About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Metformin Hydrochloride Sustained-release Tablets
Drugdrug
Vaginal repair
Procedure/SurgeryThe procedure of vaginal repair of CSD was shown as following. The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached. The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed. A double layer of 1-0 absorbable interrupted sutures was used to close the incisions.
Treatment groups
Trial outcomes
Primary outcomes
Duration of menstruation (day)
Duration of menstruation (day)
thickness of the remaining muscular layer (TRM) (mm)
The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)
Secondary outcomes
Subsequent pregnancy outcomes
Subsequent pregnancy outcomes
Duration of menstruation (day)
Duration of menstruation (day)
Sponsors and contacts
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