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

Prospective Multicenter Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Dehiscence; Extra Peritoneal Caesarean Section
• Intervention / Treatment: Procedure: Caesarean

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • IDF
    • Versailles, IDF, France, 78000
      • Recruiting
      • Les Franciscaines Clinic
      • Contact: Bénédicte Simon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Patient with intraperitoneal caesarean section	Procedure: Caesarean; Two different caesarean section techniques : intra or extraperitoneal
EXPERIMENTAL: patient with extraperitoneal caesarean section; Faucs technique	Procedure: Caesarean; Two different caesarean section techniques : intra or extraperitoneal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness".	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.	1 month

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 27, 2021
• Primary Completion (ANTICIPATED): September 27, 2022
• Study Completion (ANTICIPATED): July 27, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (ACTUAL): September 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019-A01220-57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No