Ultrasound Findings in Diabetic Pregnancies

NCT ID: NCT06407388

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-06-01

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.

Conditions

Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: lead

Responsible Party

Alyssa Savelli-Binsted

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristin Ayers, MPH

Role: CONTACT

ayerskl@evms.edu

7574460579

Facility Contacts

Alyssa Savelli, MD

Role: primary

kawakit@evms.edu

757-446-7900

Kristin Ayers, MPH

Role: backup

ayerskl@evms.edu

7574460579

Other Identifiers

23-03-FB-0061

Identifier Type: -

Identifier Source: org_study_id