Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06190405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 770}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Large-for-gestational age', 'timeFrame': 'At time of delivery', 'description': 'Birthweight ≥90th percentile'}], 'secondaryOutcomes': [{'measure': 'Preterm birth', 'timeFrame': 'At time of delivery'}, {'measure': 'Stillbirth', 'timeFrame': 'At time of delivery', 'description': 'Fetal death prior to delivery'}, {'measure': 'Shoulder dystocia', 'timeFrame': 'At time of delivery'}, {'measure': 'Birth injury', 'timeFrame': 'At time of delivery'}, {'measure': 'Neonatal hypoglycemia', 'timeFrame': 'From 0 to 24 hours after birth'}, {'measure': 'Neonatal death', 'timeFrame': '28 days after birth', 'description': 'Neonatal death within 28 days of birth'}, {'measure': 'Rate of early GDM diagnosis', 'timeFrame': 'At time of delivery'}, {'measure': 'Rate of GDM diagnosis after 24 weeks', 'timeFrame': 'At time of delivery'}, {'measure': 'Rate of pregestational diabetes', 'timeFrame': 'At time of delivery'}, {'measure': 'Rate of patients requiring medication', 'timeFrame': 'At time of delivery', 'description': 'Patients requiring oral hypoglycemic medication and/or insulin treatment'}, {'measure': 'Rate of hypertensive disorders of pregnancy', 'timeFrame': 'At time of delivery', 'description': 'Gestational hypertension and/or preeclampsia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes', 'Large for Gestational Age']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at \\<16 weeks 6 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to prenatal care ≤16 6/7 weeks of gestation\n* Intend to deliver at TJUH\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Pre-pregnancy diagnosis of diabetes mellitus\n* History of malabsorptive gastric bypass surgery\n* Hemoglobinopathy'}, 'identificationModule': {'nctId': 'NCT06190405', 'acronym': 'EARLYGDM', 'briefTitle': 'Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'iRISID-2023-1750'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Universal hemoglobin A1c', 'description': 'Patients at \\<16 weeks will have a hemoglobin A1c obtained', 'interventionNames': ['Diagnostic Test: Hemoglobin A1c']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Risk-based screening by ACOG with two-step GTT', 'description': 'Patients at \\<16 weeks will be assessed for risk factors for diabetes as described by ACOG. If patients meet criteria, they will be screened with two-step screening for gestational diabetes. If patients do not meet criteria, they will not be screened until the routine timing of screening for gestational diabetes.', 'interventionNames': ['Diagnostic Test: Risk-based screening by ACOG with two-step GTT']}], 'interventions': [{'name': 'Hemoglobin A1c', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with a HbA1c \\<5.7% will be considered a normal test, and they will continue their routine prenatal care, including GDM screening at 24-28 weeks. Patients with a HbA1c ≥5.7% and ≤6.4% will be diagnosed with early GDM. Patients with a HbA1c ≥6.5% will be diagnosed with pregestational diabetes. Patient diagnosed with early GDM or pregestational diabetes will be treated as per usual clinical protocol for gestational/pregestational diabetes.', 'armGroupLabels': ['Universal hemoglobin A1c']}, {'name': 'Risk-based screening by ACOG with two-step GTT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will be assessed for risk factors for GDM as per ACOG. Patients with a negative screen will continue routine care, including GDM screening at 24-28 weeks. Patients with a positive screen will undergo a two-step GTT screening. Patients with a 1-h GTT \\<135 mg/dL will continue with routine care, including GDM screening at 24-28 weeks. Patients with a 1-h GTT ≥185 mg/dL and \\<200 mg/dL will be diagnosed with early GDM. Patients with a 1-h GTT ≥200 mg/dL will be diagnosed with pregestational DM. Patients with a 1-h GTT ≥135 mg/dL and \\<185 mg/dL will undergo a fasting 3-h GTT. Patient will be diagnosed with early GDM by Carpenter and Coustan criteria. Patients will be diagnosed with pregestational DM if their fasting glucose value is ≥126 mg/dL. If patients pass the 3-h GTT, they will continue routine care, including GDM screen at 24-28 weeks with a 3-h GTT. Patient diagnosed with early GDM/pregestational DM will be treated as per usual clinical protocol for GDM/pregestational DM.', 'armGroupLabels': ['Risk-based screening by ACOG with two-step GTT']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rodney McLaren, MD', 'role': 'CONTACT', 'email': 'rodney.mclaren@jefferson.edu', 'phone': '215-955-5000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Obstetrics and Gynecology, Director of MFM Outpatient Care', 'investigatorFullName': 'Rodney McLaren, Jr.', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}