Termination of Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- · Complete abortion rate.
研究概览
简要总结
Termination of Second trimester Abortion with Letrozole and Misoprostol Compared to Misoprostol Alone
详细描述
An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:
- Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol.
- Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment.
This study will be open-label due to different drugs and route of administrations used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 18-45 years.
- •Failed pregnancy.
- •Gestational age between 14 and 20weeks, confirmed by ultrasonography on the day of admission.
- •Hemoglobin concentration >9 g/dL.
- •Closed cervix.
- •Absence of products of conception in the cervical canal.
排除标准
- •Previous attempt to terminate the current pregnancy.
- •Molar pregnancy (hydatidiform mole).
- •Pathological uterine lesions including uterine fibroids and congenital uterine malformations.
- •Cardiac disease.
- •Renal disease.
- •Hemorrhagic disorders.
- •Body mass index (BMI) >35 kg/m².
- •Documented hypersensitivity or allergy to letrozole, misoprostol, or any of the study medications.
研究组 & 干预措施
Group I (Letrozole + Misoprostol)
Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol
干预措施: · Misoprostol + letrozole (Drug)
Group II (Misoprostol alone
· Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment.
干预措施: misoprostol alone (Drug)
结局指标
主要结局
· Complete abortion rate.
时间窗: 1 weak
次要结局
未报告次要终点
研究者
Ahmed Khalifa Ahmed Elsayed
Ahmed Khalifa Ahmed
Sohag University