A Randomized, Placebo-Controlled, Double-Blinded Study of Mifepristone in Midtrimester Termination of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Time from start of induction to fetal delivery
研究概览
简要总结
Mid-second trimester medical terminations of pregnancy require admission to the hospital for the length of time it takes a woman to abort. The current protocol at BMC uses intra-amniotic digoxin injection the day prior to admission. The following day, the woman is admitted and given sequential doses of misoprostol until delivery occurs. The average length of time between the first dose of misoprostol and delivery is 12 hours, requiring most women to stay overnight. This is a randomized, placebo-controlled, double-blinded study designed to determine whether adding mifepristone significantly reduces the induction interval time (time between starting the first misoprostol and delivery) required for a second trimester termination.
详细描述
This is a randomized, placebo-controlled, double-blinded study.
Allocation Method: Women will be randomized using a computer-run random number table. Tablets will be placed in capsules by the pharmacy according to the randomization chart.
Blinding: Subjects will receive a capsule containing either 200 mg of mifepristone or 250 mg Vitamin C. Neither she nor the researcher will be aware of which medication she receives.
Outcomes: The primary outcome measured will be the mean interval from first misoprostol dose to fetal expulsion. Secondary outcomes include the proportion of women delivering within 24 hours from the first dose of misoprostol and the proportion of women with a complete delivery not requiring additional treatment for retained placenta. We will also compare the amount of pain medication used, as well as the length of hospital stay between the two groups.
Inclusion criteria Inclusion criteria: · Need for second trimester induction for termination of pregnancy · Gestational age of 18-23 weeks · At least 18 years of age or 16 years old with parental consent No medical contraindication to the use of digoxin and misoprostol for the purposes of inducing abortion. · Able and willing to give informed consent in English or Spanish
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
- Double
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •16 years of age or over
- •able to give informed consent in English or Spanish
- •Requesting termination of pregnancy
排除标准
- •Under 16 years of age
- •rupture membranes or intrauterine death
结局指标
主要结局
Time from start of induction to fetal delivery
次要结局
未报告次要终点