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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Administration of 400 μg of misoprostol to augment routine active management of the third stage of labor
International Journal of Gynecology and Obstetrics, Volume 112, No. 2, Year 2011
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Description
Objective: To assess the effectiveness and safety of the administration of misoprostol, an orally active prostaglandin, in addition to routine uterotonic therapy as part of the active management of the third stage of labor. Methods: The present study was a hospital-based, decentralized, multi-center, randomized, placebo-controlled, double-blind trial. We enrolled 1103 women (out of a target sample size of 1180) at 4 hospitals in South Africa, Uganda, and Nigeria. Participants received a sublingual dose of 400 μg of misoprostol or a placebo, in addition to standard active management of the third stage of labor, after vaginal birth. Results: The baseline characteristics of the participants were comparable. The difference in the primary outcome of blood loss of 500 mL or more within 1 hour of randomization was not significant between the 2 groups (misoprostol 22/546 [4.0%] versus placebo 35/553 [6.3%]; relative risk, 0.64; 95% confidence interval, 0.38-1.07). Shivering and pyrexia occurred more frequently in the misoprostol group. No maternal deaths occurred. Conclusion: The present study did not confirm a beneficial effect of administering 400 μg of misoprostol, in addition to routine uterotonic therapy, during the third stage of labor, but was consistent with other trials showing a cumulative modest benefit. Where routine uterotonics are available for prophylactic use, any potential benefit of misoprostol might not outweigh the likelihood of adverse effects. Trial registered on clinical trials.gov: NCT 00124540. © 2010 International Federation of Gynecology and Obstetrics.
Authors & Co-Authors
Hofmeyr, George Justus
United Kingdom, London
The Royal London Hospital
South Africa, Alice
University of Fort Hare
South Africa, Johannesburg
University of the Witwatersrand
Fawole, Bukola O.
Nigeria, Ibadan
University College Hospital, Ibadan
Mugerwa, Kidza Yvonne
Uganda, Kampala
Mulago Hospital
Godi, N. P.
South Africa, Mbombela
Rob Ferreira Hospital, Nelspruit
Blignaut, Quentin
South Africa, Port Elizabeth
Dora Nginza Hospital
Mangesi, Lindeka
United Kingdom, London
The Royal London Hospital
South Africa, Alice
University of Fort Hare
South Africa, Johannesburg
University of the Witwatersrand
Singata-Madliki, Mandisa
United Kingdom, London
The Royal London Hospital
South Africa, Alice
University of Fort Hare
South Africa, Johannesburg
University of the Witwatersrand
Brady, Leanne
United Kingdom, London
The Royal London Hospital
South Africa, Alice
University of Fort Hare
South Africa, Johannesburg
University of the Witwatersrand
Blum, Jennifer
United States, New York
Gynuity Health Projects
Statistics
Citations: 23
Authors: 9
Affiliations: 8
Identifiers
Doi:
10.1016/j.ijgo.2010.08.019
ISSN:
00207292
Research Areas
Disability
Health System And Policy
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Nigeria
South Africa
Uganda
Participants Gender
Female