Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- complete abortion rate
研究概览
简要总结
The purpose of this study is to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.
详细描述
Women usually request an abortion when they have experienced an emergency contraception (EC) failure; this population represents 13% of all early pregnancy terminations in China. Many women would prefer to choose a medical abortion in order to avoid anesthesia, over a surgical operation. However, medical termination of a pregnancy after mifepristone EC failure has not been studied although it has already been extensively practiced by empirical means in China. There is no clarification in literature as to whether mifepristone is still effective in medical abortion with its previous failure experience in EC. This randomized study was aimed to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.
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
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants included in the study were women aged 16 years or older
- •with good general health,
- •experiencing a mifepristone emergency contraception failure,
- •presenting an intrauterine singleton pregnancy confirmed by pelvic ultrasound scan, with a crown-rump length compatible within 56 days of gestation at the enrolled day, and
- •seeking a medical abortion for unwanted pregnancy.
- •Women who had a threatened abortion or a failure pregnancy were also included.
- •Participants were required to sign an informed consent form before enrolment, willing to comply with the schedule of follow-up visits and willing to undergo surgical aspiration if indicated.
排除标准
- •The exclusion criteria included suspected or proven ectopic pregnancy,
- •allergy or contraindications for mifepristone (chronic systemic corticosteroid therapy, adrenal insufficiency) or misoprostol (hypertension, mitral stenosis, severe asthma, glaucoma, sickle cell anemia and hypotension),
- •history or evidence of thromboembolism, cardiovascular disease or liver disease, hemoglobin ≤ 90 g/l, heavy smoking (more than 10 per day),
- •presence of an intrauterine device, and breastfeeding.
- •Other exclusion criteria included participants who had EC failure because incorrect use, for example, having further unprotected intercourse after EC.
研究组 & 干预措施
Mf+Ms
The women in mifepristone combined misoprostol group (Mf+Ms) received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally
干预措施: mifepristone combined misoprostol (Drug)
Ms-alone
The control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3.
干预措施: misoprostol alone protocol (Drug)
结局指标
主要结局
complete abortion rate
时间窗: study day 17 (14 days after misoprostol)
次要结局
- side effects, timing of expulsion and duration of bleeding(timing of expulsion at day 17, others at 45day after abortion)