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临床试验/CTRI/2018/10/016154
CTRI/2018/10/016154已完成不适用

A randomized controlled trial comparing a 30-ml Foley catheter balloon without weight and a 30-ml Foley catheter balloon with 500gm weight [500ml of 5% DEXTROSE ] for preinduction cervical ripening for women with past dates requiring Induction of labour.

Christian Medical College1 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2018年1月11日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
398
试验地点
1
主要终点
Prevention of LSCS for failed induction

研究概览

简要总结

This is a prospective randomized controlled trial which will be done in pregnant women at term with no risk factors. Women in the arm randomized to induction with a foleys catheter will be induced with the foleys catheter inflated with 30 ml sterile water. The other group will be induced with foleys catheter inflated with 30 ml sterile water. The end of this foleys catheter will be attached to a 500 gm weight (500ml of 5% dextrose). These women will then be induced with oxytocin after 12 hours of inserting the foleys catheter if they do not have uterine contractions. After informed consent, women will be recruited from labour room and randomized to either of the groups. Data regarding duration of labour, fever, CTG abnormalities, neonatal morbidity etc., will be collected. The data will be analyzed to compare safety and efficacy in both groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Singleton pregnany 2.Primigravida and multigravida needing induction at 39 weeks and beyond 3.Cephalic presentation 4.Bishops score less than or equal to 4.

排除标准

  • 1.Previous LSCS 2.Previous endometritis 3.Any high risk factors requiring induction at <39 weeks.

结局指标

主要结局

Prevention of LSCS for failed induction

时间窗: Time from induction to vaginal delivery or Caesarean delivery

次要结局

  • 1. Effectiveness(2. Complications)

研究者

申办方类型
Private medical college

研究点 (1)

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