Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03405116
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2017-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction Tool for Premature Labour and Neonatal Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2037}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Register', 'timeFrame': '2017 - 2030', 'description': 'A multicentre, multidisciplinary register will be created to provide a source of valuable information on obstetrical and neonatal practices and link them with obstetrical, neonatal and long-term outcomes of preterm labour and birth'}, {'measure': 'Prediction model', 'timeFrame': '2017 - 2030', 'description': 'The prediction tool for true preterm labour (TPL) will be developed using individual risk factors, symptomatology, tocography, cervical change and a biomarker test, followed by a decision-making model, both based on individual data, evidence and experience.'}], 'secondaryOutcomes': [{'measure': 'The interval between starting corticosteroids and delivery', 'timeFrame': '2012-2020', 'description': 'The interval between administration of antenatal corticosteroids and birth will be assessed and will be related to the short and long term outcome of preterm born children'}]}, 'conditionsModule': {'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '32621250', 'type': 'DERIVED', 'citation': 'Dehaene I, Scheire E, Steen J, De Coen K, Decruyenaere J, Smets K, Roelens K. Obstetrical characteristics and neonatal outcome according to aetiology of preterm birth: a cohort study. Arch Gynecol Obstet. 2020 Oct;302(4):861-871. doi: 10.1007/s00404-020-05673-5. Epub 2020 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'A register and prediction model will be developed to predict the outcome of preterm labour and birth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women visiting the maternity ward suffering from symptoms of preterm birth.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children\n\nExclusion Criteria:\n\n* Patients who choose not to participate in the research.\n* Intra-uterine prelabour fetal death.\n* Fetuses or neonates with a major congenital disorder. Major is defined as a disorder that has an impact on neonatal respiratory and cerebral outcome and/or long-term outcome.\n* Postpartum transfer/outborn.'}, 'identificationModule': {'nctId': 'NCT03405116', 'acronym': 'PRETURN', 'briefTitle': 'Prediction Tool for Premature Labour and Neonatal Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Neonatal and Long Term Outcomes of Preterm Born Children in Flanders', 'orgStudyIdInfo': {'id': 'B670201732321 (BC-00466)'}}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': "Ghent University Hospital - Women's Clinic", 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Kristien Roelens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}