Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: randomised double blind clinical trial

Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: randomised double blind clinical trial
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DOI:
10.1136/bmj.331.7519.723
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发表时间:
2005-10-01
影响因子:
105.7
通讯作者:
Aaby, P
Aaby, P
中科院分区:
医学1区
文献类型:
--
作者:
Hoj, L;Cardoso, P;Aaby, P

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目的评价产后常规舌下含服米索前列醇600 μ g是否能减少产后出血。设计随机双盲安慰剂对照试验。地点位于西非几内亚比绍的比绍初级卫生中心。参与者661名阴道分娩的妇女。产后立即舌下含服米索前列醇600 μ g或安慰剂。主要结局指标产后出血,结果米索前列醇组与安慰剂组产后出血的发生率无显著差异,米索前列醇组与安慰剂组产后出血的相对危险度为0.89(95%可信区间0.76 ~ 1.04)。米索前列醇组的平均失血量比对照组低10.5%(-0.5%至20.4%)。重度产后出血≥ 1000 ml或≥ 1500 ml,安慰剂组分别为17%(56)和8%(25),米索前列醇组分别为11%(37)和2%(7)。米索前列醇组女性尿量减少>= 1000 ml(0.66,0.45 - 0.98)或>= 1500 ml(0.28,0.12 - 0.64)的女性明显较少。米索前列醇组的血红蛋白浓度下降幅度较小,两组之间的平均差异为0.16 mmol/l(-0.01 mmol/l至0.32 mmol/l)。
Objective To evaluate whether routine administration of sublingual misoprostol 600 mu g after delivery reduces postpartum haemorrhage.Design Randomised double blind placebo controlled trial.Setting Primary health centre in Bissau, Guinea-Bissau, West Africa.Participants 661 women undergoing vaginal delivery.Intervention Misoprostol 600 mu g or placebo administered sublingually immediately after delivery.Main outcome measures Postpartum haemorrhage, defined as a loss of >= 500 ml and decrease in haemoglobin concentration after delivery.Results The incidence of postpartum haemorrhage was not significantly different between the two groups, the relative risk being 0.89 (95% confidence interval 0.76 to 1.04) in the misoprostol group compared with the placebo group. Mean blood loss was 10.5% (- 0.5% to 20.4%) lower in the misoprostol group than in the control group. Severe postpartum haemorrhage of >= 1000 ml or >= 1500 ml occurred in 17% (56) and 8% (25) in the placebo group and 11% (37) and 2% (7) in the misoprostol group. Significantly fewer women in the misoprostol group experienced a loss of >= 1000 ml (0.66,0.45 to 0.98) or >= 1500 ml (0.28, 0.12 to 0.64). The decrease in haemoglobin concentration tended to be less in the misoprostol group, the mean difference between the two groups being 0.16 mmol/l (- 0.01 mmol/l to 0.32 mmol/l).Conclusion Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage.