Trials Sponsors Conditions Drugs Pricing

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

Age18 Years - 50 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-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.

Sponsors & Collaborators

University of Virginia
Otherlead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Christoher Ennen, MD
UVA
STUDY DIRECTOR

Enrollment

114 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

High Risk for Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

High Risk for Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations