Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-24 @ 3:26 PM
Study NCT ID:
NCT02570620
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2015-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2015-10-02', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in hours between induction of prostaglandins and delivery', 'timeFrame': 'On the day of inclusion after induction of prostaglandins. In relation to the time of delivery.', 'description': 'Delivery whether a vaginal delivery or cesarean'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Delivery Uterine', 'Birth; Induced']}, 'descriptionModule': {'briefSummary': 'Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Single pregnancy to term (\\> 37 weeks) in cephalic presentation\n* Bishop score on the day of inclusion equal to 4.5 or 6\n* Medical indication in accordance with professional recommendations of the April 2008 HAS.\n\nExclusion Criteria:\n\n* Cicatricial uterus\n* Placenta previa\n* Parity \\> 3 (more than 3 previous deliveries \\> 22 weeks)\n* History of cone biopsy and strapping\n* Known fetal malformation\n* Known allergy to prostaglandins\n* Woman under guardianship'}, 'identificationModule': {'nctId': 'NCT02570620', 'acronym': 'ECOLDIA', 'briefTitle': 'Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': "Apport de l'échographie du Col Dans l'évaluation du Délai Induction Accouchement (DIA) Chez Des Patientes à Score de Bishop défavorable après déclenchement Par Dinoprostone Intravaginal", 'orgStudyIdInfo': {'id': 'PHRI09-JP/ECOLDIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Observational cohort of patients', 'description': 'Patients will benefit from an ultrasonography of the cervix through endovaginal before induction of prostaglandins', 'interventionNames': ['Device: Ultrasonography of the cervix']}], 'interventions': [{'name': 'Ultrasonography of the cervix', 'type': 'DEVICE', 'armGroupLabels': ['Observational cohort of patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'University Hospital of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Orléans', 'country': 'France', 'facility': 'Hospital of Orleans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Tours', 'country': 'France', 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Jérôme POTIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}