The Efficacy and Safety of a New Cross-linked Hyaluronan Gel to Prevent Adhesion After Ultrasound-guided Manual Vacuum Aspiration (USG-MVA): A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of IUA
研究概览
简要总结
The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage.
- To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients.
- To examine the rate of complications or side effects with the NCH gel.
- To assess the subsequent menstrual history and reproductive outcome in both groups of patients.
详细描述
There is limited data to evaluate the incidence of IUA after using this NCH gel in patients undergoing surgical evacuation via USG-MVA for the treatment of first-trimester miscarriage. Previous RCT showed a significant reduction in IUA with the use of NCH gel, with IUA detected in only 9.5% of patients with NCH gel applied compared to 24.1% in the control group. However, the group did not involve patients undergoing surgical evacuation by USG-MVA.
Therefore, the objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment of first-trimester miscarriage.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years old or above
- •No previous history of IUA/ Asherman's syndrome
- •No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
- •No previous history of therapeutic hysteroscopic surgeries
- •Voluntary informed consent and understanding of study
排除标准
- •previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
- •suspicion of molar pregnancy
- •genital tract malformation
- •suspicion of active infection or genital tract malignancy or genital tuberculosis
- •abnormal blood coagulation
- •inability to tolerate pelvic examination known
- •suspected intolerance of hypersensitivity to NCH gel or its derivatives
- •patient refusal
结局指标
主要结局
Incidence of IUA
时间窗: 8-12 weeks after MVA
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.
次要结局
- Subsequent reproductive outcome(8-12 weeks after MVA)
- Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score(8-12 weeks after MVA)
- Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score(8-12 weeks after MVA)
- Complications or side effects with the NCH gel.(8-12 weeks after MVA)
- Subsequent menstrual frequency(8-12 weeks after MVA)
研究者
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong