Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT05779735
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-10-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cesarean delivery rate', 'timeFrame': 'baseline', 'description': 'Demonstrate that the angle of progression measurement would change by 20% the cesarean rate after a prolonged second stage of labor (2 hours).'}], 'secondaryOutcomes': [{'measure': 'Number of complicated deliveries in each group', 'timeFrame': 'baseline', 'description': "A complicated deliveries is defined by the occurrence of at least one of the following events :\n\n* Failed instrumental extraction\n* Sequential use of a second instrument,\n* Difficult instrumental extraction defined as :\n\n * vacuum detachment\n * requires the use of a second instrument,\n * extraction time \\> 10 minutes,\n * operator's impression of the difficulty of extraction,\n* Shoulder dystocia by obstetric maneuver"}, {'measure': 'Severe maternal morbidity, in each group', 'timeFrame': '1 month', 'description': 'Severe maternal morbidity is defined by the occurrence of at least one of the following events:\n\n* postpartum hemorrhage requiring hysterectomy, embolization, conservative surgical treatment or blood transfusion,\n* third or fourth degree perineal tears\n* vaginal thrombus,\n* cervical tear,\n* surgical wounds\n* sepsis, amniotic embolism, cardiac complication or renal failure.'}, {'measure': 'Severe neonatal morbidity, in each group', 'timeFrame': '1 month', 'description': 'Severe neonatal morbidity, in each group, defined by the occurrence of at least one event below:\n\n* severe biological signs\n* moderate or absent biological signs but associated with perinatal events\n* seizure\n* severe neonatal trauma\n* Fetal death or neonatal death.'}, {'measure': 'Rate of admission to neonatal intensive care unit, in each group', 'timeFrame': '1 month', 'description': 'Number of newborns admitted to intensive care out of the total number of newborns'}, {'measure': 'Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading', 'timeFrame': '1 month', 'description': 'Centralized blind AOP measurement reading'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['angle of progression', 'cesarean delivery', 'transperineal ultrasound'], 'conditions': ['Prolonged Second Stage of Labor']}, 'descriptionModule': {'briefSummary': 'Ultrasound during labor and measurement of Angle of progression showed extensive prospective and retrospective publications since 2010. The investigators performed between 2013 and 2016 the only one multicenter, randomized controlled Trial comparing digital exam to angle of progression after a prolonged 2-hour second stage of labor with uncertain fetal head. The investigators consider a cut off of 120° to accepted vaginal birth among cephalic occiput anterior position This randomised PILOT study showed that measurement of Angle of progression in addition to digital exam reduced caesarean delivery from 41% to12% ( n= 33, p=0,06). doi: 10.1016/j.ajog.2022.04.018.\n\nThe objective of this new study is therefore to validate the results of this PILOT study in a more powerful multicenter randomized trial (DELIVERY).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous or multiparous women with no history of vaginal delivery,\n* \\> or = 37 weeks amenorrhoea\n* Cephalic presentation in anterior position (occipito-pubic position, left anterior occipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound\n* uncertain fetal head engagement on digital examination or midline fetal presentation in prolonged second stage of labor (at least 2 hours),\n\nExclusion Criteria:\n\n* Multiparous women who were previous vaginal deliveries,\n* Presentation other than cephalic,\n* Twin pregnancies,\n* Posterior or transverse position\n* Transperineal ultrasound for head-perineum distance measurement\n* Fetal heart rate abnormalities requiring rapid delivery,\n* Contraindication to vaginal delivery whether maternal or fetal'}, 'identificationModule': {'nctId': 'NCT05779735', 'acronym': 'DELIVERY', 'briefTitle': 'Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate', 'organization': {'class': 'OTHER', 'fullName': 'Hospital St. Joseph, Marseille, France'}, 'officialTitle': 'Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.', 'orgStudyIdInfo': {'id': '2022-A01978-35 DELIVERY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1 : control', 'description': 'The mode of delivery will be determined by clinical examens (digital examination)'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 : Transperineal ultrasound measurements of AOP', 'description': 'The mode of delivery will be determined by clinical examens (digital examination) and ultrasound measurement of the AOP :\n\n* vaginal delivery is encouraged if AOP measurement is \\>120°\n* cesarean delivery is encouraged if AOP measurement is \\<= 120°', 'interventionNames': ['Diagnostic Test: Transperineal ultrasound measurements of AOP']}], 'interventions': [{'name': 'Transperineal ultrasound measurements of AOP', 'type': 'DIAGNOSTIC_TEST', 'description': 'The angle of progression (AOP) defined as the angle between the pubic bone axis and the leading part of the fetal head', 'armGroupLabels': ['Group 2 : Transperineal ultrasound measurements of AOP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles GARABEDIAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Lille - Hôpital Jeanne de Flandre', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence Bretelle', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHM Hôpital Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13008', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rahamia AHAMADA', 'role': 'CONTACT'}, {'name': 'Jean-Baptiste Haumonte', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13015', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Castel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHM Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne PINTON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Armand Trousseau AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '78300', 'city': 'Poissy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibaud QUIBEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHIC Poissy', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'zip': '83000', 'city': 'Toulon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franck MAUVIEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHITS Hôpital Sainte Musse', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'centralContacts': [{'name': 'Rahamia Ahamada', 'role': 'CONTACT', 'email': 'rahamada@hopital-saint-joseph.fr', 'phone': '0033488731071'}], 'overallOfficials': [{'name': 'Jean-Baptiste Haumonte', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Saint Joseph Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital St. Joseph, Marseille, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}