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临床试验/CTRI/2011/10/002043
CTRI/2011/10/002043已完成不适用

ORAL MICRONIZED PROGESTERONE FOR MAINTENANCE TOCOLYSIS AFTER ARRESTED PRETERM LABOUR- A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年2月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
prolongation of pregnancy

研究概览

简要总结

The study is a randomized double blind placebo controlled trial  which aims to evaluate the efficacy of maintenance therapy with oral micronized progesterone for prolongation of pregnancy in cases of arrested preterm labour.The study is being conducted at GTB hospital and UCMS  delhi.The primary outcome is prolongation of pregnancy

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
19.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • .Only those Pregnant women between 24-34 weeks period of gestation with preterm labour pain .Singleton pregnancy .Intact membrane.

排除标准

  • .Multiple pregnancy .Premature rupture of membranes .Antepartum hemorrhage .Fetal growth restriction/gross congenital anomalies .Severe maternal illness.

结局指标

主要结局

prolongation of pregnancy

时间窗: NIL

次要结局

  • readmission for preterm labour(NIL)
  • number of pretem birth(nil)
  • birth weight(nil)
  • NICU admission rate(nil)
  • neonatal morbidity(nil)
  • early neonatal mortality(nil)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college

研究点 (1)

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