative oxytocin injection experienced PPH, compared to 5.5% of the controls. Therefore the risk of PPH was approximately halved. There were no cases of oxytocin use before delivery of the baby and no difference in the frequency of other birth complications between women in the intervention and control groups.

          What Do These Findings Mean?

          These findings show that under the trial conditions, CHOs can safely administer oxytocin injections when attending home births in poor, rural settings. This intervention also proved practical to use in the Uniject format.

          The study therefore suggests that oxytocin should be considered for use in regions where maternal deaths from PPH are still unacceptably high. There are also several noteworthy limitations, such as unblinding and the imbalance between participant groups. The researchers emphasized that their findings do not mean that oxytocin is always a better choice than misoprostol for home births. Many factors will influence which intervention is the most feasible, such as the local availability of sufficiently skilled health professionals, the relative cost and availability of the two drugs, as well as ease of access to emergency health services.

          Additional Information

          Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001524.

          Related collections

          Most cited references 11

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          WHO analysis of causes of maternal death: a systematic review.

          The reduction of maternal deaths is a key international development goal. Evidence-based health policies and programmes aiming to reduce maternal deaths need reliable and valid information. We undertook a systematic review to determine the distribution of causes of maternal deaths. We selected datasets using prespecified criteria, and recorded dataset characteristics, methodological features, and causes of maternal deaths. All analyses were restricted to datasets representative of populations. We analysed joint causes of maternal deaths from datasets reporting at least four major causes (haemorrhage, hypertensive disorders, sepsis, abortion, obstructed labour, ectopic pregnancy, embolism). We examined datasets reporting individual causes of death to investigate the heterogeneity due to methodological features and geographical region and the contribution of haemorrhage, hypertensive disorders, abortion, and sepsis as causes of maternal death at the country level. 34 datasets (35,197 maternal deaths) were included in the primary analysis. We recorded wide regional variation in the causes of maternal deaths. Haemorrhage was the leading cause of death in Africa (point estimate 33.9%, range 13.3-43.6; eight datasets, 4508 deaths) and in Asia (30.8%, 5.9-48.5; 11,16 089). In Latin America and the Caribbean, hypertensive disorders were responsible for the most deaths (25.7%, 7.9-52.4; ten, 11,777). Abortion deaths were the highest in Latin America and the Caribbean (12%), which can be as high as 30% of all deaths in some countries in this region. Deaths due to sepsis were higher in Africa (odds ratio 2.71), Asia (1.91), and Latin America and the Caribbean (2.06) than in developed countries. Haemorrhage and hypertensive disorders are major contributors to maternal deaths in developing countries. These data should inform evidence-based reproductive health-care policies and programmes at regional and national levels. Capacity-strengthening efforts to improve the quality of burden-of-disease studies will further validate future estimates.
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            Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial.

            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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              Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial

              Objective To determine if misoprostol is safe and efficacious in preventing postpartum haemorrhage (PPH) when administered by trained traditional birth attendants (TBA) at home deliveries. Design A randomised, double-blind, placebo-controlled trial. Setting Chitral, Khyber Pakhtunkhwa Province, Pakistan. Population A total of 1119 women giving birth at home. Methods From June 2006 to June 2008, consenting women were randomised to receive 600 μg oral misoprostol (n = 534) or placebo (n = 585) after delivery to determine whether misoprostol reduced the incidence of PPH (≥500 ml). Main outcome measures The primary outcomes were measured blood loss ≥500 ml after delivery and drop in haemoglobin >2 g/dl from before to after delivery. Results Oral misoprostol was associated with a significant reduction in the rate of PPH (≥500 ml) (16.5 versus 21.9%; relative risk 0.76, 95% CI 0.59–0.97). There were no measurable differences between study groups for drop in haemoglobin >2 g/dl (relative risk 0.79, 95% CI 0.62–1.02); but significantly fewer women receiving misoprostol had a drop in haemoglobin >3 g/dl, compared with placebo (5.1 versus 9.6%; relative risk 0.53, 95% CI 0.34–0.83). Shivering and chills were significantly more common with misoprostol. There were no maternal deaths among participants. Conclusions Postpartum administration of 600 μg oral misoprostol by trained TBAs at home deliveries reduces the rate of PPH by 24%. Given its ease of use and low cost, misoprostol could reduce the burden of PPH in community settings where universal oxytocin prophylaxis is not feasible. Continual training and skill-building for TBAs, along with monitoring and evaluation of programme effectiveness, should accompany any widespread introduction of this drug. Trial registration http://clinicaltrials.gov/NCT00120237 Misoprostol for the Prevention of Postpartum Hemorrhage in Rural Pakistan.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS Med
                PLoS Med
                PLoS
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, USA )
                1549-1277
                1549-1676
                October 2013
                October 2013
                1 October 2013
                : 10
                : 10
                Affiliations
                [1 ]Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
                [2 ]Kintampo Health Research Centre, Ghana Health Service, Kintampo, Ghana
                [3 ]PATH, Ghana, Accra, Ghana
                [4 ]Research Triangle Institute, North Carolina, United States of America
                [5 ]PATH, Seattle, Washington, United States of America
                [6 ]United States Agency for International Development, Washington (DC), United States of America
                [7 ]School of Public Health, University of Ghana, Accra, Ghana
                The University of Adelaide, Australia
                Author notes

                The authors have declared that no competing interests exist.

                Conceived and designed the experiments: CS LM SN DA JG PC SO. Analyzed the data: LM CS. Wrote the first draft of the manuscript: CS. Contributed to the writing of the manuscript: CS SN LM PC CA EA SA ND SK DA JG SO. ICMJE criteria for authorship read and met: CS SN LM PC CA EA SA ND SK DA JG SO. Agree with manuscript results and conclusions: CS SN LM PC CA EA SA ND SK DA JG SO.

                Article
                PMEDICINE-D-13-01168
                10.1371/journal.pmed.1001524
                3794862
                24130463

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Pages: 14
                Funding
                This research was sponsored by PATH with funding from the Bill & Melinda Gates Foundation. Collaborators include the Johns Hopkins Bloomberg School of Public Health, the Kintampo Health Research Center, and Research Triangle Institute. The funders of this study played no role in the design, data collection, data analysis, interpretation, drafting of the manuscript, or decision to submit the paper for publication.
                Categories
                Research Article

                Medicine

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