Comparing heparin solution and barrier gel for preventing intrauterine adhesions after surgery
Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy
This study is testing whether a heparin solution or a barrier gel is better at preventing scar tissue in the uterus after surgery for women who have had operative hysteroscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | Female |
| Sponsor | Nadezhda Women's Health Hospital Academic / other |
| Locations | 2 sites (Sofia, Sofia and 1 other locations) |
| Trial ID | NCT05257213 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of heparin solution versus hyaluronic acid barrier gel in preventing intrauterine adhesions following operative hysteroscopy. Patients undergoing this procedure will receive either treatment immediately after surgery, and their outcomes will be assessed through follow-up hysteroscopy 4 to 8 weeks later. The study will measure the incidence and severity of adhesions, as well as any changes in menstrual patterns and fertility over the following year. Data collected will help determine which method is more effective in reducing post-surgical complications.
Who should consider this trial
Good fit: Ideal candidates include women undergoing operative hysteroscopy for conditions like infertility, irregular bleeding, or Asherman syndrome.
Not a fit: Patients with ongoing pregnancy, genital cancer, or pelvic inflammatory disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention of intrauterine adhesions, enhancing recovery and fertility outcomes for patients.
How similar studies have performed: Previous studies have explored similar interventions, but this specific comparison of heparin and barrier gel is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * female sex * indication for operative hysteroscopy including one or more of the following: * infertility, * irregular bleeding, * oligo-/amenorrhea, * Asherman syndrome, * G0-G3 fibroids, * dysmorphic uterus. Exclusion Criteria: * ongoing pregnancy, * genital cancer, * pelvic inflammatory disease, * excessive uterine bleeding.
Where this trial is running
Sofia, Sofia and 1 other locations
- Nadezhda Women's Health Hospital — Sofia, Sofia, Bulgaria (Recruiting)
- Nadezhda Women's Health Hospital — Sofia, Bulgaria (Recruiting)
Study contacts
- Study coordinator: Georgi Stamenov
- Email: g.stamenov1@abv.bg
- Phone: +359888269839
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.