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临床试验/CTRI/2025/07/091976
CTRI/2025/07/091976尚未招募3 期

Comparison of Safety, Efficacy and Fetomaternal Outcome following Induction of Labour With Vaginal Misoprostol v/s Dinoprostone Gel in Primigravida: A Randomized Controlled Trial

Academic Clinical Trial1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
induction to delivey interval, change in Bishop score

研究概览

简要总结

This randomized controlled study aims to compare the safety, efficacy, and fetomaternal outcomes of two pharmacological agents namely vaginal misoprostol and intracervical dinoprostone gel, for the induction of labor in primigravida women. Conducted at Mathura Das Mathur Hospital, Jodhpur, under the Department of Obstetrics and Gynaecology, the study includes 50 term primigravida patients divided equally into two groups. Group A will receive 25 µg misoprostol intravaginally every 4 hours (maximum 2 doses), while Group B will receive 0.5 mg dinoprostone gel intracervically every 6 hours (maximum 2 doses). The study evaluates key parameters such as induction-to-delivery interval, Bishop score changes, requirement for oxytocin, mode of delivery, maternal and neonatal complications, Apgar score, and overall success or failure of labor induction. Data will be analyzed using SPSS software, with a p-value of <0.05 considered statistically significant. Ethical approval and informed consent procedures are in place to ensure patient safety and confidentiality. Previous literature supports misoprostol as a cost-effective, stable alternative with faster labor outcomes, although with higher risks of uterine hyperstimulation. This study seeks to provide localized, evidence-based recommendations for labor induction practices in resource-limited settings.

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 30.00 Year(s)(—)
性别
Female

入选标准

  • primigravida, term pregnancy, live fetus, bishop score less than equal to 5.

排除标准

  • multifetal pregnancy, malpresentation, abnormal fetal heart rate pattern, CPD, previous uterine surgery, placenta previa.

结局指标

主要结局

induction to delivey interval, change in Bishop score

时间窗: Hourly till delivery

次要结局

  • requirement of oxycotcin augmentation(6 hours)

研究者

发起方
Academic Clinical Trial
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr R K Deora

DR SN MEDICAL COLLEGE

研究点 (1)

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