Identifying ultrasound markers in pregnancies affected by diabetes
Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies
This study is trying to see if certain ultrasound signs in pregnant women with diabetes can help predict if their newborns will have jaundice that needs treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Eastern Virginia Medical School Academic / other |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT06407388 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify ultrasound findings that can predict adverse outcomes in newborns of diabetic pregnancies. Specifically, it hypothesizes that increased fetal liver volumes may correlate with higher transcutaneous bilirubin levels, leading to jaundice requiring treatment. The study will involve a single center where ultrasound data will be collected from pregnant women with type I or II diabetes during their routine 30-34 week ultrasound. Participants will be followed until delivery, and their newborns will be monitored for outcomes through chart reviews.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-45 with a diagnosis of type I or II diabetes and a singleton gestation.
Not a fit: Patients with multifetal gestation, chromosomal abnormalities, or major congenital malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance prenatal care by improving screening protocols for jaundice in newborns of diabetic mothers.
How similar studies have performed: While this approach is based on existing knowledge of ultrasound in diabetic pregnancies, the specific hypothesis regarding fetal liver volumes and bilirubin levels is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Norfolk, Virginia
- Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kristin Ayers, MPH
- Email: ayerskl@evms.edu
- Phone: 7574460579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.