Actively Recruiting
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-24
100
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to under 40 years
- Diagnosed clearly with cesarean section scar defect (CSD)
- Experiencing abnormal uterine bleeding with menstruation lasting more than 10 days
- Thickness of remaining muscular layer of CSD less than 3 mm
- Normal blood sugar and insulin levels
- No serious medical problems; important organ functions within normal range
- No uterine fibroids, endometriosis, or adenomyosis
- No malignant tumors
- Signed informed consent
You will not qualify if you...
- Age under 18 or over 40 years
- Unclear diagnosis of CSD
- Presence of malignant tumors
- Severe medical problems such as severe liver, kidney, respiratory, heart disease, uncontrolled diabetes, epilepsy, or organ dysfunction
- Contraindications to metformin including high creatinine levels, hypersensitivity, metabolic acidosis, or use of interacting drugs
- Pregnancy
- Mental illness
- Unwillingness to follow the research plan
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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