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

ConditionDefect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Metformin Hydrochloride Sustained-release Tablets

    Drug

    drug

  • Vaginal repair

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: vaginal repair + metforminExperimental treatment 2 interventions
Group B: vaginal repairActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of menstruation (day)

Duration of menstruation (day)

Time frame
6 months after vaginal repair of CSD
2

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

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

Time frame
6 months after vaginal repair of CSD

Secondary outcomes

1

Subsequent pregnancy outcomes

Subsequent pregnancy outcomes

Time frame
At least 1 year after vaginal repair of CSD
2

Duration of menstruation (day)

Duration of menstruation (day)

Time frame
At least 1 year after vaginal repair of CSD

Other outcomes

Sponsors and contacts

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