Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Eastern Virginia Medical School
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients who enter pregnancy with a diagnosis of type I or type II diabetes mellitus. * Pregnant women between the ages of 18-45 * Live, singleton gestation * Understanding and ability to give informed consent
Exclusion criteria
* Patient unwilling or unable to provide consent * Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians) * Age less than 18 years of age * Multifetal gestation * Chromosomal abnormality * Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19 * Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elevated TcB | June 2023 to June 2025 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Distress | June 2023 to June 2025 | 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 |
| Jaundice | June 2023 to June 2025 | Jaundice requiring phototherapy |
| Hypoglycemia | June 2023 to June 2025 | \<40 mg/dl in the first 24 hours of life |
| Polycythemia | June 2023 to June 2025 | Hematocrit \>65% or hemoglobin \>22 mg/dl |
Countries
United States
Contacts
Primary ContactKristin Ayers, MPH
Outcome results
None listed