Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial
Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial
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DOI：
10.1016/s0140-6736(06)69522-6
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发表时间：
2006-10-07
期刊：
影响因子：
168.9
通讯作者：
Moss, Nancy
中科院分区：
文献类型：
--
作者：
Derman, Richard J.;Kodkany, Bhalchandra S.;Moss, Nancy
背景产后出血是发展中国家孕产妇死亡的主要原因。虽然存在预防和治疗此类出血的有效方法，如子宫收缩药催产素，但大多数方法在资源匮乏的环境中不可行，因为许多分娩都是在家中进行的。我们的目的是调查是否口服米索前列醇，催产素的潜在替代品，可以防止产后出血在社区家庭分娩setting.Methods在安慰剂对照试验之间进行，2002年9月，2005年12月，1620名妇女在印度农村随机接受口服米索前列醇（n=812）或安慰剂（n=808）分娩后。25名辅助护士助产士进行分娩，给予研究药物，并测量失血量。主要结局是分娩后2小时内急性产后出血（定义为出血>= 500 mL）的发生率。该试验在美国临床试验数据库（http：//www.example.com）中注册www.clinicaltrials.gov，编号为NCT 00097123。结果口服米索前列醇与急性产后出血率显著降低相关（12.0%至6.4%，p < 0.0001;相对危险度0.53 [95% CI 0.39-0.74]）和急性重度产后出血（1.2%至0.2%，p < 0.0001; 0.20 [0.04-0.91]。每18名接受治疗的妇女中，就有一例产后出血得到预防。米索前列醇还与平均产后失血量减少相关（262.3 mL至214.3 mL，p < 0.0001）。两组的产后出血率都随着时间的推移而下降，但安慰剂组的产后出血率仍显着较高。妇女服用米索前列醇。与对照组相比，口服米索前列醇与急性产后出血率和平均失血量的显著降低有关。该药物的低成本，易于管理，稳定性和积极的安全性使其成为资源匮乏环境中的一个很好的选择。
Background Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist-such as the uterotonic drug oxytocin - most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting.Methods In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as >= 500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www.clinicaltrials.gov) as number NCT00097123.Findings Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p < 0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p < 0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p < 0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol. had a higher rate of transitory symptoms of chills and fever than the control.Interpretation Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings.