Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04332393
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2020-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin to Treat Corticosteroids-induced Hyperglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2020-03-29', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean maternal daily glucose values', 'timeFrame': 'Up to 4 days', 'description': 'According to daily glucose charts'}, {'measure': 'The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks)', 'timeFrame': 'Up to 7 days after delivery or discharge (which ever comes first)'}], 'secondaryOutcomes': [{'measure': 'Mean maternal daily pre-prandial glucose values', 'timeFrame': 'Up to 4 days', 'description': 'According to daily glucose charts'}, {'measure': 'Mean maternal daily post-prandial glucose values', 'timeFrame': 'Up to 4 days', 'description': 'According to daily glucose charts'}, {'measure': 'Percent of abnormal values in the daily glucose chart', 'timeFrame': 'Up to 4 days', 'description': 'According to daily glucose charts'}, {'measure': 'Rate of cesarean sections and operative deliveries', 'timeFrame': 'At delivery'}, {'measure': 'Rate of neonates who will be admitted to the neonatal intensive care unit', 'timeFrame': 'Up to a week after delivery', 'description': 'APGAR scale of 0-worst and 10-best'}, {'measure': 'Apgar score at 1 and 5 minutes', 'timeFrame': 'At delivery'}, {'measure': 'Cord blood pH levels (when taken)', 'timeFrame': 'At delivery'}, {'measure': 'The rate of neonates with hyperbilirubinemia', 'timeFrame': 'Up to 7 days after delivery or discharge (which ever comes first)'}, {'measure': 'Neonatal mean head circumference', 'timeFrame': 'Up to 7 days after delivery or discharge (which ever comes first)'}, {'measure': 'Neonatal mean birth weight', 'timeFrame': 'at delivery'}, {'measure': 'The rate of fetal malformations and developmental disorders', 'timeFrame': 'Up to 7 days after delivery or discharge (which ever comes first)'}, {'measure': 'Mean and lowest neonatal blood glucose values in preterm neonates', 'timeFrame': 'Up to 7 days after delivery or discharge (which ever comes first)'}, {'measure': 'The rate of maternal adverse effects', 'timeFrame': '48 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Preterm', 'Glycemic Control', 'Corticosteroids Induced Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes.\n\nAlthough antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates.\n\nIn the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women receiving betamethasone from 24 to 36.5 gestational weeks\n* Before or within 24 hours following the first dose of betamethasone\n* ≥18 years old\n\nExclusion Criteria:\n\n* Women with pre-gestational and gestational diabetes mellitus (GDM)\n* Known allergic sensitivity to metformin\n* Known chronic heart failure\n* Known chronic renal failure\n* Refuse to participate\n* Refuse to perform glucose challenge test/glucose tolerance test later on'}, 'identificationModule': {'nctId': 'NCT04332393', 'briefTitle': 'Metformin to Treat Corticosteroids-induced Hyperglycemia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Baruch Padeh Medical Center, Poriya'}, 'officialTitle': 'The Effect of Metformin in Pregnant Women Who Received Antenatal Corticosteroids on Glycemic Control and the Rate of Neonatal Hypoglycemia - Multicenter Prospective Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '21-20POR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'metformin group', 'interventionNames': ['Drug: Metformin']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment group'}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 1700 mg around 22:00. Modifications may take place according to glycemic control', 'armGroupLabels': ['metformin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15208', 'city': 'Tiberias', 'state': 'North', 'country': 'Israel', 'facility': 'Baruch Padeh Medical center, Poriya', 'geoPoint': {'lat': 32.79221, 'lon': 35.53124}}, {'city': 'Afula', 'country': 'Israel', 'facility': 'Emek medical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Nahariya', 'country': 'Israel', 'facility': 'Galilee medical center', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'city': 'Safed', 'country': 'Israel', 'facility': 'Ziv medical center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD will be shared according to the local review board regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Baruch Padeh Medical Center, Poriya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}