Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05536869
Status:
UNKNOWN
Last Update Posted:
2022-09-15
First Post:
2022-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean (FAUCS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-07-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness".', 'timeFrame': '1 month', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section; Dehiscence', 'Extra Peritoneal Caesarean Section']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient scheduled for a caesarean between 38 and 42 weeks pregnant\n* Patient aged between 18 and 42 years old\n* Singleton\n* Caesarean section with a theoretical operating time \\< 1 hour (without major complications)\n* Patient affiliated to a social security scheme\n* Patient having signed the free and informed consent.\n\nExclusion Criteria:\n\n* BMI \\> 40\n* High blood pressure treated intravenously\n* Pre-existing diabetes in pregnancy\n* Allergy to analgesics\n* Prenatal depression\n* Pathological insertion of the placenta (placenta previa or accreta).\n* History of major pelvic or abdominal surgery (myomectomy, peritonitis) other than caesarean section or minor surgery.\n* Addiction (drugs)\n* Pre-existing psychiatric pathology leading to a risk of impaired judgment or behavior.\n* Patient participating in another clinical study with a drug or medical device\n* Protected patient: Adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision\n* Patient hospitalized without consent.'}, 'identificationModule': {'nctId': 'NCT05536869', 'acronym': 'FAUCS', 'briefTitle': 'Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean (FAUCS)', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Prospective Multicenter Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean', 'orgStudyIdInfo': {'id': '2019-A01220-57'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patient with intraperitoneal caesarean section', 'interventionNames': ['Procedure: Caesarean']}, {'type': 'EXPERIMENTAL', 'label': 'patient with extraperitoneal caesarean section', 'description': 'Faucs technique', 'interventionNames': ['Procedure: Caesarean']}], 'interventions': [{'name': 'Caesarean', 'type': 'PROCEDURE', 'description': 'Two different caesarean section techniques : intra or extraperitoneal', 'armGroupLabels': ['Patient with intraperitoneal caesarean section', 'patient with extraperitoneal caesarean section']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000', 'city': 'Versailles', 'state': 'IDF', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bénédicte Simon', 'role': 'CONTACT'}], 'facility': 'Les Franciscaines Clinic', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}], 'centralContacts': [{'name': 'Jean-François Oudet', 'role': 'CONTACT', 'email': 'jf.oudet@ecten.eu', 'phone': '0683346567'}, {'name': 'Marie-Hélène Barba', 'role': 'CONTACT', 'email': 'mh.barba@ecten.eu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Trial Experts Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}