Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.
研究概览
简要总结
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meet legal criteria to obtain abortion
- •Present with closed cervical os and no vaginal bleeding
- •Live fetus at time of presentation for service
- •Have no contraindications to study procedures, according to provider
- •Be able to consent to procedure, either by reading consent document or by having consent document read to her
- •Be willing to follow study procedures
排除标准
- •Known previous transmural uterine incision
- •Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- •Any contraindications to vaginal delivery, including placenta previa
- •Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
研究组 & 干预措施
Mifepristone + Misoprostol
200 mg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
干预措施: Mifepristone+misoprostol (Drug)
Misoprostol
Placebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses
干预措施: Placebo+Misoprostol (Drug)
结局指标
主要结局
Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.
时间窗: every 3 hours
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours.
时间窗: 48 hours
次要结局
- Provision of additional interventions to manage excessive blood loss.(Within 30 days of mifepristone administration.)
- Total dose of misoprostol.(Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration.)
- Any heavy bleeding, uterine rupture, or infection requiring additional treatment(Within 30 days of mifepristone administration.)
- Pain experienced by the woman(Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.)
- Women's acceptability of the assigned method(Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.)