Study at Zagazig General Hospital
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Complete abortion
研究概览
简要总结
Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
详细描述
Aim of the Work
Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman age more than 18 years old (age of legal consent).
- •BMI ranges between 25 kg/m2 and 35 kg/m
- •Gestational age of 63 days' gestation (or less).
- •Missed abortion.
- •Hemoglobin leve
- •Exclusion criteria:
- •Woman age less than 18 years old.
- •BMI less than 25 kg/m2 or more than 35 kg/m
- •Gestational age more than 63 days' gestation.
- •Molar pregnancy.
- •Hemoglobin level less than 10 gm/dL.
- •Fibroid uterus.
- •Uterus with congenital anomalies.
- •Previous attempts for induction of abortion in the current pregnancy.
- •Coagulation defect i.e. coagulopathy.
- •Contraindication for induction of abortion e.g. heart failure.
- •Allergy to misoprostol or letrozole.
排除标准
- 未提供
研究组 & 干预措施
Letrozole misoprostol
Group (A):
A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start
干预措施: Letrozole misoprostol (Device)
Misoprostol,placebo
Group (B):
A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start
干预措施: Misoprostol, placebo (Drug)
结局指标
主要结局
Complete abortion
时间窗: 1week
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
次要结局
未报告次要终点
研究者
Dr.Dalia Mohammed Al Sayed Zaki
Banha university
Benha University