Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Secti… (NCT05205317) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
China100 participantsStarted 2023-04-15
Plain-language 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 have previously demonstrated that vaginal repair of CSD was an relative effective treatment of CSD. However, only 28.2% of the CSD patients normalized to less than 7 days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months post vaginal repair. The previous research suggested that the occurrence of CSD may be related to the aging phenotype of the myometrium. Metformin, as a classic diabetes treatment drug, has an important position in anti-aging therapy. Therefore, the randomized study was designed to evaluate whether the application of metformin in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Over the age of 40 or younger than 18;
✕. Indefinite diagnosis.
✕
What they're measuring
1
Duration of menstruation (day)
Timeframe: 6 months after vaginal repair of CSD
2
thickness of the remaining muscular layer (TRM) (mm)
Timeframe: 6 months after vaginal repair of CSD
Trial details
NCT IDNCT05205317
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
✕. 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)