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
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Rate of successful abortion: defined as complete evacuation 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 120 women in each country 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
- •14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
- •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 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).
干预措施: mifepristone+misoprostol (Drug)
misoprostol
Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).
干预措施: misoprostol+placebo (Drug)
结局指标
主要结局
Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention.
时间窗: 48 hours
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
时间窗: 48 hours
次要结局
- Any heavy bleeding, uterine rupture, or infection requiring additional treatment(start of treatment until discharge)
- Total dose of misoprostol.(Assessed at time of complete abortion with study drug alone or when total maximum dose given.)
- Provision of additional interventions to manage excessive blood loss(from start of treatment until discharge)
- Pain experienced by the woman as self-reported.(Assessed during exit interview.)
- Women's acceptability of the assigned method(Assessed at exit interview)