Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 441
- 试验地点
- 2
- 主要终点
- Number of women with a complete abortion using study drug alone without recourse to surgical intervention
研究概览
简要总结
This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.
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
- •Gestational age < 63 days since LMP, confirmed by ultrasound or clinical assessment.
- •General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
- •Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- •Able to consent to study participation.
排除标准
- •Gestational age > 63 days LMP
- •Confirmed or suspected ectopic or molar pregnancy
- •Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.
研究组 & 干预措施
mifepristone+misoprostol
200 mg mifepristone + 800 mcg buccal misoprostol
干预措施: medical abortion (Drug)
buccal misoprostol
2 doses of 800 mcg buccal misoprostol
干预措施: medical abortion (Drug)
结局指标
主要结局
Number of women with a complete abortion using study drug alone without recourse to surgical intervention
时间窗: one week from initial treatment
Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens
次要结局
- Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam(one week from initial treatment)
- Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration(one week from initial treatment)
- Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam(one week from initial treatment)
- Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance(one week from initial treatment)