Assessing the Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of a Semi-Quantitative Pregnancy Test for At-Home Follow-Up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rates
研究概览
简要总结
This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.
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
- Single (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presents for voluntary termination of pregnancy
- •Gestational age ≤ 70 days by last menstrual period plus clinical assessment or ultrasound
- •General good health including the absence of conditions which contraindicate the use of misoprostol for pregnancy termination
- •Agrees to return for follow-up visit and willing to provide an address and/or telephone number for the purposes of follow-up
- •Able to consent to study participation
排除标准
- •Gestational age > 70 days last menstrual period
- •Confirmed or suspected ectopic or molar pregnancy
- •Contraindications to medical abortion include having an intrauterine device in place and history of allergy to misoprostol or other prostaglandins
研究组 & 干预措施
Buccal
Women randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
干预措施: Misoprostol (Drug)
Buccal
Women randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
干预措施: Semi-quantitative pregnancy test (Device)
Sublingual
Women randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
干预措施: Misoprostol (Drug)
Sublingual
Women randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
干预措施: Semi-quantitative pregnancy test (Device)
结局指标
主要结局
Ongoing pregnancy rates
时间窗: 1-2 weeks
The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up.
次要结局
- Incidence of side effects and complications as a measure of safety/ side effects(1-2 weeks)
- Reported acceptability and satisfaction with misoprostol regimen(1-2 weeks)
- Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home(1-2 weeks)
- Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up(1-2 weeks)