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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Misoprostol as an adjunct to standard uterotonics for treatment of post-partum haemorrhage: a multicentre, double-blind randomised trial
The Lancet, Volume 375, No. 9728, Year 2010
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Description
Background: Post-partum haemorrhage is a leading cause of global maternal morbidity and mortality. Misoprostol, a prostaglandin analogue with uterotonic activity, is an attractive option for treatment because it is stable, active orally, and inexpensive. We aimed to assess the effectiveness of misoprostol as an adjunct to standard uterotonics compared with standard uterotonics alone for treatment of post-partum haemorrhage. Methods: Women delivering vaginally who had clinically diagnosed post-partum haemorrhage due to uterine atony were enrolled from participating hospitals in Argentina, Egypt, South Africa, Thailand, and Vietnam between July, 2005, and August, 2008. Computer-generated randomisation was used to assign women to receive 600 μg misoprostol or matching placebo sublingually; both groups were also given routine injectable uterotonics. Allocation was concealed by distribution of sealed and sequentially numbered treatment packs in the order that women were enrolled. Providers and women were masked to treatment assignment. The primary outcome was blood loss of 500 mL or more within 60 min after randomisation. Analysis was by intention to treat. This study is registered, number ISRCTN34455240. Findings: 1422 women were assigned to receive misoprostol (n=705) or placebo (n=717). The proportion of women with blood loss of 500 mL or more within 60 min was similar between the misoprostol group (100 [14%]) and the placebo group (100 [14%]; relative risk 1·02, 95% CI 0·79-1·32). In the first 60 min, an increased proportion of women on misoprostol versus placebo, had shivering (455/704 [65%] vs 230/717 [32%]; 2·01, 1·79-2·27) and body temperature of 38°C or higher (303/704 [43%] vs 107/717 [15%]; 2·88, 2·37-2·50). Interpretation: Findings from this study do not support clinical use of 600 μg sublingual misoprostol in addition to standard injectable uterotonics for treatment of post-partum haemorrhage. Funding: Bill & Melinda Gates Foundation, and UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. © 2010 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Widmer, Mariana C.
United States, Washington, D.c.
The World Bank, Usa
Blum, Jennifer
United States, New York
Gynuity Health Projects
Hofmeyr, George Justus
South Africa, Bisho
Eastern Cape Department of Health
Carroli, Guillermo
Argentina, Rosario
Centro Rosarino de Estudios Perinatales
Abdel-Aleem, Hany
Egypt, Asyut
Assiut University
Lumbiganon, Pisake
Thailand, Khon Kaen
Khon Kaen University
Ngoc, Nguyen Thi Nhu
Viet Nam, Ho Chi Minh City
Hung Vuong Hospital
Wojdyla, Daniel
Argentina, Rosario
Centro Rosarino de Estudios Perinatales
Thinkhamrop, Jadsada
Thailand, Khon Kaen
Khon Kaen University
Singata-Madliki, Mandisa
South Africa, Bisho
Eastern Cape Department of Health
Mignini, Luciano E.
Argentina, Rosario
Centro Rosarino de Estudios Perinatales
Abdel-Aleem, M. A.
Egypt, Asyut
Assiut University
Thach, Tran Son
Viet Nam, Ho Chi Minh City
Hung Vuong Hospital
Winikoff, Beverly
United States, New York
Gynuity Health Projects
Statistics
Citations: 81
Authors: 14
Affiliations: 7
Identifiers
Doi:
10.1016/S0140-6736(10)60348-0
ISSN:
01406736
Research Areas
Disability
Maternal And Child Health
Study Design
Case-Control Study
Study Locations
Egypt
South Africa
Participants Gender
Female