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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05785559
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
15
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: uterine biopsies
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Uterine biopsy and cesarean scar dehiscenceUterine biopsy and cesarean scar dehiscence
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Scarred uterus

Patients who have already undergone one or more cesarean section(s) during a previous pregnancy and for whom a cesarean section is indicated on a scheduled or emergency basis.

Procedure: uterine biopsies
uterine biopsies performed on the areas of cesarean section scars
Experimental: Scar dehiscence surgery

Patients who have already undergone one or more caesarean section(s) and for whom the surgical management of a dehiscence of a caesarean section scar is indicated outside of pregnancy.

Procedure: uterine biopsies
uterine biopsies performed on the areas of cesarean section scars
Experimental: Healthy uterus

Patients with no history of caesarean section, pregnant with an indication for caesarean section: patients who have never had a caesarean section during a previous pregnancy or who are pregnant with their first pregnancy and for whom a caesarean section is indicated scheduled or urgently"

Procedure: uterine biopsies
uterine biopsies performed on the areas of cesarean section scars

Outcome Measures

Primary Outcome Measures

  1. Analyze the process of uterine healing [8 weeks]

    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 "

Secondary Outcome Measures

  1. Histological aspects of the scar [8 weeks]

    The secondary evaluation criteria will be the correlation of the histological aspects of the scar with the clinical and ultrasound data. The objective is to look for risk factors for poor uterine healing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AP-HP, Bicêtre Hospital Le Kremlin Bicêtre France 94275

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Perrine CAPMAS, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05785559
Other Study ID Numbers:
  • APHP220952
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
uterine scarring
isthmocele
caesarean section

Study Results

No Results Posted as of Mar 27, 2023