Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- complete abortion rate
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
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
- 否
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.
- •Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
研究组 & 干预措施
study group
2 tablets of Letrozole 2.5 mg will be given as single daily doses, 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 three doses.
干预措施: Letrozole then misoprostol (Drug)
control group
2 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 three doses
干预措施: placebo then misoprostol (Drug)
结局指标
主要结局
complete abortion rate
时间窗: 9 hours
Incidence of complete miscarriage
time from induction to abortion
时间窗: 9 hours
induction to abortion time interval
次要结局
- Need for surgical evacuation of the products of conception(9 hours)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University