Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of complete miscarriage
研究概览
简要总结
This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
详细描述
According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period
Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week
letrozole administration with misoprostol raises the rate of complete abortion
Hypothesis
In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age less than 64 days gestation (<9 wks).
- •Hemoglobin >10 g/dL.
- •BMI between 18.5 kg/m2 and 25 kg/m
- •Missed abortion.
排除标准
- •Molar pregnancy.
- •Fibroid uterus.
- •Uterine anomalies.
- •Coagulopathy.
- •Medical disorder that contraindicate induction of abortion (e.g. heart failure).
- •Previous attempts for induction of abortion in the current pregnancy.
- •Allergy to misoprostol or letrozole.
研究组 & 干预措施
Study group
3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
干预措施: Letrozole 2.5mg (Drug)
Study group
3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
干预措施: Misoprostol (Drug)
Control group
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
干预措施: Placebo (Drug)
Control group
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
干预措施: Misoprostol (Drug)
结局指标
主要结局
Incidence of complete miscarriage
时间窗: 6 hours
次要结局
- Need for surgical evacuation of the products of conception(6 hours)
- Incidence of Septic Abortion(1 week)
研究者
Dr- dina yahia mansour
Lecturer of Obstetrics and Gynecology Ain Shams University
Ain Shams Maternity Hospital