CTRI/2025/12/098372尚未招募2/3 期
Comparison of standard and high dose mifepristone regimen for labour induction after foetal demise
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Induction delivery interval
研究概览
简要总结
This pilot randomized controlled trial aims to evaluate whether a high-dose mifepristone regimen is more effective than the standard dose for induction of labor in cases of intrauterine fetal demise. The study assesses the impact of increasing mifepristone dose on reducing the induction to delivery interval, lowering the total misoprostol requirement, and improving the rate of successful vaginal delivery. The trial also examines whether high-dose mifepristone can minimize misoprostol-related adverse effects, thereby enhancing the overall safety and effectiveness of the induction process.
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 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton pregnancy Confirmed IUFD of 28 weeks or more Longitudinal lie.
排除标准
- •Patient in whom mifepristone is contraindicated Unknown scar Previous 2 or more LSCS Low lying placenta History of myomectomy Medical surgical disorders.
结局指标
主要结局
Induction delivery interval
时间窗: Baseline,48 hours,72 hours
次要结局
- Number of successful vaginal delivery(48 hours)
- Reduction in requirement & total dosage of misoprostol used(72 hours)
研究者
Sanchita Jha
Post Graduate institute of medical education and research
研究点 (1)
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