Comparing VR and Metformin for Cesarean Section Scar Defect Treatment
Comparison of the Therapeutic Effects of Vaginal Repair and Vaginal Repair + Metformin in the Treatment of Cesarean Section Scar Defect
This study is testing if adding metformin to vaginal repair can help women with cesarean section scar defects have better healing and less menstrual bleeding compared to just vaginal repair alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05205317 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of vaginal repair combined with metformin versus vaginal repair alone in treating cesarean section scar defects (CSD). CSD is linked to abnormal uterine bleeding, and the study aims to improve outcomes for women suffering from prolonged menstrual flow. Participants will be randomized to receive either the combination treatment or the standard vaginal repair. The trial seeks to determine if metformin, known for its anti-aging properties, can enhance the healing process and reduce menstrual duration.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 diagnosed with CSD and experiencing prolonged menstrual flow.
Not a fit: Patients over 40, those with malignant tumors, or severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve menstrual health and quality of life for women with cesarean section scar defects.
How similar studies have performed: While the use of metformin in this context is novel, previous studies have shown its effectiveness in other clinical applications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients are younger than 40 and over the age of 18. 2. Clearly diagnosed with CSD. 3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days). 4. The thickness of the remaining muscular layer of CSD was less than 3 mm. 5. Normal range of blood sugar and insulin 6. No serious medical problems (important viscera function in the normal range). 7. No uterine fibroids, endometriosis, adenomyosis 8. No malignant tumors. 9. Sign the informed consent. Exclusion Criteria: 1. Over the age of 40 or younger than 18; 2. Indefinite diagnosis. 3. Malignant tumors. 4. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). 5. Contraindications to metformin (baseline creatinine \>124μmol/L, hypersensitivity to metformin, or a metabolic acidosis), use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs) 6. Pregnant. 7. Mental diseases. 8. Unwilling to comply with the research plan.
Where this trial is running
Shanghai, Shanghai Municipality
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
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.