Clinical trial NCT06407388: Ultrasound Findings in Diabetic Pregnancies
Official title: Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility 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)

Primary outcomes:
measure: Elevated TcB
timeFrame: June 2023 to June 2025
Secondary outcomes:
measure: Respiratory Distress
timeFrame: June 2023 to June 2025
measure: Jaundice
timeFrame: June 2023 to June 2025
measure: Hypoglycemia
timeFrame: June 2023 to June 2025
measure: Polycythemia
timeFrame: June 2023 to June 2025
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School
state: Virginia
Study officials:
References: