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术前直肠米索前列醇预防择期剖宫产术中及术后失血的安全性和有效性的随机对照试验。

A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery.

机构信息

Department of Obstetrics and Gynecology, Kasr Al-Ainy Hospital, Cairo University, Cairo, Egypt.

Al Azhar University, Cairo, Egypt.

出版信息

Int J Gynaecol Obstet. 2019 Oct;147(1):102-107. doi: 10.1002/ijgo.12922. Epub 2019 Jul 25.

Abstract

OBJECTIVE

To assess the safety and efficacy of preoperative rectal misoprostol for the prevention of intraoperative and postoperative blood loss in women undergoing elective cesarean delivery.

METHODS

A single-blind randomized controlled trial of 200 full-term pregnant women scheduled for elective cesarean delivery. Computer-generated randomization allocated women to receive 400 μg rectal misoprostol at urinary catheter insertion plus 400 μg rectally after abdominal closure (preoperative group, n=100) or 800 μg of rectal misoprostol after abdominal closure (postoperative group, n=100). Primary outcome was intraoperative blood loss.

RESULTS

Intraoperative blood loss was significantly lower in the preoperative misoprostol group compared with the postoperative group (528.7 ± 114.8 mL vs 788.6 ± 165.8 mL; P<0.001). Blood loss during the first 24 hours after delivery was also lower in the preoperative group (199.3 ± 84.5 mL vs 302.9 ± 125.6 mL; P<0.001). Fewer women in the preoperative group needed additional uterotonics (7 vs 21; P<0.001). After delivery, the decrease in both hemoglobin and hematocrit levels was significantly less in the preoperative group (-6.8 vs -12.8% and -6.05 vs -17.8%, respectively; P<0.001).

CONCLUSION

Preoperative rectal administration of misoprostol significantly reduced intraoperative and postoperative blood loss during and after elective cesarean delivery. ClinicalTrial.gov ID: NCT03680339. Date of registration 9/2018.

摘要

目的

评估术前直肠给予米索前列醇预防择期剖宫产术中及术后失血的安全性和有效性。

方法

这是一项纳入 200 例择期行剖宫产术的足月孕妇的单盲随机对照试验。采用计算机生成的随机分组方法,将孕妇分为两组:在导尿时给予 400μg 米索前列醇直肠给药,腹部关闭后再给予 400μg(术前组,n=100)或腹部关闭后给予 800μg 米索前列醇直肠给药(术后组,n=100)。主要结局为术中失血量。

结果

与术后组相比,术前组米索前列醇组术中失血量明显减少(528.7±114.8ml 比 788.6±165.8ml;P<0.001)。产后 24 小时内的出血量也较低(199.3±84.5ml 比 302.9±125.6ml;P<0.001)。术前组需要额外使用宫缩剂的患者较少(7 例比 21 例;P<0.001)。产后,术前组血红蛋白和血细胞比容水平下降幅度明显较小(-6.8%比-12.8%和-6.05%比-17.8%;均 P<0.001)。

结论

术前直肠给予米索前列醇可显著减少择期剖宫产术中及术后的失血。ClinicalTrials.gov 注册号:NCT03680339。登记日期:2018 年 9 月。

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