Status:
RECRUITING
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Defect
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Cesarean section scar defect (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. The investigators...
Detailed Description
The previous research suggested that the occurrence of cesarean section scar defect (CSD) may be related to the aging phenotype of the myometrium. The aging of the myometrium in some cesarean section ...
Eligibility Criteria
Inclusion
- Patients are younger than 40 and over the age of 18.
- Clearly diagnosed with CSD.
- Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days).
- The thickness of the remaining muscular layer of CSD was less than 3 mm.
- Normal range of blood sugar and insulin
- No serious medical problems (important viscera function in the normal range).
- No uterine fibroids, endometriosis, adenomyosis
- No malignant tumors.
- Sign the informed consent.
Exclusion
- Over the age of 40 or younger than 18;
- Indefinite diagnosis.
- Malignant tumors.
- With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- 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)
- Pregnant.
- Mental diseases.
- Unwilling to comply with the research plan.
Key Trial Info
Start Date :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05205317
Start Date
April 15 2023
End Date
June 30 2025
Last Update
October 2 2024
Active Locations (1)
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1
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092