Ultrasound Findings in Diabetic Pregnancies

This study is looking at how ultrasound pictures of a baby's liver might help predict if newborns of mothers with diabetes will develop jaundice (yellowing of the skin) that needs treatment. Researchers believe that a larger fetal liver (the baby's liver before birth) might lead to higher transcutaneous bilirubin (TcB) levels, which is a measure of jaundice, in the baby after birth. This information could help doctors better advise parents and plan for care. You may be able to join if you are a pregnant woman between 18 and 45 years old with type 1 or type 2 diabetes, carrying one baby, and can give informed consent. The study aims to enroll 156 participants. The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It is a single-center study, and aims to include 156 participants.
What's involved
If you agree to participate, one ultrasound will be performed between 30-34 weeks of pregnancy. This ultrasound will be done during your regularly scheduled visit, so no extra appointments are needed. After delivery, your baby's health information will be reviewed from their medical chart.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants and their babies until June 2025 to measure transcutaneous bilirubin (TcB) levels in the newborns.

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NCT06407388

Ultrasound Findings in Diabetic Pregnancies

UNKNOWN
Not specifiedAges 18–45Observational
Eastern Virginia Medical School
~156 participants
Updated 2024-05-09 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Elevated TcB
Measured over June 2023 to June 2025
Diabetes
1 sites across 1 states
Virginia1

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Eligibility criteria

Inclusion

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

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)
  • Elevated TcBJune 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.