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NCT Number: NCT05205317

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location status: Recruiting

Location contact

Xipeng Wang, Doctor

CONTACT

[email protected]

86-2507-8999

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Normal range of blood sugar and insulin
  • No serious medical problems (important viscera function in the normal range).
  • No uterine fibroids, endometriosis, adenomyosis
  • No malignant tumors.
  • Sign the informed consent.

Exclusion criteria

  • 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).
  • Contraindications to metformin (baseline creatinine >124μmol/L, hypersensitivity to metformin, or a metabolic acidosis), use of drugs that might interact with metformin (glyburide, furosemide, or cationic drugs)
  • Pregnant.
  • Mental diseases.
  • Unwilling to comply with the research plan.

Treatment and study plan

Metformin Hydrochloride Sustained-release Tablets

Drug

drug

Other names: Boke

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.

Primary outcomes

  1. Duration of menstruation (day)

    Time frame: 6 months after vaginal repair of CSD

    Duration of menstruation (day)

  2. thickness of the remaining muscular layer (TRM) (mm)

    Time frame: 6 months after vaginal repair of CSD

    The thickness of the remaining muscular layer is measured by magnetic resonance imaging (MRI)

Secondary outcomes

  1. Subsequent pregnancy outcomes

    Time frame: At least 1 year after vaginal repair of CSD

    Subsequent pregnancy outcomes

  2. Duration of menstruation (day)

    Time frame: At least 1 year after vaginal repair of CSD

    Duration of menstruation (day)

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 25, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.