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 DiabetesLarge for Gestational Age
- 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
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
- 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 hypertensive disorders of pregnancy At time of delivery Gestational hypertension and/or preeclampsia
Stillbirth At time of delivery Fetal death prior to delivery
Rate of patients requiring medication At time of delivery Patients requiring oral hypoglycemic medication and/or insulin treatment
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link elevated hemoglobin A1c to gestational diabetes mellitus in early pregnancy?
How does universal A1c screening compare to risk-based GTT in predicting large-for-gestational-age neonates for GDM management?
Which biomarkers are most predictive of gestational diabetes risk in pregnancies under 16 weeks 6 days?
What adverse events are associated with early glucose tolerance testing in pregnancy and how are they managed?
Are there combination approaches or alternative therapies being explored alongside hemoglobin A1c for early GDM detection?