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静脉注射卡贝缩宫素与静脉注射缩宫素预防高危单胎阴道分娩后宫缩乏力性产后出血的效果比较:一项三盲随机对照试验。

Intravenous carbetocin versus intravenous oxytocin for preventing atonic postpartum hemorrhage after normal vaginal delivery in high-risk singleton pregnancies: a triple-blind randomized controlled trial.

机构信息

Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Arch Gynecol Obstet. 2018 Aug;298(2):319-327. doi: 10.1007/s00404-018-4806-5. Epub 2018 Jun 18.

Abstract

PURPOSE

To compare the effectiveness of intravenous carbetocin to that of intravenous oxytocin for prevention of atonic postpartum hemorrhage (PPH) after vaginal delivery in high-risk singleton pregnancies.

METHODS

This triple-blind randomized controlled trial included singleton pregnant women who delivered at Siriraj Hospital between August 2016 and January 2017 and who were 20 years or older, had a gestational age of at least 34 weeks, had a vaginal delivery, and had at least one risk factor for atonic postpartum hemorrhage. Immediately after vaginal delivery, participants were randomly assigned to receive either 5 U of oxytocin or 100 mcg of carbetocin intravenously. Postpartum blood loss was measured objectively in mL using a postpartum drape with a calibrated bag.

RESULTS

A total of 174 and 176 participants constituted the oxytocin and carbetocin groups, respectively. The baseline characteristics were comparable between the groups. The carbetocin group had less postpartum blood loss (146.7 ± 90.4 vs. 195.1 ± 146.2 mL; p < 0.01), a lower incidence of atonic PPH (0 vs. 6.3%; p < 0.01), less usage of additional uterotonic drugs (9.1 vs. 27.6%; p < 0.01), and a lower incidence of postpartum anemia (Hb ≤ 10 g/dL) (9.1 vs. 18.4%; p < 0.05) than the oxytocin group. No significant differences regarding side effects were evident between the groups.

CONCLUSIONS

Intravenous carbetocin is more effective than intravenous oxytocin for the prevention of atonic PPH among singleton pregnancies with at least one risk factor for PPH.

CLINICAL TRIAL REGISTRATION

TCTR20160715004.

摘要

目的

比较卡贝缩宫素静脉注射与催产素静脉注射预防高危单胎妊娠阴道分娩后宫缩乏力性产后出血(PPH)的效果。

方法

本三盲随机对照试验纳入 2016 年 8 月至 2017 年 1 月在诗里拉吉医院分娩且年龄≥20 岁、孕周≥34 周、行阴道分娩且至少存在 1 种宫缩乏力性产后出血高危因素的单胎妊娠孕妇。孕妇分娩后立即静脉注射 5U 催产素或 100μg 卡贝缩宫素。使用带有校准袋的产后敷布客观测量产后出血量(mL)。

结果

催产素组和卡贝缩宫素组分别有 174 名和 176 名参与者。两组的基线特征具有可比性。卡贝缩宫素组产后出血量较少(146.7±90.4比 195.1±146.2mL;p<0.01)、宫缩乏力性 PPH 发生率较低(0比 6.3%;p<0.01)、额外使用宫缩剂的比例较低(9.1比 27.6%;p<0.01)、产后贫血(Hb≤10g/dL)发生率较低(9.1比 18.4%;p<0.05)。两组不良反应发生率无显著差异。

结论

对于存在至少 1 种 PPH 高危因素的单胎妊娠孕妇,卡贝缩宫素静脉注射预防宫缩乏力性 PPH 的效果优于催产素静脉注射。

临床试验注册

TCTR20160715004。

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