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Clinical Trials/NCT06190405
NCT06190405Not yet recruitingNot Applicable

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

Thomas Jefferson University0 sites770 target enrollmentStarted: January 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
770
Primary Endpoint
Large-for-gestational age
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Large-for-gestational age

Time Frame: At time of delivery

Birthweight ≥90th percentile

Secondary Outcomes

  • Birth injury(At time of delivery)
  • Neonatal death(28 days after birth)
  • Rate of early GDM diagnosis(At time of delivery)
  • Rate of pregestational diabetes(At time of delivery)
  • Neonatal hypoglycemia(From 0 to 24 hours after birth)
  • Rate of hypertensive disorders of pregnancy(At time of delivery)
  • Stillbirth(At time of delivery)
  • Rate of patients requiring medication(At time of delivery)
  • Preterm birth(At time of delivery)
  • Shoulder dystocia(At time of delivery)
  • Rate of GDM diagnosis after 24 weeks(At time of delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rodney McLaren, Jr.

Assistant Professor, Obstetrics and Gynecology, Director of MFM Outpatient Care

Thomas Jefferson University

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Universal Hemoglobin A1c Versus Risk-based... | Clinical Trial