Using a new gel to prevent adhesions after first-trimester miscarriage treatment
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
This study is testing a new gel to see if it can help prevent scar tissue from forming in the uterus after treatment for a miscarriage in the first trimester.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05360186 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a new cross-linked hyaluronan gel in preventing intrauterine adhesions (IUA) following surgical evacuation for first-trimester miscarriage. The study is a prospective, randomized controlled trial that compares the incidence of IUA in patients treated with the gel versus a control group. It also assesses the severity of adhesions, rates of complications, and subsequent reproductive outcomes. The trial aims to provide more data on the gel's efficacy in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are undergoing surgical evacuation for first-trimester miscarriage and have no history of intrauterine adhesions.
Not a fit: Patients with a history of intrauterine adhesions, previous surgical procedures affecting the uterus, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this gel could significantly reduce the risk of intrauterine adhesions, improving reproductive outcomes for women after miscarriage.
How similar studies have performed: Previous studies have shown success with similar approaches, indicating a potential for this gel to effectively reduce intrauterine adhesions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Elaine NG
- Email: elaineng@cuhk.edu.hk
- Phone: 35052745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.