卡贝托星与催产素预防高危妇女选择性剖宫产术后产后出血的前瞻性、随机、开放标签对照试验

IF 0.4 4区 医学 Q4 OBSTETRICS & GYNECOLOGY
Suya Kang, Liping Zhou, Li-ping Zhu, Yun Wang, Yongfei Yue, Li-ping Yan
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引用次数: 3

摘要

背景:比较卡贝托星和催产素预防中国高危妇女选择性剖宫产术后产后出血(PPH)的疗效和安全性。方法:这是一项单中心、前瞻性、随机、开放标签的对照试验,在2017年4月至2019年8月期间招募了852名有一种或多种PPH危险因素的孕妇。计划进行选择性剖宫产的孕妇被随机分配接受卡贝托星或催产素预防产后出血。主要疗效终点是额外的子宫收缩剂的比例。结果:共有852名孕妇被随机分配接受卡贝托星(n=442)或催产素(n=410)治疗。两组的基线特征具有可比性。与催产素组相比,卡贝托星组需要额外子宫收缩剂的比例较低(18.4%对24.4%,在全分析集[FAS]分析中p=0.03)。产时或产后的失血量无统计学意义(均p>0.05),两组在产后血红蛋白、止血率、输血、额外手术干预或子宫按摩方面无统计学意义。卡贝托星组和催产素组轻度窒息发生率分别为2.1%和1.3%。在两组中未观察到其他不良的产妇和新生儿结局。结论:在中国高危妇女选择性剖宫产术后,为了预防PPH,卡贝托星需要比催产素更低的额外子宫收缩剂。在产后失血、产后血红蛋白、止血、输血、额外手术干预或子宫按摩方面,卡贝托星与催产素相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Carbetocin versus oxytocin for the prevention of postpartum hemorrhage after elective caesarean section in high risk women: a prospective, randomized, open-label, controlled trial in China
Background: To evaluate the efficacy and safety of carbetocin compared with oxytocin for prevention of postpartum hemorrhage (PPH) after elective cesarean section in Chinese high risk women. Methods: This was a single-center, prospective, randomized, open-label, controlled trial recruiting 852 pregnant women with one or more PPH risk factors between April 2017 and August 2019. Pregnant woman who was scheduled for an elective cesarean section were randomly assigned to receive carbetocin or oxytocin for prevention of PPH. The primary efficacy endpoint was the proportion of additional uterotonics. Results: A total of 852 pregnant women were randomly assigned to receive carbetocin (n = 442) or oxytocin (n = 410). The baseline characteristics were comparable between the two groups. The carbetocin group had lower proportion of requiring additional uterotonics (18.4% vs. 24.4%, p = 0.03 in full analysis set [FAS] analysis) to the oxytocin group. The amount of blood loss (intrapartum or postpartum) was no statistically significant difference (all p > 0.05). There were no significant differences in the postpartum hemoglobin, rate of hemostatics, blood transfusion, additional surgical interventions or uterine massage between the two groups. The rates of mild asphyxia in carbetocin and oxytocin groups were 2.1% and 1.3%, respectively. No other poor maternal and neonatal outcomes were observed in two groups. Conclusions: Carbetocin required lower rate of additional uterotonics than oxytocin for prevention of PPH after elective cesarean section in Chinese high risk women. Carbetocin was comparable to oxytocin in postpartum blood loss, postpartum hemoglobin, hemostatics, blood transfusion, additional surgical interventions or uterine massage.
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来源期刊
CiteScore
0.50
自引率
0.00%
发文量
241
审稿时长
1 months
期刊介绍: CEOG is an international, peer-reviewed, open access journal. CEOG covers all aspects of Obstetrics and Gynecology, including obstetrics, prenatal diagnosis, maternal-fetal medicine, perinatology, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine, infertility, reproductive endocrinology, sexual medicine. All submissions of cutting-edge advances of medical research in the area of women''s health worldwide are encouraged.
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