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临床试验/CTRI/2024/05/067927
CTRI/2024/05/067927尚未招募4 期

A randomised control study to assess the safety and efficacy of oral misoprostol versus intracervical dinoprostone gel in induction of labour

Dr Suvetha Shree1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年6月5日最近更新:
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试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Assessment of mode of delivery-Normal vaginal delivery or LSCS
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  • PRIMARY OBJECTIVE:
  • To compare safety and efficacy of oral misoprostol (25 microgram) with      intracervical dinoprostone gel (0.5 mg) for cervical ripening and induction of labour
  • SECONDARY OBJECTIVE:
    1. To compare change in bishop score.
    1. To compare mode of delivery.
    1. To compare the need for augmentation of labour in active phase.
    1. To compare side effects and neonatal outcome.
    1. To compare the cost effectiveness of both.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)（—）
性别
Female

入选标准

  • •Post dated pregnancy, singleton pregnancy, vertex presentation, other indications of induction like GDM,GHTN,FGR.

排除标准

  • •Multiple gestation, preterm, non vertex presentation, previous LSCS, cephalopelvic disproportion.

结局指标

主要结局

Assessment of mode of delivery-Normal vaginal delivery or LSCS

时间窗: Induction to delivery interval

次要结局

  • Perinatal complications, neonatal complications(Up to 3 days after delivery)

研究者

发起方
Dr Suvetha Shree
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Suvetha Shree

ACS Medical college and hospital

研究点 (1)

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