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

Gestational Diabetes Clinical Trial

— EARLYGDM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06190405
• Other study ID #: iRISID-2023-1750
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Thomas Jefferson University
• Contact: Rodney McLaren, MD
• Phone: 215-955-5000
• Email: rodney.mclaren[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 770
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Large-for-gestational age	Birthweight =90th percentile	At time of delivery
Secondary	Preterm birth		At time of delivery
Secondary	Stillbirth	Fetal death prior to delivery	At time of delivery
Secondary	Shoulder dystocia		At time of delivery
Secondary	Birth injury		At time of delivery
Secondary	Neonatal hypoglycemia		From 0 to 24 hours after birth
Secondary	Neonatal death	Neonatal death within 28 days of birth	28 days after birth
Secondary	Rate of early GDM diagnosis		At time of delivery
Secondary	Rate of GDM diagnosis after 24 weeks		At time of delivery
Secondary	Rate of pregestational diabetes		At time of delivery
Secondary	Rate of patients requiring medication	Patients requiring oral hypoglycemic medication and/or insulin treatment	At time of delivery
Secondary	Rate of hypertensive disorders of pregnancy	Gestational hypertension and/or preeclampsia	At time of delivery