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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Diabetes; Large for Gestational Age
• Intervention / Treatment: Diagnostic test: Hemoglobin A1c; Diagnostic test: Risk-based screening by ACOG with two-step GTT

• Study Type: Interventional
• Enrollment (Estimated): 770
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodney McLaren, MD; Phone Number: 215-955-5000; Email: rodney.mclaren@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Universal hemoglobin A1c; Patients at <16 weeks will have a hemoglobin A1c obtained	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Large-for-gestational age	Birthweight ≥90th percentile	At time of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth		At time of delivery
Stillbirth	Fetal death prior to delivery	At time of delivery
Shoulder dystocia		At time of delivery
Birth injury		At time of delivery
Neonatal hypoglycemia		From 0 to 24 hours after birth
Neonatal death	Neonatal death within 28 days of birth	28 days after birth
Rate of early GDM diagnosis		At time of delivery
Rate of GDM diagnosis after 24 weeks		At time of delivery
Rate of pregestational diabetes		At time of delivery
Rate of patients requiring medication	Patients requiring oral hypoglycemic medication and/or insulin treatment	At time of delivery
Rate of hypertensive disorders of pregnancy	Gestational hypertension and/or preeclampsia	At time of delivery

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: iRISID-2023-1750

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No