Clinical trial NCT05785559: Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation
Official title: Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Assessment of Uterine Healing
Keywords: uterine scarring
isthmocele
caesarean section
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Uterine biopsy and cesarean scar dehiscence
Primary purpose: OTHER

Brief 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.

Detailed description: Our hypothesis is that there is a histological healing defect visible on an anatomopathologic examination of the scar. This poor uterine healing on histological scale is probably associated with uterine healing defects visible on pelvic ultrasound (scar dehiscence) and clinical criteria (number of caesareans, symptoms).

The objective of the research is to analyze uterine scarring by means of uterine biopsies performed on the areas of cesarean section scars. The uterine scarred areas will be analyzed histologically according to specific criteria and compared to healthy uterine areas. Histological characteristics will be compared with clinical and ultrasound data.

Eligibility criteria: 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

Primary outcomes:
measure: Analyze the process of uterine healing
timeFrame: 8 weeks
Secondary outcomes:
measure: Histological aspects of the scar
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: APHP
name: Perrine CAPMAS
role: PRINCIPAL_INVESTIGATOR
References: