Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean (FAUCS)

NCT ID: NCT05536869

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-27

Study Completion Date

2023-07-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective of this study is to compare the time taken to obtain "street fitness" status for women after extraperitoneal cesarean section compared to women after a classic cesarean section.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section; Dehiscence Extra Peritoneal Caesarean Section

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with intraperitoneal caesarean section

Group Type ACTIVE_COMPARATOR

Caesarean

Intervention Type PROCEDURE

Two different caesarean section techniques : intra or extraperitoneal

patient with extraperitoneal caesarean section

Faucs technique

Group Type EXPERIMENTAL

Caesarean

Intervention Type PROCEDURE

Two different caesarean section techniques : intra or extraperitoneal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caesarean

Two different caesarean section techniques : intra or extraperitoneal

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient scheduled for a caesarean between 38 and 42 weeks pregnant
* Patient aged between 18 and 42 years old
* Singleton
* Caesarean section with a theoretical operating time \< 1 hour (without major complications)
* Patient affiliated to a social security scheme
* Patient having signed the free and informed consent.

Exclusion Criteria

* BMI \> 40
* High blood pressure treated intravenously
* Pre-existing diabetes in pregnancy
* Allergy to analgesics
* Prenatal depression
* Pathological insertion of the placenta (placenta previa or accreta).
* History of major pelvic or abdominal surgery (myomectomy, peritonitis) other than caesarean section or minor surgery.
* Addiction (drugs)
* Pre-existing psychiatric pathology leading to a risk of impaired judgment or behavior.
* Patient participating in another clinical study with a drug or medical device
* Protected patient: Adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient hospitalized without consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Les Franciscaines Clinic

Versailles, IDF, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean-François Oudet

Role: CONTACT

0683346567

Marie-Hélène Barba

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bénédicte Simon

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A01220-57

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.