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临床试验/NCT05197101
NCT05197101Unknown不适用

To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation: a Randomized, Controlled, Observational Study

The First Affiliated Hospital with Nanjing Medical University0 个研究点目标入组 150 人开始时间: 2022年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
主要终点
vaginal birth rate

研究概览

简要总结

This study is a randomized, controlled, observational study. 150 nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation will be enrolled as subjects in the two groups is 1:1. In the experimental group, vaginal examination will be performed at 39 to 40 weeks to assess cervical conditions. If the bishop score <6, the balloon catheter combined with oxytocin induction will be planned at 40 weeks ±3 days. In the control group, one week to 41 weeks ±3 days will be expected. Vaginal examination will be performed again to evaluate cervical conditions. If the bishop score <6 points, and balloon catheter combined with oxytocin induction will be performed. After 96h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •singleton head position pregnancy, negative Down's screening and /or NIPT screening, no malformation was found, with slight/without pregnancy complications -

排除标准

  • •twin or multiple pregnancy, scar uterus, with contraindications to vaginal delivery, estimated fetal weight >4500g

研究组 & 干预措施

nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation

Experimental

干预措施: balloon catheter combined with oxytocin induction (Procedure)

结局指标

主要结局

vaginal birth rate

时间窗: 24 hours

After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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