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米索前列醇与常规缩宫素预防产后出血的双盲、随机、安慰剂对照试验。

A double-blind, randomized, placebo-controlled trial of misoprostol and routine uterotonics for the prevention of postpartum hemorrhage.

机构信息

Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria.

出版信息

Int J Gynaecol Obstet. 2011 Feb;112(2):107-11. doi: 10.1016/j.ijgo.2010.08.023. Epub 2010 Dec 4.

DOI:10.1016/j.ijgo.2010.08.023
PMID:21130446
Abstract

OBJECTIVE

To assess the effects of 400-μg sublingual misoprostol plus routine uterotonics on postpartum hemorrhage.

METHODS

A 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.

RESULTS

In 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.

CONCLUSION

Misoprostol 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.

摘要

目的

评估舌下含服 400μg 米索前列醇加常规宫缩剂对产后出血的影响。

方法

进行了一项双盲、安慰剂对照、随机研究。分娩后,符合条件的妇女接受常规宫缩剂,并随机分配接受舌下含服 400μg 米索前列醇或安慰剂。主要结局指标为服用试验片剂后 1 小时内出血量至少 500mL。

结果

共有 672 名妇女接受了米索前列醇治疗,673 名妇女接受了安慰剂治疗。两组的基线数据相似。米索前列醇加常规宫缩剂减少了产后出血量,但对于出血量至少 500mL(相对风险 [RR] 0.96;95%置信区间 [CI],0.63-1.45)或出血量至少 1000mL(RR 0.50;95% CI,0.15-1.66)的效果不显著。米索前列醇还减少了对非常规催产素、胎盘手动移除和子宫切除术的需求,但这些差异也不显著。米索前列醇与发热和中度/重度寒战有关。两组均无死亡病例。

结论

米索前列醇加常规宫缩剂可适度减少第三产程的出血量,但效果未达到统计学意义。建议进行更大规模的研究。

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