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

NCT06190405 | Unknown

• 1 other identifier: iRISID-2023-1750
• Study Type: interventional
• Target: 770
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Large-for-gestational age

  Birthweight ≥90th percentile

  At time of delivery

Secondary Outcomes (11)

• Preterm birth

  At time of delivery

• Stillbirth

  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

Study Arms (2)

Universal hemoglobin A1c

EXPERIMENTAL

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

Diagnostic Test: Hemoglobin A1c

Risk-based screening by ACOG with two-step GTT

ACTIVE COMPARATOR

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

Interventions

Hemoglobin A1c 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.

Universal hemoglobin A1c

Risk-based screening by ACOG with two-step GTT 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.

Risk-based screening by ACOG with two-step GTT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Rodney McLaren, MD

CONTACT

215-955-5000; rodney.mclaren@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics and Gynecology, Director of MFM Outpatient Care

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2023-12