NCT05119439终止4 期
An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy
Gynuity Health Projects4 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年10月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason
研究概览
简要总结
This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Seeking medical abortion services at one of the enrolling clinics
- •Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days
- •Meet standard eligibility criteria for medical abortion
- •Be able to return to clinic for in-person follow up
- •Speak/read/write English or Spanish
- •Have access to a mobile phone with texting capability
- •Be in general good health
- •Be willing and able to sign consent forms
- •Agree to comply with the study procedures and follow up.
排除标准
- •Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.)
- •With known allergies or other contraindications to mifepristone or misoprostol
- •Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.
研究组 & 干预措施
78-84 days of gestational age
Experimental
Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days.
干预措施: Mifepristone + 2 doses of misoprostol 800 mcg (Drug)
结局指标
主要结局
Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason
时间窗: 7-36 days after initial visit
Proportion of women who achieve complete abortion with medication only and without aspiration or D\&E
次要结局
- Proportion of participants who report each individual side effect(7-14 days after initial visit)
- Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization(7-14 days after initial visit)
- Proportion of participants who determine method acceptable(7-36 days after initial visit)
研究者
研究点 (4)
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