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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Universal hemoglobin A1c | Experimental | Patients at <16 weeks will have a hemoglobin A1c obtained |
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| Risk-based screening by ACOG with two-step GTT | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoglobin A1c | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Large-for-gestational age | Birthweight ≥90th percentile | At time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth | At time of delivery | |
| Stillbirth | Fetal death prior to delivery | At time of delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodney McLaren, MD | Contact | 215-955-5000 | rodney.mclaren@jefferson.edu |
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| Risk-based screening by ACOG with two-step GTT | Diagnostic Test | 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. |
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| Shoulder dystocia |
| At time of delivery |
| Birth injury | At time of delivery |
| Neonatal hypoglycemia | From 0 to 24 hours after birth |
| Neonatal death | Neonatal death within 28 days of birth | 28 days after birth |
| Rate of early GDM diagnosis | 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 | Patients requiring oral hypoglycemic medication and/or insulin treatment | At time of delivery |
| Rate of hypertensive disorders of pregnancy | Gestational hypertension and/or preeclampsia | At time of delivery |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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