Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial

NCT ID: NCT06190405

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Gestational Diabetes; Large for Gestational Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Universal hemoglobin A1c

Patients at \<16 weeks will have a hemoglobin A1c obtained

Group Type: EXPERIMENTAL

Hemoglobin A1c

Intervention Type: DIAGNOSTIC_TEST

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.

Risk-based screening by ACOG with two-step GTT

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.

Group Type: ACTIVE_COMPARATOR

Risk-based screening by ACOG with two-step GTT

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Hemoglobin A1c

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.

Intervention Type: DIAGNOSTIC_TEST

Risk-based screening by ACOG with two-step GTT

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Presenting to prenatal care ≤16 6/7 weeks of gestation
• Intend to deliver at TJUH

Exclusion Criteria

• Multifetal gestation
• Pre-pregnancy diagnosis of diabetes mellitus
• History of malabsorptive gastric bypass surgery
• Hemoglobinopathy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Rodney McLaren, Jr.

Assistant Professor, Obstetrics and Gynecology, Director of MFM Outpatient Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rodney McLaren, MD

Role: CONTACT

rodney.mclaren@jefferson.edu

215-955-5000

Other Identifiers

iRISID-2023-1750

Identifier Type: -

Identifier Source: org_study_id