A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Abortion rate
研究概览
简要总结
A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.
The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English-speaking women
- •18 years of age and above
- •Voluntarily choose to undergo pregnancy termination via labor induction
- •An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
- •Able to provide written consent
排除标准
- •Premature rupture of membranes
- •Preterm labor
- •Intrauterine fetal demise
- •Chronic systemic corticosteroid use or adrenal disease
- •Hypersensitivity to prostaglandins
- •Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
- •Known coagulopathy or treatment with anticoagulants
- •Prior caesarean delivery or myomectomy
- •Placenta previa
研究组 & 干预措施
A
Mifepristone followed by labor induction with misoprostol after 6-8 hours
干预措施: Experimental (mifepristone and misoprostol) (Drug)
结局指标
主要结局
Abortion rate
时间窗: 8 hours after misoprostol administration
次要结局
未报告次要终点
