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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 31, 2024 to Jan 30, 2027
    • Study completion date: Jun 30, 2025 to Jun 30, 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2022 to Apr 15, 2023
    • Secondary endpoints revised (2)
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05205317
Lead Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Defect
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov