Ultrasound Findings in Diabetic Pregnancies

Diabetes Clinical Trial

Official title:

Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407388
• Other study ID #: 23-03-FB-0061
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Eastern Virginia Medical School
• Contact: Kristin Ayers, MPH
• Phone: 7574460579
• Email: ayerskl[@]evms.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Pregnancy in Diabetics

Locations

Country	Name	City	State
United States	Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elevated TcB	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.	June 2023 to June 2025
Secondary	Respiratory Distress	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	June 2023 to June 2025
Secondary	Jaundice	Jaundice requiring phototherapy	June 2023 to June 2025
Secondary	Hypoglycemia	<40 mg/dl in the first 24 hours of life	June 2023 to June 2025
Secondary	Polycythemia	Hematocrit >65% or hemoglobin >22 mg/dl	June 2023 to June 2025