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

Cesarean Section; Dehiscence Clinical Trial

— FAUCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536869
• Other study ID #: 2019-A01220-57
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2021
• Est. completion date: July 27, 2023

Study information

• Verified date: September 2022
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 27, 2023
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence

Intervention

Procedure:
• Caesarean
Two different caesarean section techniques : intra or extraperitoneal

Locations

Country	Name	City	State
France	Les Franciscaines Clinic	Versailles	IDF

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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