Cesarean Section; DehiscenceFAUCSNCT05536869
Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean (FAUCS)
A study testing Caesarean in people with Cesarean Section; Dehiscence and Extra Peritoneal Caesarean Section, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence, Extra Peritoneal Caesarean Section
- What is being tested?
- Caesarean
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 27 Dec 2021to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Les Franciscaines Clinic
Versailles, IDF, 78000
Bénédicte Simon
About this study
Official title: 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.
- Being tested
- Caesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaesareanProcedure or surgery
Two different caesarean section techniques : intra or extraperitoneal
| Study group | Role | What they receive |
|---|---|---|
| Patient with intraperitoneal caesarean section | Active comparator | Not described Receives: Procedure: Caesarean |
| patient with extraperitoneal caesarean section | Experimental | Faucs technique Receives: Procedure: Caesarean |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start27 Dec 2021
- Primary completion27 Sep 2022 (estimated)
- Study completion27 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536869
- Sponsor's protocol ID
- 2019-A01220-57
- Acronym
- FAUCS
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean
- ClinicalTrials.gov ID
- NCT05536869
- Acronym / sponsor ID
- FAUCS / 2019-A01220-57
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 27 Sep 2022 (estimated)
- Study completion
- 27 Jul 2023 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with intraperitoneal caesarean section | Active comparator | Procedure: Caesarean |
| patient with extraperitoneal caesarean section | Experimental | Procedure: CaesareanFaucs technique |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- BMI > 40
- High blood pressure treated intravenously
- Pre-existing diabetes in pregnancy
- Allergy to analgesics
- Prenatal depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaesareanTwo different caesarean section techniques : intra or extraperitoneal | Procedure or surgery | Patient with intraperitoneal caesarean section, patient with extraperitoneal caesarean section |
Primary outcome
The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness".
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caesarean in people with Cesarean Section; Dehiscence and Extra Peritoneal Caesarean Section, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness". (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.