Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02596932
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2015-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2015-10-31', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean neonatal blood glucose levels', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Neonatal Intensive Care Unit (NICU) admission', 'timeFrame': 'Birth of neonate until time of discharge of neonate to home up to 7 days', 'description': 'Any admission to Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home'}, {'measure': 'Hours in Neonatal Intensive Care Unit (NICU)', 'timeFrame': 'Birth of neonate until time of discharge of neonate to home up to 7 days', 'description': 'Any time spent in Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home'}, {'measure': 'Maternal hypoglycemia', 'timeFrame': 'Intrapartum period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intrapartum'], 'conditions': ['Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31135731', 'type': 'DERIVED', 'citation': 'Hamel MS, Kanno LM, Has P, Beninati MJ, Rouse DJ, Werner EF. Intrapartum Glucose Management in Women With Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2019 Jun;133(6):1171-1177. doi: 10.1097/AOG.0000000000003257.'}]}, 'descriptionModule': {'briefSummary': 'Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there is a paucity of data guiding practitioners in the intrapartum management of blood glucose levels for women with GDM, particularly those treated with insulin antepartum. The goal of this project is to compare two protocols of intrapartum glucose management in women with GDM and investigate the impact on neonatal blood glucose levels.', 'detailedDescription': 'Research objective- To compare "Tight" vs. "Less Tight" intrapartum glucose management\n\nHypothesis: Neonates born to mothers managed via the "Less Tight" intrapartum glucose management protocol will have lower mean glucose levels in the first 24 hours of life when compared to mean glucose levels among infants born to mothers managed via the "Tight" intrapartum glucose management protocol.\n\nStudy Design: Randomized trial\n\nPopulation: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women \\& Infants Hospital, with a plan to deliver at Women \\& Infants Hospital\n\nOnce enrolled, patients will then be randomized to "Tight" or "Less Tight" intrapartum glucose control.\n\nOnce admitted to the labor floor for intrapartum management the appropriate power plan for glucose control will be initiated. The specifics of labor management will be left to the discretion of the provider.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women \\& Infants Hospital, with a plan to deliver at Women \\& Infants Hospital\n\nExclusion Criteria:\n\n* Pre-existing DM, multiple gestations, major fetal anomalies anticipated to require NICU admission, planned cesarean delivery, medications known to effect glucose metabolism other than insulin (i.e. metformin)'}, 'identificationModule': {'nctId': 'NCT02596932', 'briefTitle': 'Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels', 'orgStudyIdInfo': {'id': '809018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tight control', 'description': 'Intervention Standard Care:\n\nTight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level \\> 100mg/dL or \\< 60 mg/dL', 'interventionNames': ['Other: Standard Protocol for intrapartum glucose management']}, {'type': 'EXPERIMENTAL', 'label': 'Less tight control', 'description': 'Intervention:\n\nLess Tight glucose control protocol: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose \\> 120 mg/dL or \\< 60mg/dL', 'interventionNames': ['Other: Experimental Protocol for intrapartum glucose management']}], 'interventions': [{'name': 'Standard Protocol for intrapartum glucose management', 'type': 'OTHER', 'otherNames': ['Tight Control'], 'description': 'Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level \\> 100mg/dL or \\< 60mg/dL', 'armGroupLabels': ['Tight control']}, {'name': 'Experimental Protocol for intrapartum glucose management', 'type': 'OTHER', 'otherNames': ['Less Tight Control'], 'description': 'Less Tight: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose \\> 120 mg/dL or \\< 60 mg/dL', 'armGroupLabels': ['Less tight control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women & Infants Hospital Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Maureen S Hamel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maternal Fetal Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maureen S. Hamel MD', 'investigatorFullName': 'Maureen Hamel', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}