Expectant Management Versus Medical Management of Retained Products of Conception After Induced Abortion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- RPOC rate
研究概览
简要总结
Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion
详细描述
An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 < age < 45 year old
- •Thick irregular endometrium >12 mm on trans-vaginal ultrasound
排除标准
- •Endometritis
- •Cervical opening > 1 cm
- •Uterine abnormalities
- •Contraindication to Misoprostol treatment
研究组 & 干预措施
Medical
SL 800 mcg Misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
RPOC rate
时间窗: 2 months
RPOC rate in repeat ultrasound scan performed 5 weeks after randomization
次要结局
- Adhesions(2 months)
- Bleeding(2 months)
研究者
Eli Sprecher, MD
MD, PhD. Deputy Director Research & Development
Tel-Aviv Sourasky Medical Center