Assessment of Uterine HealingCOCLIECHONCT05785559
Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation
A study testing uterine biopsies in people with Assessment of Uterine Healing, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Assessment of Uterine Healing
- What is being tested?
- uterine biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Assessment of Uterine Healing
- Being tested
- uterine biopsies
- Keywords
- uterine scarring, isthmocele, caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine biopsiesProcedure or surgery
uterine biopsies performed on the areas of cesarean section scars
| Study group | Role | What they receive |
|---|---|---|
| Scarred uterus | Experimental | 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. Receives: Procedure: uterine biopsies |
| Scar dehiscence surgery | Experimental | 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. Receives: Procedure: uterine biopsies |
| Healthy uterus | Experimental | 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" Receives: Procedure: uterine biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the process of uterine healing
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 "
Measured: 8 weeks
Secondary outcomes (1)
Histological aspects of the scar
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Uterine HealingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Uterine biopsy and cesarean scar dehiscence
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine CAPMAS, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785559
- Sponsor's protocol ID
- APHP220952
- Acronym
- COCLIECHO
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation
- ClinicalTrials.gov ID
- NCT05785559
- Acronym / sponsor ID
- COCLIECHO / APHP220952
- Conditions
- Assessment of Uterine Healing
- Keywords
- uterine scarring, isthmocele, caesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Uterine biopsy and cesarean scar dehiscence
| Arm | Type | Receives |
|---|---|---|
| Scarred uterus | Experimental | Procedure: uterine biopsiesPatients 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. |
| Scar dehiscence surgery | Experimental | Procedure: uterine biopsiesPatients 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. |
| Healthy uterus | Experimental | Procedure: uterine biopsiesPatients 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" |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Common to all groups:
- Adult patient,
- Signed consent for participation in the study
- Patient affiliated to a social security scheme (excluding AME)
- Support for a scheduled or emergency caesarean (excluding patients having an emergency caesarean (red code: caesarean within 15 minutes))
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uterine biopsiesuterine biopsies performed on the areas of cesarean section scars | Procedure or surgery | Healthy uterus, Scar dehiscence surgery, Scarred uterus |
Primary outcome
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 "
1 secondary outcome
Histological aspects of the scar
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perrine CAPMAS principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterine biopsies in people with Assessment of Uterine Healing, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perrine CAPMAS (0145217714, perrine.capmas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the process of uterine healing (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.