跳至主要内容
临床试验/CTRI/2025/08/092977
CTRI/2025/08/092977尚未招募不适用

A Randomised Controlled Trial Comparing Transcervical foleys catheter with vaginal misoprostol vs Vaginal misoprostol alone in Nulliparous Pregnant women at 40 weeks.

Dr Radhakrishnan Government Medical College1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年8月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
Induction delivery interval (defined as time of induction with foleys insertion and vaginal misoprostol to delivery of

研究概览

简要总结

Induction of labor (IOL) implies stimulation of uterine contractions before the spontaneous onset of labor, with or without ruptured membranes.It is an intervention designed for iatrogenic ripening of cervix and to initiate uterine contractions leading to progressive dilatation and effacement of cervix resulting into birth of the newborn. It is indicated only when the risks of continuing pregnancy outweigh the benefits to the mother and the fetus. The goal of IOL is to achieve vaginal delivery in a safe and timely manner. Methods of IOL presently in use include various mechanical, pharmacological or a combination of mechanical and pharmacological.  Mechanical methods include use of various agents such as transcervical foley’s catheter (TCFC), laminaria tents, synthetic osmotic dilators etc. TCFC is a cheap, readily available, easy to use and moreover a comparatively painless alternative which affects changes on various components of the bishop score.. TCFC works through mechanical dilation, resulting in the release of natural prostaglandins from the cervix.Pharmacological methods of IOL include agents such as oxytocin, prostaglandins (e.g. Misoprostol i.e. PGE1 and Dinoprostone i.e. PGE2), mifepristone etc.Prostaglandins ripen the cervix directly by enzymatic collagen degradation and increase of water content in the extracellular matrix. It effectively ripens the cervix and also induces uterine contractions. Its use can result in shorter induction-to-delivery times. The catheters have several potential advantages over pharmacologic methods. They are relatively inexpensive, easy to store, and easy to remove when necessary lacks systemic side effects, reversible and can be used in women with previous CS.

Hence, we plan to compare vaginal misoprostol alone vs TCFC with vaginal misoprostol as an adjunct for IOL in pregnant women at term.

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

  • Single live intrauterine fetus with cephalic presentation .
  • Period of gestation more than equal to 40 weeks.

排除标准

  • Modified Bishop score more than equal to 6
  • All contraindications to vaginal delivery .eg carcinoma cervix, structural pelvic abnormalities eg.
  • rachitic pelvis, Cephalopelvic disproportion.
  • Fetal malpresentations.
  • Previous uterine surgery .
  • Multifetal gestation.
  • Antepartum hemorrhage.
  • Intrauterine fetal demise.
  • Allergy to latex.
  • Active genital herpes.
  • Contraindications to prostaglandins .eg.
  • Asthma, cardiac disease, known bleeding disorder, concurrent anticoagulant therapy, pelvic infection, hypersensitivity.

结局指标

主要结局

Induction delivery interval (defined as time of induction with foleys insertion and vaginal misoprostol to delivery of

时间窗: From the time of insertion of transcervical foleys and misoprostol to delivery of foetus and will be assessed after delivery

fetus)

时间窗: From the time of insertion of transcervical foleys and misoprostol to delivery of foetus and will be assessed after delivery

次要结局

  • Proportion of woman delivered vaginally(Within 12 to 24 hours of induction)
  • Proportion of woman undergoing CS(After delivery)
  • Meconium stained liquor(Not Applicable)
  • Proportion of woman with Failed IOL(Neonatal Outcome)

研究者

发起方
Dr Radhakrishnan Government Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Arzoo

Dr.Radhakrishnan Medical College

研究点 (1)

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