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Diabetes drug could boost surgery for C-Section scar problems

NCT ID NCT05205317

Disease control Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares vaginal repair surgery alone versus surgery plus metformin for women with a cesarean scar defect that causes prolonged menstrual bleeding. About 100 women under 40 with a thin scar muscle layer will be randomly assigned to one of the two groups. The goal is to see if metformin, an anti-aging drug, helps the scar heal better and shortens periods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin (a diabetes drug) and vaginal repair surgery
What this could lead to
If it works, this could offer a more effective treatment for cesarean scar defect, reducing heavy periods and improving quality of life.
What could go wrong
This is a small, early-stage trial with only 100 participants. Metformin may not improve outcomes, and surgery carries typical risks like infection or scarring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients are younger than 40 and over the age of 18. 2. Clearly diagnosed with CSD. 3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 10 days). 4. The thickness of the remaining muscular layer of CSD was less than 3 mm. 5. Normal range of blood sugar and insulin 6. No serious medical problems (important viscera function in the normal range). 7. No uterine fibroids, endometriosis, adenomyosis 8. No malignant tumors. 9. Sign the informed consent. Exclusion Criteria: 1. Over the age of 40 or younger than 18; 2. Indefinite diagnosis. 3. Malignant tumors. 4. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). 5. 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) 6. Pregnant. 7. Mental diseases. 8. Unwilling to comply with the research plan.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DEFECT

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200092, China