Fetal Cardiac Function Parameters and HbA1c As Screening for Gestational Diabetes Mellitus

NCT05019508 | Completed

• 1 other identifier: 210175
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study to assess the predictive value of fetal cardiac parameters, the change in fetal cardiac parameters (CFP), HbA1c, and/or the change in HbA1c (ΔHbA1c) for gestational diabetes.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• We will assess the predictive ability of fetal Cardiac Function Parameter for diagnosis of Gestational Diabetes Mellitus by oral glucose tolerance tests

  Area under the curve statistics will be used to assess values of CFP, ΔCFP, ΔHbA1c (independently and in conjunction) which maximize sensitivity, specificity, and PPV for GDM.

  one year

Secondary Outcomes (2)

• Secondary outcomes

  one year

• Secondary neonatal outcomes

  one year

Study Arms (1)

High Risk for Gestational Diabetes Mellitus (GDM)

High risk women screened with HbA1c at initiation of prenatal care who were not diagnosed with Type 2 Diabetes Mellitus or Early GDM. These women will have Fetal Cardiac Function Parameters at their 20 week anatomy scan (E/A ratio, IVS, MPI). At their 24-28 week routine GDM screening, we will repeat the HbA1c and will repeat the E/A ratio, IVS, MPI. If women have a growth scan for any reason between 32 and 36 weeks, E/A ratio, IVS, and MPI will be repeated at those times.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women being see in the Maternal Fetal Medicine clinic at the Battle Building at the University of Virginia.

You may qualify if:

• Pregnant women who have completed a HbA1c test during the first 20 weeks of pregnancy.
• Risk for GDM including any of the following:
• Obese
• History of GDM
• History of macrosomia
• Twin gestation
• PCOS
• Family history of diabetes

You may not qualify if:

• Pregnant women who have not completed a HbA1c test during the first 20 weeks of pregnancy.
• women with pre-gestational diabetes
• nonviable pregnancy
• fetal anomalies

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christoher Ennen, MD

  UVA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 25, 2021
• Study Start: August 13, 2021
• Primary Completion: August 18, 2022
• Study Completion: April 10, 2023
• Last Updated: January 16, 2025

Record last verified: 2023-08

Locations

US (1)