The Efficacy of A New Crosslinked Hyaluronan Gel in the Prevention of Postoperative Intrauterine Adhesion After Dilatation and Curettage in Women With Delayed Miscarriage: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Incidence of intrauterine adhesion
研究概览
简要总结
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.
详细描述
Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage.
Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.
Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.
Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- 否
入选标准
- •The inclusion criteria:
- •Patients to be female, aged 18-45 years
- •Without previous dilatation and curettage
- •Undergoing dilatation and curettage for the current delayed miscarriage
- •All participants should be with normal liver/rental function and without systemic disease
- •Agree to use adequate forms of contraception throughout the study
- •Be in good compliance with the follow-up examination according to the study protocol.
排除标准
- •Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives
- •Genital tract malformation
- •Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract
- •Suspected genital tuberculosis
- •Abnormal blood coagulation
- •Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness
- •Acute or severe infection
- •Autoimmune diseases.
研究组 & 干预措施
Control
At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.
Treatment
At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula.
干预措施: new crosslinked hyaluronan gel (Device)
结局指标
主要结局
Incidence of intrauterine adhesion
时间窗: 3 months after dilatation and curettage
The number of women with intrauterine adhesion
次要结局
- The adhesion scores of menstrual pattern(3 months after dilatation and curettage)
- Severity(3 months after dilatation and curettage)
- The adhesion scores of extent of uterine cavity involved(3 months after dilatation and curettage)
- Cumulative adhesion score(3 months after dilatation and curettage)
- The adhesion scores of type of adhesion(3 months after dilatation and curettage)