Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 3
- 主要终点
- Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
研究概览
简要总结
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.
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 (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Closed cervical os and no vaginal bleeding
- •Live fetus at time of presentation for service
- •No contraindications to medical abortion and study procedures, according to provider
- •Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
- •Willing to follow study procedures
排除标准
- •Known previous transmural uterine incision
- •> 5 parity
- •Signs and symptoms of infection
- •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 at home 24 hours before miso dosing starts
All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.
Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.
干预措施: Mifepristone (Drug)
Mifepristone and first dose of misoprostol simultaneously.
Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.
Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
时间窗: Within 1 week
Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
次要结局
- Time interval from the mifepristone dose to abortion(Within 1 week)
- Total dose of misoprostol administered(Within 1 week)
- Induction to abortion interval(Within 1 week)
- Women's acceptability of the assigned method.(Within 1 week)
- Rate of fetal expulsion(Within 1 week)
- Provision of additional interventions(Within 1 week)