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

Not Applicable

Not yet recruiting

• Conditions: Gestational Diabetes; Large for Gestational Age
• Interventions: Diagnostic Test: Hemoglobin A1c; Diagnostic Test: Risk-based screening by ACOG with two-step GTT

• Registration Number: NCT06190405
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study Start: 2024-01
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 770

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Universal hemoglobin A1c	Hemoglobin A1c	Patients at \<16 weeks will have a hemoglobin A1c obtained
Risk-based screening by ACOG with two-step GTT	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.

Primary Outcome Measures

Name	Time	Method
Large-for-gestational age	At time of delivery	Birthweight ≥90th percentile

Secondary Outcome Measures

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