Comparing vaginal repair methods for cesarean section scar defects
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
This study is testing if giving Leuprorelin injections to women after vaginal surgery for cesarean section scar defects can help them heal better by delaying their periods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05206682 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of using Leuprorelin, a GnRH-a, to postpone menstruation after vaginal repair in women with cesarean section scar defects (CSD) complicated by adenomyosis. Participants will undergo vaginal excision and suture of the CSD, with one group receiving Leuprorelin injections while the other group will not. The study aims to assess whether delaying menstruation improves the healing prognosis of the scar over a six-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with cesarean section scar defects complicated by adenomyosis and experiencing abnormal uterine bleeding.
Not a fit: Patients with malignant tumors, severe medical problems, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance healing outcomes for women suffering from cesarean section scar defects and adenomyosis.
How similar studies have performed: While the use of GnRH-a in similar contexts has shown promise, this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clearly diagnosed with CSD complicated with adenomyosis 2. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days). 3. The thickness of the remaining muscular layer of CSD was less than 3 mm. 4. Normal range of blood sugar and insulin 5. No serious medical problems (important viscera function in the normal range). 6. uterine fibroids no more than 5cm 7. Sign the informed consent. Exclusion Criteria: 1. Indefinite diagnosis. 2. Malignant tumors. 3. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). 4. Pregnant. 5. Mental diseases. 6. Allergy to the any ingredients of Leuprorelin 7. Unwilling to comply with the research plan.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Jiaotong University xinhua hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wang Xipeng
- Email: steveoizzie@icloud.com
- Phone: +862125078999
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.