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

March 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Le Kremlin Bicêtre, France, 94275
        • AP-HP, Bicêtre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze the process of uterine healing
Time Frame: 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 "
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological aspects of the scar
Time Frame: 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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Perrine CAPMAS, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP220952

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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