Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Secti… (NCT05205317) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
China100 participantsStarted 2023-04-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of menstruation (day)
Timeframe: 6 months after vaginal repair of CSD
2
thickness of the remaining muscular layer (TRM) (mm)
Timeframe: 6 months after vaginal repair of CSD
Trial details
NCT IDNCT05205317
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
. 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)