Comparison of Safety, Efficacy and Fetomaternal Outcome following Induction of Labour With Vaginal Misoprostol v/s Dinoprostone Gel in Primigravida: A Randomized Controlled Trial
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
Dr R K Deora
DR SN MEDICAL COLLEGE
