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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.
The previous research suggested that the occurrence of cesarean section scar defect (CSD) may be related to the aging phenotype of the myometrium. The aging of the myometrium in some cesarean section patients reduces the proliferation and repair of smooth muscle cells and endometrial cells to a certain extent. The prognosis of vaginal repair is poor and the repair of the endometrium during menstruation is not good.
Metformin, as a classic diabetes treatment drug, has an important position in anti-aging therapy. Its research and application range is the widest, and significant results have been achieved in a number of clinical trials. At the same time, its side effects are less than other anti-aging drugs, and the patient adaptability is better. It maybe the best choice for the treatment of anti-aging diseases. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaginal repair + metformin | Experimental | CSD patients were treated with vaginal repair of CSD in combination with metformin (Boke, 500 mg, Wanhui Shuanghe, Beijing, China) as an oral medicine (abbreviated as VR + metformin). In the group of VR + metformin, the patients start oral metformin from one month before the operation to 6 months after the operation. The dose is 500mg twice a day. The detailed procedure of VR has been described in investigators' previous study. |
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| vaginal repair | Active Comparator | The 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Hydrochloride Sustained-release Tablets | Drug | drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of menstruation (day) | Duration of menstruation (day) | 6 months after vaginal repair of CSD |
| thickness of the remaining muscular layer (TRM) (mm) | The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI) | 6 months after vaginal repair of CSD |
| Measure | Description | Time Frame |
|---|---|---|
| Subsequent pregnancy outcomes | Subsequent pregnancy outcomes | At least 1 year after vaginal repair of CSD |
| Duration of menstruation (day) | Duration of menstruation (day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
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| Vaginal repair | Procedure | The 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. |
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| At least 1 year after vaginal repair of CSD |