Recruiting

Observational Study

Sponsor:

Eastern Virginia Medical School

Code:

NCT06407388

Conditions

Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Diabetes

Study ID

NCT06407388

Start date

Jun 1, 2023

Status verified date

May, 2024

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Enrollment

156 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • Elevated TcB [ Time Frame: June 2023 to June 2025 ]

Central Contacts and Locations

Central contacts

Kristin Ayers, MPH

7574460579ayerskl@evms.edu

Locations

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

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Alyssa Savelli, MD

757-446-7900kawakit@evms.edu

Kristin Ayers, MPH

7574460579ayerskl@evms.edu

Principal Investigator:

Alyssa Savelli, MD

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

May 9, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2024-05-09.