NCT06190405

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-01-05
• Last updated: 2024-01-05