Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School
RECRUITING
Norfolk
Contact Information
Primary
Kristin Ayers, MPH
ayerskl@evms.edu
7574460579
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 156
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Eastern Virginia Medical School

This content was sourced from clinicaltrials.gov