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缩宫素给药途径对延迟断脐新生儿血红蛋白的影响:一项多中心随机对照临床试验。

Effect of administration routes of oxytocin on hemoglobin in neonates with delayed umbilical cord clamping: a multi-centre randomized controlled clinical trial.

机构信息

Department of Obstetrics and Gynaecology, Nanjing Drum Tower Hospital, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, 210008, China.

Department of Obstetrics and Gynaecology, Nanjing Jiangning Hospital of Chinese Medicine, Nanjing, 211100, China.

出版信息

Arch Gynecol Obstet. 2024 Aug;310(2):991-999. doi: 10.1007/s00404-024-07543-w. Epub 2024 May 16.

Abstract

PURPOSE

To evaluate the effect of intravenous infusion versus intramyometrial injection of oxytocin on hemoglobin levels in neonates with delayed umbilical cord clamping during cesarean section.

METHODS

The multi-centre randomized controlled trial was performed at three hospitals from February to June 2023. Women with term singleton gestations scheduled for cesarean delivery were allocated to receive an intravenous infusion of 10 units of oxytocin or a myometrial injection of 10 units of oxytocin during the surgery. The primary outcome was neonatal hemoglobin at 48 to 96 h after birth. Secondary outcomes were side-effects of oxytocin, postpartum haemorrhage, phototherapy for jaundice, feeding at 1 month, maternal and neonatal morbidity and re-admissions.

RESULTS

A total of 360 women were randomized (180 women in each group). The mean neonatal hemoglobin did not show a significant difference between the intravenous infusion group (194.3 ± 21.7 g/L) and the intramyometrial groups (195.2 ± 24.3 g/L) (p = 0.715). Secondary neonatal outcomes, involving phototherapy for jaundice, feeding at 1 month and neonatal intensive care unit admission were similar between the two groups. The maternal outcomes did not differ significantly between the two groups, except for a 200 mL higher intraoperative infusion volume observed in the intravenous group compared to the intramyometrial group.

CONCLUSION

Among women undergoing elective cesarean delivery of term singleton pregnancies, there was no significant difference in neonatal hemoglobin at 48 to 96 h after birth between infants with delayed cord clamping, whether the oxytocin was administrated by intravenous infusion or intramyometrial injection.

TRIAL REGISTRATION

Chinese Clinical trial registry: ChiCTR2300067953 (1 February 2023).

摘要

目的

评估剖宫产术中延迟断脐时静脉输注与子宫肌内注射催产素对新生儿血红蛋白水平的影响。

方法

多中心随机对照试验于 2023 年 2 月至 6 月在 3 家医院进行。将具有足月单胎妊娠且计划行剖宫产的产妇随机分配,在手术期间接受 10 单位催产素静脉输注或子宫肌内注射 10 单位催产素。主要结局为出生后 48 至 96 小时新生儿血红蛋白。次要结局为催产素的副作用、产后出血、黄疸的光疗、1 个月时喂养、母婴发病率和再入院。

结果

共随机分配 360 名产妇(每组 180 名)。静脉输注组(194.3±21.7 g/L)与子宫肌内组(195.2±24.3 g/L)新生儿血红蛋白平均值无显著差异(p=0.715)。两组间涉及黄疸光疗、1 个月时喂养和新生儿重症监护病房入院等次要新生儿结局相似。两组产妇结局无显著差异,除静脉组术中输注量比子宫肌内组高 200 mL 外。

结论

在择期行剖宫产的足月单胎妊娠产妇中,延迟断脐时,催产素通过静脉输注或子宫肌内注射给药,新生儿出生后 48 至 96 小时的血红蛋白无显著差异。

试验注册

中国临床试验注册中心:ChiCTR2300067953(2023 年 2 月 1 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a414/11258157/4f0835a35e10/404_2024_7543_Fig1_HTML.jpg

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