Comparison of Letrozole With Misoprostol Versus Misoprostol Alone in the Management of Missed Miscarriages
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Complete abortion
研究概览
简要总结
The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally).
The main questions this study aims to answer are:
- Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
- Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage.
ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.
What Will Happen in the Study A total of 92 women will take part.
Participants will be randomly assigned to one of two groups:
Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.
Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.
Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.
Products of conception will be examined to confirm abortion.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound
- •Single intrauterine pregnancy
- •Planned for termination due to missed miscarriage
排除标准
- •Previous history of cesarean section
- •Uterine scar due to previous procedure like myomectomy
研究组 & 干预措施
Misoprostol with placebo
Vaginal Misoprostol will be instituted after oral placebo
干预措施: Misoprostol (given vaginally) (Drug)
Misoprostol with placebo
Vaginal Misoprostol will be instituted after oral placebo
干预措施: Placebo (Drug)
Misoprostol with Letrozole
After oral letrozole, vaginal Misoprostol will be instituted
干预措施: Misoprostol (given vaginally) (Drug)
Misoprostol with Letrozole
After oral letrozole, vaginal Misoprostol will be instituted
干预措施: Letrozole 5 mg (Drug)
结局指标
主要结局
Complete abortion
时间窗: From start of study medication after randomization to within 24-hours
The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound.
次要结局
未报告次要终点
研究者
Afrayshum Tariq
Principal Investigator
Nishtar Medical University