Gestational Diabetes, Large for Gestational Age
Conditions
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.
Interventions
DIAGNOSTIC_TESTHemoglobin 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.
DIAGNOSTIC_TESTRisk-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.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Large-for-gestational age | At time of delivery | Birthweight ≥90th percentile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stillbirth | At time of delivery | Fetal death prior to delivery |
| Shoulder dystocia | At time of delivery | — |
| Birth injury | At time of delivery | — |
| Neonatal hypoglycemia | From 0 to 24 hours after birth | — |
| Neonatal death | 28 days after birth | Neonatal death within 28 days of birth |
| Preterm birth | At time of delivery | — |
| Rate of GDM diagnosis after 24 weeks | At time of delivery | — |
| Rate of pregestational diabetes | At time of delivery | — |
| 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 |
| Rate of early GDM diagnosis | At time of delivery | — |
Contacts
Primary ContactRodney McLaren, MD
Outcome results
None listed