Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:21 AM
Study NCT ID:
NCT04792112
Status:
UNKNOWN
Last Update Posted:
2022-06-02
First Post:
2021-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigating the Grey Zone for Antenatal Corticosteroids
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Controlled before and after study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in frequency of clinical counselling about late preterm antenatal corticosteroids.', 'timeFrame': 'up to 8 months following implementation of the intervention.', 'description': "The difference in the proportion of patients who delivered a neonate at 34+0 to 36+6 weeks' gestation who report having had a discussion about antenatal corticosteroids with their care provider pre-intervention versus post-intervention."}], 'secondaryOutcomes': [{'measure': 'The change in quality of clinical counselling about late preterm antenatal corticosteroids as assessed by the COMRADE scale.', 'timeFrame': 'up to 8 months following implementation of the intervention.', 'description': 'The difference in the average median score on the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) scale, among those that report having had a discussion about late preterm antenatal corticosteroids with their health care provider. We will use an adapted scale including 19 items, each of which are scored on a 5-point Likert scale. A higher score indicates better risk communication and treatment decision making effectiveness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antenatal corticosteroid'], 'conditions': ['Decision Making, Shared', 'Pregnancy', 'Preterm Birth']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if including a decision support tool in clinical practice guidelines will improve how doctors discuss the option of antenatal corticosteroid treatment with patients who might deliver at 34 to 36 weeks of pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 year or older.\n* Delivered a live neonate at 34+0 to 36+6 weeks of gestation.\n* Speaks English.\n* Agrees to participate in the questionnaire during their first week post-partum.\n* Delivered at one of the six participating obstetrical hospitals.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT04792112', 'briefTitle': 'Navigating the Grey Zone for Antenatal Corticosteroids', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Improving Clinical Practice Guidelines for Antenatal Corticosteroids: Incorporating a Decision Support Tool to Tackle the Uncertain Balance of Harms and Benefits', 'orgStudyIdInfo': {'id': 'H20-03071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guideline + decision support tool', 'description': 'A decision support tool summarizing harms and benefits of late preterm antenatal corticosteroids will be integrated into the clinical practice guideline available to clinicians in the hospitals in the experimental arm.', 'interventionNames': ['Behavioral: Decision support tool']}, {'type': 'NO_INTERVENTION', 'label': 'Guideline only', 'description': "Clinicians in the hospitals in the 'no-intervention' arm will have access to the standard guideline only (without the integrated decision support tool)."}], 'interventions': [{'name': 'Decision support tool', 'type': 'BEHAVIORAL', 'description': 'Decision support tool for late preterm antenatal corticosteroids', 'armGroupLabels': ['Guideline + decision support tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jason Burrows', 'role': 'CONTACT'}, {'name': 'Jason Burrows, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Surrey Memorial Hospital', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jessica Liauw, MD', 'role': 'CONTACT', 'email': 'jessica.liauw@phsa.ca', 'phone': '604-875-2424', 'phoneExt': '5779'}], 'facility': "BC Women's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Jessica Liauw, MD', 'role': 'CONTACT', 'email': 'jessica.liauw@phsa.ca', 'phone': '604-875-2424', 'phoneExt': '5779'}], 'overallOfficials': [{'name': 'Jessica Liauw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Jessica Liauw', 'investigatorAffiliation': 'University of British Columbia'}}}}