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

Thomas Jefferson University

Status: Not yet enrolling

Conditions: Gestational Diabetes; Large for Gestational Age

Treatments: Diagnostic Test: Hemoglobin A1c; Diagnostic Test: Risk-based screening by ACOG with two-step GTT

Study type: Interventional

Funder types: Other

Identifiers

NCT06190405

iRISID-2023-1750

Details and patient eligibility

About

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.

Enrollment: 770 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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770 participants in 2 patient groups

Universal hemoglobin A1c

Experimental group

Description:

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

Treatment:

Diagnostic Test: Hemoglobin A1c

Risk-based screening by ACOG with two-step GTT

Active Comparator group

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.

Treatment:

Diagnostic Test: Risk-based screening by ACOG with two-step GTT