Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Miscarriage Achievement
研究概览
简要总结
Abortion is one of the most common complications of pregnancy. Missed abortion is a type of abortions, occurs in 15%-20% of clinically diagnosed pregnancies and is defined as the retention of pregnancy products in the uterus for several days or weeks after death of the fetus.
详细描述
Various medical and surgical methods have been used to manage missed abortions. Surgical methods include dilatation and curettage, and vacuum aspiration. Because these methods are expensive and involve anesthesia, however, medical methods are generally preferred over surgical methods for abortion.
Medical approaches include misoprostol which is a prostaglandin that causes myometrial contractions, cervical softening and dilatation. It is used to induce abortion and labor and to treat atonic postpartum hemorrhage and peptic ulcers.
It has the advantage of being cost-effective and stable with a low rate of side effects which has led to it being included in the World Health Organization list of essential medications (2014). Misoprostol is licensed for use to induce miscarriage in Egypt. It has not been licensed to induce labor or miscarriage in certain countries such as Germany, but it is used off-label to induce labor in the UK.
Usage of Misoprostol alone has a success rate of between 65 and 93% especially in the early stages of pregnancy. It can also use in combination with other medications such as mifepristone and methotrexate to increase the success rate.
Most studies have examined the effect of letrozole plus misoprostol on the abortion of live embryos .Given the significance of specifying an effective and safe method for termination of abortion and the specific features of letrozole, such as its safety, cost-effectiveness, and availability.
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
- 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
- •Missed or anembryonic pregnancy.
- •Gestational age from 4 weeks to 26 weeks of pregnancy (confirmed by ultrasound scanning on first day of admittance).
- •Hemoglobin level more than 9g/l.
- •Closed cervix.
- •No product of conception in the cervical canal.
排除标准
- •Previous attempt to terminate the pregnancy.
- •Molar pregnancy
- •Abnormal uterine lesions such as fibroids or congenital mal formations.
- •Pregnancy despite of intrauterine contraceptive device.
- •Medical disorders as cardiac, renal or hemorrhagic diseases.
- •BMI more than 35 kg/m
- •Known hypersensitivity to any of the medication used.
研究组 & 干预措施
Group A: letrozole and Misoprostol
About 35 pregnant women will receive aromatase inhibitor (letrozole) 2.5 mg tablet three times daily for 3 days followed by two doses of 400 micrograms of misoprostol administered vaginally on the 4th day of enrolment (two 200-μg tablets spaced 4 hours apart).
干预措施: Letrozole 2.5mg (Drug)
Group B: Misoprostol
About 35 pregnant women will receive two doses of 400 µg of vaginal misoprostol (two 200-μg tablets spaced 4 hours apart).
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
Miscarriage Achievement
时间窗: 10 days
The induction-to-abortion interval in each group
次要结局
未报告次要终点
研究者
Arwa Ashraf Saeed
Demonstrator at Obstetrics and Gynecology, Faculty of medicine
Aswan University