COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Expulsion of product of conception
研究概览
简要总结
Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mifepristone
Participants with 1st trimester miscarriage will receive oral 200mg mifepristone .
After 48 hours of mifepristone, 800 micro gm misoprostol will be given vaginally for expulsion of product of conception (standard care).
干预措施: Mifepristone (Drug)
Letrozole
Participants with 1st trimester miscarriage will receive 10mg letrozole orally for three consecutive days.
This is to be followed by tablet misoprostol 800 micro gm vaginally for expulsion of product of conception (standard care).
干预措施: Letrozole (Drug)
结局指标
主要结局
Expulsion of product of conception
时间窗: 24 hours since administration of misoprostol
Mean duration of expulsion since administration of vaginal misoprostol
Requirement of surgical evacuation
时间窗: beyond 24 hours since misoprostol administration
Surgical evacuation where complete abortion does not occur
次要结局
未报告次要终点
研究者
Dr.Jhuma Biswas
Associate Professor, Dept. of Obstetrics and Gynecology, Calcutta National Medical College and Hospital
Calcutta National Medical College and Hospital