Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT03702959
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2018-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001623', 'term': 'Betamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of neonatal hypoglycemia', 'timeFrame': '7 years', 'description': 'Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'A single "supraphysiological" course of exogenous corticosteroids is recommended between 24-34 weeks\' gestation to minimize the adverse sequelae associated with prematurity. The 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.', 'detailedDescription': "A retrospective study from January 2010 to December 2017. Eligible for analysis are: singleton pregnancies between 24 - 34 weeks' gestation who were given a single course of intramuscular betamethasone. Single course comprised of two separate doses of 12 mg given 24 hours apart. Each woman was allocated into one of the four pre-defined groups based on the time the intramuscular betamethasone was administered; Group 1 (5am-11am), group 2 (11am-5pm), group 3 (5pm-11pm) and group 4 (11pm-5am). The investigators hypothesized that exogenous corticosteroids given during the nadir state of endogenous corticosteroids activity could alter maternal and fetal glucose homeostasis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective study at Rambam Health Care Campus.', 'genderDescription': 'Pregnant women and their newborns', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n• women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution\n\nExclusion Criteria:\n\n* higher order multiple pregnancies\n* women who were given more than one course of betamethasone during the course of the current pregnancy\n* known major congenital anomalies."}, 'identificationModule': {'nctId': 'NCT03702959', 'briefTitle': 'Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': "Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing", 'orgStudyIdInfo': {'id': '0205 - 18 - RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Betamethasone group 1', 'description': 'Betamethasone Group 1 (5am-11am)', 'interventionNames': ['Drug: Betamethasone']}, {'label': 'Betamethasone Group 2', 'description': 'Betamethasone Group 2 (11am-5pm)', 'interventionNames': ['Drug: Betamethasone']}, {'label': 'Betamethasone Group 3', 'description': 'Betamethasone Group 3 (5pm-11pm)', 'interventionNames': ['Drug: Betamethasone']}, {'label': 'Betamethasone Group 4', 'description': 'Betamethasone Group 4 (11pm-5am).', 'interventionNames': ['Drug: Betamethasone']}], 'interventions': [{'name': 'Betamethasone', 'type': 'DRUG', 'description': 'Corticosteroids', 'armGroupLabels': ['Betamethasone Group 2', 'Betamethasone Group 3', 'Betamethasone Group 4', 'Betamethasone group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Yaniv Zipori, M.D', 'role': 'CONTACT', 'email': 'y_zipori@rambam.health.gov.il', 'phone': '+972 58 7966963'}], 'overallOfficials': [{'name': 'Yaniv Zipori, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The study is expected to be published after completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yaniv Zipori MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}