Ultrasound Findings in Diabetic Pregnancies

Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 156

Contacts and Locations

• Study Contact: Name: Kristin Ayers, MPH; Phone Number: 7574460579; Email: ayerskl@evms.edu

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School
      • Contact: Kristin Ayers, MPH; Phone Number: 7574460579; Email: ayerskl@evms.edu
      • Contact: Alyssa Savelli, MD; Phone Number: 757-446-7900; Email: kawakit@evms.edu
      • Principal Investigator: Alyssa Savelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases; Criteria for inclusion of subjects; 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 Criteria for exclusion of subjects; 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)
Controls; The control group will be a referent population of the Human Placenta Project. This reference population consists of patients who meet the following criteria: Maternal: Pregnancy Conceived Without Assisted Reproduction; Singleton gestation; Delivery: >37 0/7 weeks gestation; No gestational diabetes; No fetal growth restriction; No Smoking/ Alcohol/Drugs History;; Placenta Implantation: Normal; Fetal Umbilical Cord abnormalities: None; Fetal- Newborn Outcomes: Gestational Age at Delivery: >37 0/7; No Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19; No Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc); Fetal -Newborn Weight >10 percentile ( no Hx of FGR or SGA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Jaundice	Jaundice requiring phototherapy	June 2023 to June 2025
Hypoglycemia	<40 mg/dl in the first 24 hours of life	June 2023 to June 2025
Polycythemia	Hematocrit >65% or hemoglobin >22 mg/dl	June 2023 to June 2025

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy in Diabetics
• Other Study ID Numbers: 23-03-FB-0061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No