Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Rate of successful abortion
研究概览
简要总结
The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with gestations through 70 days, as well as the acceptability of this method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have an intrauterine pregnancy consistent with gestational age less than 71 days;
- •Be able to understand and willing to sign a consent form;
- •Be eligible for medical abortion according to the clinician's assessment;
- •Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
- •Be willing to provide an address and/or telephone number for purposes of follow-up;
- •Agree to comply with the study procedures and visit schedule.
排除标准
- •Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- •Chronic renal failure;
- •Concurrent long-term corticosteroid therapy;
- •History of allergy to mifepristone, or misoprostol or another prostaglandin;
- •History of hemorrhagic disorders or concurrent anticoagulant therapy;
- •History of inherited porphyrias;
- •Intrauterine device in place (must be removed before mifepristone is administered).
研究组 & 干预措施
Simplified medical abortion
Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.
干预措施: Mifepristone (Drug)
Simplified medical abortion
Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Rate of successful abortion
时间窗: 2 weeks after mifepristone administration
次要结局
未报告次要终点