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临床试验/NCT05085067
NCT05085067招募中不适用

The Efficacy of Auto-crosslinked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception:a Randomized Controlled Trial

Fu Xing Hospital, Capital Medical University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
86
试验地点
1
主要终点
Concentration of the menstrual pattern

研究概览

简要总结

Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.

After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: [1] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; [2] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of retained products of conception
  • Written consent obtained

排除标准

  • Patients with severe complications of medicine and surgery
  • Acute or chronic genital tract inflammation
  • No understanding or approving the randomized controlled trial

研究组 & 干预措施

Group A: no auto-cross linked hyaluronic acid gel

No Intervention

no auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception

Group B: infusing auto-cross linked hyaluronic acid gel

Experimental

infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception

干预措施: auto-crossed-linked hyaluronic acid gel (Other)

结局指标

主要结局

Concentration of the menstrual pattern

时间窗: at 3 months after the initial surgery

Adhesion reformation rate at third-look hysteroscopy

时间窗: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.

Adhesion score at third-look hysteroscopy

时间窗: A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.

Pregnancy rate

时间窗: at 12-month after the initial surgery

次要结局

  • Rate of complications(up to 12 weeks)

研究者

发起方
Fu Xing Hospital, Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Xue

principal investigator

Fu Xing Hospital, Capital Medical University

研究点 (1)

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