Musa Abdulkarim O, Ijaiya Munir'deen A, Saidu Rakiya, Aboyeji Abiodun P, Jimoh Abiodun A, Adesina Kikelomo T, Abdul Ishaq F
Department of Obstetrics and Gynecology, Federal Medical Centre, Lokoja, Nigeria.
Department of Obstetrics and Gynecology, University of Ilorin/University of Ilorin Teaching Hospital, Ilorin, Nigeria.
Int J Gynaecol Obstet. 2015 Jun;129(3):227-30. doi: 10.1016/j.ijgo.2015.01.008. Epub 2015 Mar 20.
To compare the efficacy of oral misoprostol with that of oxytocin for active management of the third stage of labor (AMTSL).
A double-blind randomized control trial was undertaken at a center in Ilorin, Nigeria, between January and June 2013. Every other eligible patient (in the first stage of labor at term, to have a spontaneous vaginal delivery, and no/low risk of postpartum hemorrhage [PPH]) were randomly assigned with computer-generated random numbers to receive oral misoprostol (600μg) plus placebo injection or oral placebo plus oxytocin injection (1mL of 10IU) in the third stage of labor. The primary outcome was amount of blood loss during delivery.
Mean postpartum blood loss was 325.85±164.72mL in the 100 patients given misoprostol and 303.95±163.33mL in the 100 patients given oxytocin (P=0.391). PPH (≥500mL blood loss) was recorded in 15 (15.0%) patients given misoprostol and 14 (14.0%) given oxytocin (P=0.841). Shivering, pyrexia, and diarrhea were all significantly more common in the misoprostol group (P<0.01 for all).
The efficacy of oral misoprostol was similar to that of intramuscular oxytocin. Adverse effects associated with misoprostol were transient and self-limiting. Thus, oral misoprostol is efficacious and a good alternative to oxytocin for AMTSL. Pan African Clinical Trials Registry:PACTR201407000825227.
比较口服米索前列醇与缩宫素在积极处理第三产程（AMTSL）中的疗效。
2013年1月至6月在尼日利亚伊洛林的一个中心进行了一项双盲随机对照试验。每隔一名符合条件的患者（足月分娩第一产程，将自然阴道分娩，且无/低产后出血[PPH]风险）使用计算机生成的随机数随机分配，在第三产程接受口服米索前列醇（600μg）加安慰剂注射或口服安慰剂加缩宫素注射（1mL 10IU）。主要结局是分娩期间的失血量。
给予米索前列醇的100例患者产后平均失血量为325.85±164.72mL，给予缩宫素的100例患者为303.95±163.33mL（P = 0.391）。给予米索前列醇的患者中有15例（15.0%）记录到PPH（失血≥500mL），给予缩宫素的患者中有14例（14.0%）（P = 0.841）。米索前列醇组寒战、发热和腹泻均明显更常见（所有P<0.01）。
口服米索前列醇的疗效与肌肉注射缩宫素相似。与米索前列醇相关的不良反应是短暂的且有自限性。因此，口服米索前列醇对AMTSL有效，是缩宫素的良好替代药物。泛非临床试验注册中心：PACTR²⁰¹⁴⁰⁷⁰⁰⁰⁸²⁵²²⁷ 。
