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临床试验/NCT05246761
NCT05246761招募中不适用

To Study the Effectiveness and Safety of Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section: Multicenter, Prospective, Observational Study

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 924 人开始时间: 2022年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
924
试验地点
1
主要终点
vignial birth rate

研究概览

简要总结

This study is a multi-center, prospective, observational clinical trial study. 924 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the prior cesarean section group, pregnant women with one previous cesarean section who are willing to try to the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the control group, pregnant women after 39 weeks of gestation without vaginal labor contraindications will be enrolled. Whether in the experimental group or the control group, their cervical bishop score was less than 6 points, and they all will be induced by balloon catheter + oxytocin. 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
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Volunteers sign the informed consent;
  • Age: 20-40 years;
  • Singleton, a cephalic presentation;
  • No contradiction to vaginal delivery; 5.39~42 weeks.
  • Exclusion criteria:
  • Konwn contraindication to vaginal delivery or severe complications;
  • Multiple gestation;
  • Uterine malformation;
  • Severe psychiatric disorder;
  • Without family's support.

排除标准

  • 未提供

结局指标

主要结局

vignial birth rate

时间窗: up to 84 hours

After the treatment of balloon catheter for 12 hours +oxytocin induction for up tp 72 hours, 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

研究点 (1)

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