Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion: Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Incidence of complete abortion
研究概览
简要总结
The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
详细描述
Primary outcome:
Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol)
Secondary outcome:
Need for surgical evacuation of the products of conception
- Incomplete expulsion of the products of conception (incomplete miscarriage).
- Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity
- Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
- Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit
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 less than 13 weeks.
- •Hemoglobin >10 g/dL.
- •BMI between 25 kg/m2 and 35 kg/m
- •Missed abortion.
- •Living fetus with multiple congenital malformations incompatible with life.
排除标准
- •Maternal age less than 18 years old.
- •Gestational age more than 12 weeks.
- •Hemoglobin <10 g/dL.
- •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.
- •Allergy to misoprostol or letrozole.
- •Medical disorder that contraindicate induction of abortion (e.g. heart failure).
研究组 & 干预措施
letrozole
Women will receive three tablets of letrozole(FemaraR, NOVARTIS) 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 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
干预措施: Letrozole (Drug)
letrozole
Women will receive three tablets of letrozole(FemaraR, NOVARTIS) 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 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
干预措施: Misoprostol (Drug)
placebo
Women will receive three tablets of placebo as a single dose, 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 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
干预措施: Misoprostol (Drug)
placebo
Women will receive three tablets of placebo as a single dose, 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 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of complete abortion
时间窗: 1 week
complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol
次要结局
- Need for surgical evacuation of the products of conception(1 week)
- Hemoglobin and hematocrit deficit(1 week)
- Maternal morbidity(1 week)
研究者
Mohamed S Sweed, MD
Lecturer of obstetrics and gynaecology
Ain Shams University