Ultrasound Findings in Diabetic Pregnancies

Recruiting

• Conditions: Diabetes

• Registration Number: NCT06407388
• Lead Sponsor: Eastern Virginia Medical School

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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 156

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Jaundice	June 2023 to June 2025	Jaundice requiring phototherapy

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States