Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Jan;123(1):120-7.
doi: 10.1111/1471-0528.13540. Epub 2015 Sep 1.

Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster-randomised non-inferiority community trial

S Raghavan  1 , S Geller  2 , S Miller  3 , S S Goudar  4 , H Anger  1 , M C Yadavannavar  5 , R Dabash  1 , S R Bidri  5 , M R Gudadinni  5 , R Udgiri  5 , A R Koch  2 , M B Bellad  4 , B Winikoff  1
Affiliations
Randomized Controlled Trial

Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster-randomised non-inferiority community trial

S Raghavan et al. BJOG. 2016 Jan.

Abstract

Objective: To assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.

Design: A cluster-randomised non-inferiority community trial.

Setting: Health sub-centres and home deliveries in the Bijapur district of Karnataka, India.

Population: Women with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.

Methods: Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.

Main outcome measures: Postpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.

Results: Misoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).

Conclusion: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.

Tweetable abstract: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.

Keywords: Misoprostol; postpartum haemorrhage; primary prevention; secondary prevention.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Non‐inferiority of secondary prevention relative to primary prevention. The diamond represents the point estimate of the difference in the primary outcome and the horizontal bar represents the one‐sided 95% CI for testing non‐inferiority. Non‐inferiority would be accepted if the 95% CI falls below the pre‐defined non‐inferiority margin of 7%.
Figure 3
Figure 3
Postpartum blood loss.
See this image and copyright information in PMC

Comment in

References

    1. World Health Organization . Managing Complications in Pregnancy and Childbirth: A Guide for Midwives and Doctors. Department of Reproductive Health and Research. Geneva: World Health Organization, 2003.
    1. Dabash R, Blum J, Raghavan S, Anger H, Winikoff B. Misoprostol for the management of postpartum bleeding: a new approach. Int J Gynaecol Obstet 2012;119:210–2. - PubMed
    1. Walraven G, Blum J, Dampha Y, Sowe M, Morison L, Winikoff B, et al. Misoprostol in the management of third stage labour in the home delivery setting in rural Gambia: a randomised controlled trial. BJOG 2005;112:1277–83. - PubMed
    1. Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, et al. Oral misoprostol in preventing postpartum haemorrhage in resource‐poor communities: a randomised controlled trial. Lancet 2006;368:1248–53. - PubMed
    1. Mobeen N, Durocher J, Zuberi NF, Jahan N, Blum J, Wasim S, et al. Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo‐controlled trial. BJOG 2011;118:353–61. - PMC - PubMed

Publication types

LinkOut - more resources