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临床试验/CTRI/2019/01/017054
CTRI/2019/01/017054已完成不适用

Our initial experience with Atosiban for preterm labour in a tertiary care centre

Army Research and Referral Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月14日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Proportion of patients who will be undelivered upto 72 hours after completion of treatment phase and those not delivered till the end of 7 days

研究概览

简要总结

Objectives:

To sudy the efficacy of atosiban in established cases of preterm labour

Validity of better symptomatic results and better fetal outcome after the treatment with inj. Atosiban

Study design: Prospective clinical trial

Inclusion criteria:

All patients with preterm labour singleton / multifetal gestation beyond 24 weeks of gestation to 33 weeks + 06 days with intact amniotic membranes

Exclusion criteria:

All patients with preterm rupture of membranes

All patients of abruptio placenta

All patients less than 24 weeks of gestation

All patients more than 34 weeks of gestation

All patients with fever, tachycardia and positive CRP in maternal blood on admission

All patients with IUD/congenital anomaly

Patients needing more than one tocolytic agent

Outcome measures:

Primary outcome:. The primary  outcome will be undelivered up to 72 hrs after completion of treatment phase and those not delivered till the end of their hospital stay (upto 7 days).

Secondary outcomes:

Perinatal death

Mode of delivery

Emergency Cesarean (if any)

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

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

入选标准

  • All patients with preterm labour Singleton/ multi fetal gestation beyond 24weeks of gestation to 33 weeks + 6 days with intact amniotic membranes.

排除标准

  • All patients with preterm rupture of membranes
  • All patients of abruptio placenta
  • All patients less than 24 weeks of gestation
  • All patients with fever , tachycardia and positive CRP in maternal blood on admission
  • All patients with IUD /congenital anomaly 7.

结局指标

主要结局

Proportion of patients who will be undelivered upto 72 hours after completion of treatment phase and those not delivered till the end of 7 days

时间窗: Throughout study duration

次要结局

  • 1.Perinatal death.(2.Mode of delivery.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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