Trial reportThe journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians2008
Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol.
Trial report in The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 6 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 6 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis.The Cochrane database of systematic reviews · 2025Pooled it
- Advance misoprostol distribution to pregnant women for preventing and treating postpartum haemorrhage.The Cochrane database of systematic reviews · 2020Pooled it
- Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis.The Cochrane database of systematic reviews · 2018Pooled it
- Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis.The Cochrane database of systematic reviews · 2018Pooled it
- Postpartum misoprostol for preventing maternal mortality and morbidity.The Cochrane database of systematic reviews · 2013Pooled it
- Prostaglandins for preventing postpartum haemorrhage.The Cochrane database of systematic reviews · 2012Pooled it
- Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster-randomised non-inferiority community trial.BJOG : an international journal of obstetrics and gynaecology · 2016Trial
- Trial
- Primary postpartum hemorrhage and associated factors among delivering women in Gedeo Zone, Southern Ethiopia.Frontiers in medicine · 2023Article
- Rethinking WHO guidance: review of evidence for misoprostol use in the prevention of postpartum haemorrhage.Journal of the Royal Society of Medicine · 2012Review
- Inability to predict postpartum hemorrhage: insights from Egyptian intervention data.BMC pregnancy and childbirth · 2011Article
Corrections and comments
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Authors and funding
14 authors at 6 institutions in 3 countries.
Funding
Abstract
objectiveThe main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss >or= 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study.
methodsWe conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n = 808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs); (2) the study duration, representing exposure of the ANM to ongoing training and monitoring; and (3) duration of the second stage of labor as a measure of improved delivery practices.
resultsAs the study duration increased, the duration of the second stage of labor decreased (-0.12, p = 0.001) and as the duration of the second stage of labor decreased, the rate of PPH decreased (0.0282; 95% CI 0.0201-0.0363). For each 10-minute increase in the duration of second stage labor increased PPH odds by 7.1% and each 30-day duration of the trial decreased PPH odds by 3.4%. Additionally, a patient delivered by an original ANM was 3.14 times more likely to have a PPH compared to a patient delivered by a replacement ANM.
conclusionsDeclining PPH rates were associated with improved skills and delivery practices that decreased duration of the second stage of labor. These improvements appeared to be consistent with the introduction of the more skilled replacement ANMs as well as ongoing training and monitoring for all ANMs over the duration of the trial.
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