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一项通过引入剖宫产术后试产和电子宫描记术来降低中国剖宫产率的随机对照试验。

A randomized controlled trial reducing cesarean delivery rates in China by introducing trial of labor after cesarean and electrohysterography.

机构信息

Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.

Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.

出版信息

J Matern Fetal Neonatal Med. 2024 Dec;37(1):2376661. doi: 10.1080/14767058.2024.2376661. Epub 2024 Jul 14.

DOI:10.1080/14767058.2024.2376661
PMID:39004516
Abstract

OBJECTIVE

A cesarean delivery (CD) can affect health of both mother and child and future pregnancies. Since the abandonment of the one-child policy in China, obstetricians tend to perform a repeat CD rather than a trial of labor after cesarean (TOLAC). This study aims to reduce CD rates by increasing vaginal births after cesarean (VBAC) rates and introducing electrohysterography (EHG) for accurate monitoring.

METHODS

In total, 82 women received counseling regarding TOLAC at the Shijiazhuang Sixth Hospital in China. Women opting for TOLAC were randomized for either external tocodynamometry (TOCO, i.e. standard care) or EHG. The primary outcome was the VBAC rate. Secondary outcomes were indications for CD, percentage of assisted vaginal deliveries, labor duration, maternal blood loss, complications and neonatal outcomes.

RESULTS

After accounting for preterm delivery and dropouts, all counseled women opted for a TOLAC (100%). After randomization, 42 women were included in the TOCO-group and 37 in the EHG-group. Women did not receive pain medication and labor was not augmented with oxytocin. The VBAC rate was 71.4% in the TOCO-group, versus 78.4% in the EHG-group ( = .48). Birth was assisted with forceps in 11.9% of TOCO-group versus 2.7% of EHG-group ( = .21). One secondary CD (i.e. a shift from intended vaginal delivery to surgical delivery within the same labor) was performed because of a suspicion of uterine rupture (TOCO-group). Other indications for CD were: fetal distress, labor dystocia, fetal position, cephalopelvic disproportion. There were no significant differences in secondary study outcomes. No complications were reported.

CONCLUSION

This study showed an average VBAC rate of 75%, without any complications, in a hospital with no previous experience with TOLAC. The VBAC rate with EHG-monitoring was higher than TOCO, although this difference was not significant. To demonstrate a significant difference, larger clinical studies are necessary.

TRIAL REGISTRATION

The Daily Board of the Medical Ethics Committee of The Maternal and Child Hospital of Shijiazhuang approved the study protocol (number 20171018, Dutch Trial Register NL8199).

摘要

目的

剖宫产(CD)会影响母婴健康和未来妊娠。自中国放弃独生子女政策以来,产科医生倾向于进行重复剖宫产,而不是剖宫产后试产(TOLAC)。本研究旨在通过提高剖宫产后阴道分娩(VBAC)率并引入电子宫描记术(EHG)进行准确监测来降低剖宫产率。

方法

在中国石家庄市第六医院,共有 82 名妇女接受了 TOLAC 咨询。选择 TOLAC 的妇女随机分为外部胎儿宫缩计(TOCO,即标准护理)或 EHG。主要结局是 VBAC 率。次要结局为剖宫产指征、辅助阴道分娩率、产程、产妇出血量、并发症和新生儿结局。

结果

考虑到早产和脱落,所有接受咨询的妇女均选择 TOLAC(100%)。随机分组后,42 名妇女进入 TOCO 组,37 名妇女进入 EHG 组。妇女未接受止痛药物,也未使用催产素增强产力。TOCO 组 VBAC 率为 71.4%,EHG 组为 78.4%( = .48)。TOCO 组 11.9%的分娩需要产钳辅助,EHG 组为 2.7%( = .21)。由于怀疑子宫破裂(TOCO 组),进行了 1 例二次剖宫产(即在同一产程中从计划阴道分娩转为手术分娩)。其他剖宫产指征为:胎儿窘迫、产程延长、胎儿位置异常、头盆不称。次要研究结局无显著差异。无并发症报告。

结论

本研究在一家以前没有 TOLAC 经验的医院中,显示平均 VBAC 率为 75%,无任何并发症。EHG 监测的 VBAC 率高于 TOCO,但差异无统计学意义。为了证明显著差异,需要进行更大规模的临床研究。

试验注册

石家庄市妇幼保健院医学伦理委员会日常委员会批准了该研究方案(编号 20171018,荷兰临床试验注册 NL8199)。

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