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Int J Gynaecol Obstet · Feb 2011
Randomized Controlled Trial Multicenter StudyA double-blind, randomized, placebo-controlled trial of misoprostol and routine uterotonics for the prevention of postpartum hemorrhage.
- Adeniran O Fawole, Oladapo S Sotiloye, Kehinde I Hunyinbo, Augustine C Umezulike, Michael A Okunlola, Daniel A Adekanle, Jonathan Osamor, Olusoji Adeyanju, Olufemi O Olowookere, Adeyemi O Adekunle, Mandisa Singata, Lindeka Mangesi, and George J Hofmeyr.
- Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria. fawoleo@yahoo.co.uk
- Int J Gynaecol Obstet. 2011 Feb 1; 112 (2): 107-11.
ObjectiveTo assess the effects of 400-μg sublingual misoprostol plus routine uterotonics on postpartum hemorrhage.MethodsA double-blind, placebo-controlled, randomized study was performed. After delivery of the child, eligible women received routine uterotonics and were randomly allocated to receive 400-μg misoprostol or placebo sublingually. The primary outcome measure was blood loss of at least 500 mL within 1 hour of taking the trial tablets.ResultsIn total, 672 women received misoprostol and 673 received placebo. The baseline data were similar for both groups. Misoprostol plus routine uterotonics reduced postpartum blood loss, but the effect was not significant for blood loss of at least 500 mL (relative risk [RR] 0.96; 95% confidence interval [CI], 0.63-1.45) or blood loss of at least 1000 mL (RR 0.50; 95% CI, 0.15-1.66). Misoprostol also reduced the need for non-routine oxytocin, manual removal of the placenta, and hysterectomy, but these differences were not significant either. Misoprostol was associated with pyrexia and moderate/severe shivering. There was no death in either group.ConclusionMisoprostol plus routine uterotonics resulted in modest reductions of blood loss in the third stage of labor, but the effects did not reach statistical significance. Larger studies are recommended.Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
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