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临床试验/NCT07261332
NCT07261332已完成不适用

A Comparative Study on Early Versus Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes at Term

Laiba Qamar1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年5月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Duration of labour

研究概览

简要总结

To compare the effects of early V/s delayed induction of labour and its outcomes in patients presenting with PROM without labour.

详细描述

This is a comparative study where the patient who presented with PROM were assigned 2 groups of intervention . One had early induction of labour and other had induction of labour after 24 hours of observation. Both groups were compared for the average time of labour till delivery of the fetus and the frequency of spontaneous vaginal delivery was also calculated for each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy with cephalic presentation
  • gestational age between 37-41 weeks as calculated by last menstrual period date or early dating ultrasoumd
  • Spontaeous PROM as confirmed by history and sterile speculum examination
  • modified bishop score <6
  • no detectable uterine contractions on admission
  • clear liqour and duration of PROM <6 hours at admission

排除标准

  • meconium stained liqour
  • patients with features of chorioamnionitis (fever , tachycardia, abdominal tendernessor foul smeeling vaginal discharge
  • maternal medical diseaseincluding prompt delivery or C section like severe preeeclampsia, renal or cardiac disease
  • presence of contraindications to labour such as placenta previa , Vasa previa,previous uterine surgery (e.g myomectomy ) that increases the risk of uterine rupture , previous C section
  • history of antepartum hemorrhage
  • Moderate to severe IUGR as diagnosed on ultrasound and doppler studies

研究组 & 干预措施

early induction of labour for PROM

Experimental

The patients assigned with this arm when presented with PROM were inducted immidiately for labour and no observation was done for 24 hours for spontaneous induction of labour

干预措施: 0.5mg PGE2 gel (Drug)

Late induction of Labour in PROM

Active Comparator

The patients assigned with this arm were observed for 24 hours for any spontanous induction of labour and then only proceeded with manual induction.

干预措施: 0.5mg PGE2 gel (Drug)

结局指标

主要结局

Duration of labour

时间窗: 24 hours

the duration of labour was assesed after each method of induction when patients presented with PROM

次要结局

  • Frequency of Normal Vaginal Delivery(24 hours)

研究者

发起方
Laiba Qamar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Laiba Qamar

Supervisor

University of Health Sciences Lahore

研究点 (1)

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