A Prospective Double-Blind, Randomized, Placebo-Controlled Trial on the Use of Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Duration of induction of abortion
研究概览
简要总结
To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.
详细描述
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.
Patients fulfilling inclusion and exclusion criteria will be divided into two groups.
Group (A):
181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Group (B):
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
- Triple (Participant, Care Provider, Investigator)
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
- •Maternal age more than 18 years old (age of legal consent).
- •Gestational age between 12 weeks and 24 weeks.
- •Hemoglobin >10 g/dL.
- •BMI between 25 kg/m2 and 35 kg/m
- •Miscarriage .
- •Living fetus with multiple congenital malformations incompatible with life.
- •PPROMs with drained liquor and parents are consenting for termination of pregnancy.
排除标准
- •Maternal age less than 18 years old.
- •Gestational age less than 12 weeks or more than 24 weeks.
- •Hemoglobin <10 g/dL.
- •Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
- •Polyhydraminos.
- •Anencephaly.
- •Fibroid uterus.
- •BMI less than 25kg/m2 and more than 35kg/m
- •Coagulopathy.
- •History or evidence of adrenal pathology.
- •Previous attempts for induction of abortion in the current pregnancy.
研究组 & 干预措施
letrozole + misoprostol
Women will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.
干预措施: Letrozole (Drug)
letrozole + misoprostol
Women will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.
干预措施: Misoprostol (Drug)
placebo + misoprostol
Women will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.
干预措施: Placebo (Drug)
placebo + misoprostol
Women will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Duration of induction of abortion
时间窗: 24 hours
次要结局
- The incidence of need for surgical evacuation of placenta.(24 hours)
- Hemoglobin change(24 hours)
- Maternal morbidity(24 hours)
- Success of induction of abortion(24 hours)
- Hematocrit change(24 hours)
研究者
Mohamed S Sweed, MD
Mohamed Samir Sweed
Ain Shams University