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

Not Applicable

Recruiting

• Conditions: Extra Peritoneal Caesarean Section; Cesarean Section; Dehiscence
• Interventions: Procedure: Caesarean

• Registration Number: NCT05536869
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-12-27
• Status Verified: 2022-09
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-13
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15
• Primary Completion: 2022-09-27
• Study Completion: 2023-07-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with intraperitoneal caesarean section	Caesarean	-
patient with extraperitoneal caesarean section	Caesarean	Faucs technique

Primary Outcome Measures

Name	Time	Method
The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness".	1 month	These criteria are defined in the Chung score. This score is between 0 and 10 and evaluate the vital signs, wandering, nausea or vomits, pain and surgical bleeding.

Trial Locations

Locations (1)

Les Franciscaines Clinic; 🇫🇷 Versailles, IDF, France