A Prospective Multicenter Observational Real-world Study of Retained Products of Conception
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment
研究概览
简要总结
The purpose of this study is to explore the optimal treatment strategy for retained products of pregnancy. Compared with surgical treatment, prospectively observe whether drug-assisted expectant management until the right time for surgery reduce the occurrence of intrauterine adhesions, and thus protect fertility.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Clinical diagnosis of retained products of conception, and ultrasound indicated that the maximum diameter of the lesion ≥0.5cm.
排除标准
- •There is active bleeding requiring immediate surgical intervention;2) combined with obvious infection;3) Combined with severe organ dysfunction, including coagulation dysfunction.
研究组 & 干预措施
Control group
After the patient is confirmed to be included in the study, he/she will be hospitalized directly and will undergo hysteroscopic removal of pregnancy products.
干预措施: Uterine curettage (Procedure)
Experimental group
Wait until a certain time, then surgical treatment if necessary
干预措施: Expectant care (Drug)
结局指标
主要结局
Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment
时间窗: At 3 months after completion of treatment (on the 16th-24th day of the third menstrual cycle post-treatment)
Intrauterine adhesions are diagnosed by three-dimensional transvaginal ultrasound or hysteroscopy. Adhesions are graded according to the American Fertility Society (AFS) classification. This outcome measures the incidence of IUA following different management strategies for retained products of conception, reflecting the degree of endometrial injury.
Number of Participants Requiring Secondary Surgical Evacuation
时间窗: From initiation of treatment to 3 months post-treatment
Secondary surgical evacuation is defined as any additional surgical procedure (hysteroscopic or curettage) required for complete removal of retained products of conception after the initial management strategy. This outcome reflects the effectiveness of the initial treatment approach and the number of intrauterine procedures.
Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception
时间窗: From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year
Pregnancy is defined as a positive serum β-hCG test and confirmed intrauterine gestational sac by ultrasound. This outcome is assessed only in participants with fertility intent and reflects the ultimate goal of fertility preservation.
次要结局
- Number of Participants with Active Bleeding During Expectant Management(From enrollment to hospitalization or intervention, assessed up to 3 months)
- Number of Participants with Pelvic Infection During Expectant Management(From enrollment to hospitalization or intervention, assessed up to 3 months)
- Number of Participants with Live Birth Following Subsequent Pregnancy(At delivery, assessed up to 1 year after pregnancy confirmation)
- Intraoperative Blood Loss During Hysteroscopic Surgery(During the surgical procedure)
- Endometrial Thickness at 3 Months Post-Treatment(At 3 months after treatment (on the 16th-24th day of the third menstrual cycle post-treatment))
研究者
Xu dabao
MD
The Third Xiangya Hospital of Central South University