UnknownNot Applicable

Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation

France90 participantsStarted 2023-04-01

Plain-language summary

Caesarean section is one of the most common surgical procedures. The multiplication of uterine scars leads to an increase in complications and in particular those related to poor healing such as isthmocele or uterine rupture. The processes of uterine healing at the histological scale are little known. The main objective of the research is to analyze the process of uterine healing by means of uterine biopsies performed on the areas of cesarean section scars.

Who can participate

Age range

18 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: * Common to all groups: * Adult patient, * Signed consent for participation in the study * Patient affiliated to a social security scheme (excluding AME) Group 1: * Support for a scheduled or emergency caesarean (excluding patients having an emergency caesarean (red code: caesarean within 15 minutes)) * Scarred uterus: having already benefited from a caesarean section Group 2: \- Surgical management of caesarean section scar dehiscence after a caesarean section Group 3 (control): * Support for a scheduled or emergency caesarean (excluding patients having an emergency caesarean (red code: caesarean within 15 minutes) * Healthy uterus: no history of caesarean section (history of vaginal delivery or first pregnancy) Exclusion Criteria: * Disorder of hemostasis at risk of bleeding * Anatomopathological sampling not feasible * Patient with a history of upper genital infections * Patient under legal protection (guardianship, curatorship) * Patient who does not speak or understand French * Patient unable to answer questions or with difficulty in expressing herself

Questions worth asking your doctor

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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?

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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

Analyze the process of uterine healing

Timeframe: 8 weeks

Trial details

NCT IDNCT05785559

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

Contact for this trial

Perrine CAPMAS

0145217714 perrine.capmas@aphp.fr

View on ClinicalTrials.gov More Assessment of Uterine Healing trials