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Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect

RecruitingNAAges 18 Years - 40 YearsFemaleXinhua Hospital, Shanghai Jiao Tong University Scโ€ฆ
NCT05205317 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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 \>124ฮผmol/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.
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What it tests

  • Metformin Hydrochloride Sustained-release Tablets
  • Vaginal repair
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Where

1 site
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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