Comparison of Spontaneous Onset of Labor and Vaginal Delivery in Post-date Primigravida Undergoing Sweeping of Membranes Versus Expectant Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Spontaneous onset of labor and vaginal delivery
研究概览
简要总结
The study is planned to fill the gaps regarding the effectiveness of sweeping of membranes versus expectant management in terms of spontaneous onset of labor and vaginal delivery in post-date primigravida.
详细描述
This study is important as it provides localized data on the effectiveness and practicality of membrane sweeping in a low-resource setting, which is underrepresented in current literature. Potential benefits of this research may include reduced need for formal labor induction, lower healthcare costs, and improved maternal and neonatal outcomes. The findings may enhance clinical practices by offering an evidence-based, patient-friendly approach to managing postdate pregnancies, particularly in resource-limited settings where induction facilities are constrained.
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
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primigravid women
- •Aged between 18 and 40 years
- •Gestational age ≥40 weeks, confirmed by ultrasound or early dating scan
- •Singleton pregnancies
- •Cephalic presentation
排除标准
- •Multiple gestations
- •Fetal distress or anomalies detected on ultrasound
- •Contraindications to vaginal delivery (e.g., placenta previa, previous uterine surgery)
- •Previous uterine scar
研究组 & 干预措施
Membrane sweeping group
Participants in the membranes sweeping group will receive membrane sweeping. If labor will not initiate within 48 hours, the procedure will be repeated up to a maximum of three times at 48-hour intervals.
干预措施: Membrane sweeping (Procedure)
Expectant management group
Women in the expectant management group will receive no mechanical intervention, and these women will be monitored according to the standard protocol until spontaneous labor onset or labor induction will be deemed necessary.
结局指标
主要结局
Spontaneous onset of labor and vaginal delivery
时间窗: 6 days
The occurrence of regular uterine contractions (contractions occurring every 3-5 minutes, each lasting 30-60 seconds, and progressively increasing in intensity) leading to cervical changes without any form of labor induction will mark the achievement of spontaneous onset of labor.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research