The effect of mifepristone and misoprostol on termination of second trimester pregnancy with and without Letrozole: a placebo controlled randomized clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Complete expulsion (including fetus and placenta).
研究概览
简要总结
Second Trimester Medical termination of pregnancy are mainly done using a combination of misoprostol and mifepristone tablets. Although this combination is satisfactory, several women fail to expel the products of conception and require long hospital stay and multiple misoprostol dosages. Letrozole has been approved by WHO for first trimester pregnancy and has the potential to further improve the success rate of available misoprostol/mifepristone combination. In this RCT , the women in intervention arm will receive tablet Letrozole for 3 days along with standard misoprostol/mifepristone regimen. Women in control group will receive a placebo tablet in place of Letrozole along with standard misoprostol/mifepristone regimen.
The primary outcome is to compare complete uterine evacuation within 24h of starting Misoprostol tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •12 to 24 weeks MTP.
排除标准
- •Severe anemia, heart disease, bleeding disorders, Previous LSCS, liver or renal disorders, known allergy or contraindications to the study drugs (chronic systemic use of corticosteroids; chronic adrenal failure; current therapy with anticoagulants; or inherited porphyria) Low lying placenta, previous history of hysterotomy, Breast feeding, Intrauterine device in situ, multiple gestation and concurrent usage of any other ripening agent like cervical Foley’s catheter placement.
结局指标
主要结局
Complete expulsion (including fetus and placenta).
时间窗: 24 hours
次要结局
- To compare induction-abortion interval, hospital stay, misoprostol dosage, need for surgical evacuation, side effects and acceptability of the two regimen in women undergoing termination of second trimester pregnancy.(24 h after misoprostol adminstration,)
研究者
S Murali
Jawaharlal institute of postgraduate medical education and research