Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 主要终点
- Complete abortion
研究概览
简要总结
this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.
详细描述
Intervention type: drug
Intervention name: letrozole then misoprostol
Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion
Arm group label:study group
Intervention type :drug
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
participant- care provider -investigator- outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Maternal age more than 18 years old.
- •Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
- •Hemoglobin >10 g/dl
- •Missed abortion
排除标准
- •Mullerian Uterine anomalies as septate, bicornuate uterus.
- •Fibroid uterus.
- •Coagulopathy.
- •Medical disorder that contraindicate induction of abortion.
- •Allergy to misoprostol or letrozole.
研究组 & 干预措施
letrozole then misoprostol
description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed
干预措施: letrozole (Drug)
placebo then misoprostol
Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed
干预措施: placebo (Drug)
结局指标
主要结局
Complete abortion
时间窗: 6 hours
incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol
次要结局
- surgical evacuation(6 hours)
研究者
Shereen Rady Abou El-fetouh
principal investigator
Ain Shams University