A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Rate of successful abortion by 24 hours
研究概览
简要总结
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.
详细描述
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meet 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
- •Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
研究组 & 干预措施
Sublingual misoprostol
200mg mifepristone + 400mcg sublingual misoprostol q3h
干预措施: Mifepristone (Drug)
Sublingual misoprostol
200mg mifepristone + 400mcg sublingual misoprostol q3h
干预措施: Sublingual misoprostol (Drug)
Buccal misoprostol
200mg mifepristone + 400mcg buccal misoprostol q3h
干预措施: Mifepristone (Drug)
Buccal misoprostol
200mg mifepristone + 400mcg buccal misoprostol q3h
干预措施: Buccal misoprostol (Drug)
结局指标
主要结局
Rate of successful abortion by 24 hours
时间窗: 24 hours following the start of misoprostol
Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
Rate of successful abortion by 48 hours
时间窗: 48hours following the start of misoprostol
Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
次要结局
- Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).(48 hours)
- Pain scale (1-7) as reported by women on questionnaire(from first drug dose to complete expulsion as documented on study forms, up to 72 hours)
- Percentage of patients requiring provision of additional interventions.(from first drug dose to complete expulsion as documented on study forms, up to 72 hours)
- Total number of doses of misoprostol.(from first drug dose to complete expulsion as documented on study forms, up to 72 hours)
- Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire(from first drug dose to complete expulsion as documented on study forms, up to 72 hours)
- Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment(1 month)