Administration of 400 mu g of misoprostol to augment routine active management of the third stage of labor

作者：Hofmeyr G Justus^*; Fawole Bukola; Mugerwa Kidza; Godi N Patrick; Blignaut Quentin; Mangesi Lindeka; Singata Mandisa; Brady Leanne; Blum Jennifer

来源：International Journal of Gynecology & Obstetrics, 2011, 112(2): 98-102.

DOI：10.1016/j.ijgo.2010.08.019

• Misoprostol
• Postpartum hemorrhage
• Uterotonics

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 mu g 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 mu g 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.

• 出版日期2011-2