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The goal of our study is to identify ultrasonographic markers that can predict adverse neonatal outcomes. Specifically, we hypothesize that an increase in fetal liver volumes will increase transcutaneous bilirubin (TcB) in the newborn and thus jaundice requiring phototherapy. This information can be used in patient counseling and to guide future screening protocols for ultrasound in individuals with diabetes.
This is a single center, prospective case control study. Cases will be collected prospectively and control subjects will be data collected retrospectively from the reference population of the human placenta project (IRB #15-09-FB-0179). If patients agree to participate, one ultrasound will be performed at 30-34 weeks' gestation to look at the fetal parameters as described below. It is standard of care for all patients with pregestational diabetes to receive growth ultrasounds throughout their pregnancy. Patients who are diagnosed with pregestational diabetes at EVMS routinely undergo an ultrasound at 30-34 weeks' gestation. Therefore, ultrasound data will be collected during their scheduled 30-34 week ultrasound visit and no additional ultrasounds will need to be performed. At the time of enrollment, the PI or other study collaborator will ensure that the patient has previously had a detailed ultrasound evaluation (Code 76811). These patients will then be followed prospectively until delivery. The neonates of the study patients will be followed via chart review after delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Criteria for inclusion of subjects
Criteria for exclusion of subjects
| ||
| Controls | The control group will be a referent population of the Human Placenta Project. This reference population consists of patients who meet the following criteria: Maternal:
Fetal- Newborn Outcomes:
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| Measure | Description | Time Frame |
|---|---|---|
| Elevated TcB | The primary objective of this study is to identify if increased fetal liver volumes correlate with elevated transcutaneous bilirubin (TcB) in neonates of mothers with diabetes. | June 2023 to June 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Distress | One or more signs of increased work of breathing, such as tachypnea with a respiratory rate > 60 breaths per minute, nasal flaring, chest retractions, or grunting [13] requiring oxygen support | June 2023 to June 2025 |
| Jaundice |
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Inclusion Criteria:
Exclusion Criteria:
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We plan to recruit 52 individuals with diabetes and 104 control subjects from the reference population of the human placenta project (IRB #15-09-FB-0179).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Ayers, MPH | Contact | 7574460579 | ayerskl@evms.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School | Recruiting | Norfolk | Virginia | 23507 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Jaundice requiring phototherapy |
| June 2023 to June 2025 |
| Hypoglycemia | <40 mg/dl in the first 24 hours of life | June 2023 to June 2025 |
| Polycythemia | Hematocrit >65% or hemoglobin >22 mg/dl | June 2023 to June 2025 |