The Success Rate After Expectant & Medical Management for a Retained Product of Conception After Medical Termination of Pregnancy in First Trimester Spontaneous Abortion-RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluate effectiveness of medical management
研究概览
简要总结
This prospective randomized controlled trial evaluates the success of medical versus expectant management for retained products of conception (RPOC) following medical abortion with mifepristone and misoprostol for delayed miscarriage in the first trimester. Women aged 18-45 with sonographic evidence of RPOC (endometrial thickness >10 mm with Doppler flow) will be randomized into two groups: medical management with misoprostol or expectant management (observation only). Follow-up will include ultrasound evaluations over six weeks to monitor uterine clearance and determine further interventions.
Population: 150 participants, with 75 in each group. Inclusion Criteria: Stable women with RPOC after medical abortion, bleeding comparable to menstrual flow, and no fever.
Exclusion Criteria: Hemodynamic instability, excessive bleeding, fever, or specific endometrial thickness criteria.
Outcome Measures: RPOC resolution, need for surgical intervention, complications, and sonographic changes.
Study Duration: Five years. Data on demographics, medical history, and ultrasound findings will be analyzed using SPSS, with results informing optimal management strategies for RPOC after first-trimester medical abortion.
详细描述
Study Goals:
- Primary Objectives: Evaluate the effectiveness of medical management with misoprostol and expectant management for retained products of conception (RPOC) following medical abortion for delayed miscarriage in the first trimester (up to 12 weeks).
- Secondary Objectives: Assess the safety and complications of expectant versus medical management of RPOC.
Study Design:
- Prospective study involving women diagnosed with RPOC following medical abortion with mifepristone and misoprostol for delayed miscarriage in the first trimester.
- Participants will be randomized into two groups: medical management with misoprostol and expectant management (observation only).
- Data will be collected through three follow-up visits over six weeks, with ultrasound evaluations to monitor uterine content and decide on further interventions, if necessary.
Population:
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
- 否
入选标准
- •RPOC identified on ultrasound after medical abortion, defined as endometrial thickness >10 mm with Doppler flow into the uterine cavity.
- •Hemodynamically stable women with bleeding comparable to menstrual flow, without fever.
排除标准
- •Hemodynamic instability, excessive bleeding, or fever.
- •Endometrial thickness >40 mm.
- •Endometrial thickness <10 mm without Doppler flow into the cavity.
- •Presence of a gestational sac within the uterine cavity.
- •Women who received two doses of misoprostol before evaluation.
研究组 & 干预措施
• Participants will be randomized into two groups: medical management with misoprostol and expectant
expectant management (observation only).
medical management
medical management with misoprostol
干预措施: medical management with misoprostol (Drug)
结局指标
主要结局
Evaluate effectiveness of medical management
时间窗: From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks.
Evaluate the effectiveness of medical management with misoprostol and expectant management for retained products of conception (RPOC) following medical abortion for delayed miscarriage in the first trimester (up to 12 weeks).
次要结局
- Assess the complication of expectant versus medical management of RPOC.(From the time of enrollment until the completion of follow-up for the first trimester abortion- up to 12 weeks)
研究者
Yael Yagur
Dr Yael Yagur
Meir Medical Center