NCT06407388

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

May 6, 2024

Last Update Submit

May 6, 2024

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Respiratory Distress

    June 2023 to June 2025

  • Jaundice

    June 2023 to June 2025

  • Hypoglycemia

    June 2023 to June 2025

  • Polycythemia

    June 2023 to June 2025

Study Arms (2)

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)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Kristin Ayers, MPH

CONTACT

7574460579ayerskl@evms.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

June 1, 2023

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

US(1)