Letrozole Plus Misoprostol Versus Misoprostol Alone in Induction of Abortion of Anembryonic Pregnancy:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Complete abortion
研究概览
简要总结
Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.
详细描述
Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •first trimester of pregnancy
- •pregnancy duration less than 12 weeks based on LMP.
- •non-viable fetus (blighted ovum)
排除标准
- •No heart disease,
- •No asthma
- •No History of thromboembolism
- •No History of cancer
- •No renal failure
- •No liver diseases
- •History of allergy to misoprostol or letrozole drugs.
研究组 & 干预措施
single dose letrozole tablets
starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.
干预措施: Letrozole tablets (Drug)
single dose letrozole tablets
starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.
干预措施: Misoprostol Tabets (Drug)
single dose letrozole tablets
starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.
干预措施: Placebo tablets (Drug)
multiple dose letrozole tablets
starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
干预措施: Letrozole tablets (Drug)
multiple dose letrozole tablets
starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
干预措施: Misoprostol Tabets (Drug)
misoprostol tablets
starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
干预措施: Misoprostol Tabets (Drug)
misoprostol tablets
starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Complete abortion
时间窗: 2 days
no emergency or elective curettage was necessary until next menstruation
次要结局
- Induction-to-abortion interval(2 days)
- Adverse effects of Misoprostol(2 days)
- Adverse effects of Letrozole(2 days)
研究者
Marwa Mohamed Abdalla
Clinical professor of Obstetrics and Gynecology
Cairo University