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
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 27, 2021
CompletedFirst Submitted
Initial submission to the registry
September 8, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedSeptember 15, 2022
September 1, 2022
9 months
September 8, 2022
September 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Patient with intraperitoneal caesarean section
ACTIVE COMPARATORpatient with extraperitoneal caesarean section
EXPERIMENTALFaucs technique
Interventions
Two different caesarean section techniques : intra or extraperitoneal
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- European Clinical Trial Experts Networkcollaborator
Study Sites (1)
Les Franciscaines Clinic
Versailles, IDF, 78000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2022
First Posted
September 13, 2022
Study Start
December 27, 2021
Primary Completion
September 27, 2022
Study Completion
July 27, 2023
Last Updated
September 15, 2022
Record last verified: 2022-09