跳至主要内容
临床试验/CTRI/2024/10/075454
CTRI/2024/10/075454招募中Unknown

COMPARISON OF INTRACERVICAL FOLEY CATHETER WITH DINOPROSTONE GEL COADMINISTRATION VERSUS INTRACERVICAL DINOPROSTONE GEL ALONE FOR INDUCTION OF LABOUR IN AN OPEN LABEL RANDONMISED CONTROLTRIAL

DR MHALO1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年10月19日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
124
试验地点
1
主要终点
- To compare the Induction to Delivery interval (IDI), that is the time from first intervention to time of vaginal delivery among the two groups

研究概览

简要总结

We expect to establish the superiority of a combination of intracervical Foley catheter with Dinoprostone gel as compared to Dinoprostone gel for induction of labour. As this addition to the induction protocol is a cheap and readily available, we aim to increase rates of successful induction and decrease Caesarean rates with the help of the findings of this study.

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
20.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Nulliparous women with Bishop 6 or less on admission.
  • Term pregnancy (37-42 weeks).
  • Singleton fetus with cephalic presentation.
  • Reactive Non stress test at time of admission.
  • Intact bag of membranes.

排除标准

  • 未提供

结局指标

主要结局

- To compare the Induction to Delivery interval (IDI), that is the time from first intervention to time of vaginal delivery among the two groups

时间窗: 24 HOURS | DOSE OF DINOPROSTONE GEL-0.5 MG (TOTAL DOSE -1.5 MG)

次要结局

  • 1. Change in Modified Bishop score over 8 hours ,16 hours and 24 hours(2. To compare the time taken to reach from induction to active phase of labour (≥5cm cervical dilatation) in women between the two groups.)

研究者

发起方
DR MHALO
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

PREETI PRIYADARSHANI

AIIMS GORAKHPUR UP

研究点 (1)

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