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卡贝缩宫素与缩宫素预防产后出血的随机对照研究(CONCERT 试验)

A randomized controlled trial on the comparison of two doses of carbetocin with oxytocin for the prevention of postpartum hemorrhage (concert trial).

机构信息

Department of Obstetrics and Gynaecology, University College Hospital, Ibadan, Oyo, Nigeria.

Department of Obstetrics and Gynaecology, Faculty of Clinical Sciences, College of Medicine, University of Ibadan, Ibadan, Oyo, Nigeria.

出版信息

J Obstet Gynaecol Res. 2024 Nov;50(11):2046-2056. doi: 10.1111/jog.16097. Epub 2024 Oct 2.

DOI:10.1111/jog.16097
PMID:39359132
Abstract

AIM

To compare the effectiveness of 50 and 100 μg of carbetocin with 10 IU of oxytocin for the prevention of postpartum hemorrhage (PPH).

METHODS

This was a triple-blind, non-inferiority trial involving pregnant women recruited at term. We compared two doses of carbetocin (50 and 100 μg) with 10 IU of oxytocin administered as uterotonic agent after vaginal or cesarean delivery. Uterine contractility was assessed at 2- and 5-min after uterotonic administration. The association between adequate uterine tone and PPH with the patients' characteristics were examined using the chi-square test. Effect of the drugs on the odds of developing PPH was examined using logistics regressions. All analyses were conducted using STATA (StataCorp L.L.C.) with a significance level set at 0.05.

RESULTS

In total, 324 women (50 μg carbetocin group-111, 100 μg carbetocin group-106, and oxytocin group-107) participated in the study. There was a significantly higher proportion of women with adequate uterine tone in those that had 100 μg carbetocin relative to 50 μg and 10 IU oxytocin at 5 min (p < 0.001). Patients who received oxytocin had a higher average blood loss than women that had either 50 or 100 μg carbetocin (p = 0.128). There was a significant difference in the need for additional uterotonic, with a higher proportion of participants among those who received 10 IU of oxytocin (p < 0.001).

CONCLUSION

Patients that had 100 μg of carbetocin had a better adequate uterine tone at the fifth minute compared to those who had 50 μg and 10 IU of oxytocin. Generally, carbetocin use was less likely associated with risk of PPH and use of additional intervention.

摘要

目的

比较卡贝缩宫素 50μg 和 100μg 与缩宫素 10IU 预防产后出血(PPH)的效果。

方法

这是一项三盲、非劣效性试验,纳入足月妊娠孕妇。我们比较了两种剂量的卡贝缩宫素(50μg 和 100μg)与阴道或剖宫产分娩后作为子宫收缩剂给予的 10IU 缩宫素。在子宫收缩剂给药后 2 分钟和 5 分钟评估子宫收缩性。使用卡方检验检查子宫收缩良好与 PPH 与患者特征之间的关系。使用逻辑回归检查药物对发生 PPH 的可能性的影响。所有分析均使用 STATA(StataCorp L.L.C.)进行,显著性水平设为 0.05。

结果

共有 324 名妇女(50μg 卡贝缩宫素组 111 名,100μg 卡贝缩宫素组 106 名,缩宫素组 107 名)参与了这项研究。在 5 分钟时,与 50μg 卡贝缩宫素和 10IU 缩宫素相比,接受 100μg 卡贝缩宫素的女性中子宫收缩良好的比例明显更高(p<0.001)。接受缩宫素的患者平均出血量高于接受 50μg 或 100μg 卡贝缩宫素的患者(p=0.128)。需要额外使用子宫收缩剂的患者之间存在显著差异,其中接受 10IU 缩宫素的患者比例更高(p<0.001)。

结论

与接受 50μg 卡贝缩宫素和 10IU 缩宫素的患者相比,接受 100μg 卡贝缩宫素的患者在第五分钟时子宫收缩良好的比例更高。总体而言,卡贝缩宫素的使用与 PPH 风险和额外干预的使用的相关性较低。

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