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

Gestational Diabetes Clinical Trial

Official title:

Fetal Cardiac Function Parameters and HbA1c as Screening for Gestational Diabetes Mellitus: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019508
• Other study ID #: 210175
• Status: Recruiting
• Start date: August 13, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2021
• Source: University of Virginia
• Contact: Frederick W Loehr, MD
• Phone: 8043804798
• Email: fwl4f[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Gestational diabetes mellitus (GDM) is the onset of carbohydrate intolerance that affects up to 6-9% of pregnancies. A diagnosis of GDM conveys numerous implications for the health of the mother and the fetus if not properly identified and/or treated. Maternal complications include increased risk of preeclampsia and development of Type 2 diabetes mellitus later in life. The risks to the fetus include increased risk of macrosomia, stillbirth, hypoglycemia, shoulder dystocia as well as increased risk of childhood obesity and diabetes.

Per ACOG guidelines, women who are at an increased risk for undiagnosed pre-gestational diabetes mellitus or developing GDM should receive early screening when they initially present for prenatal care, most commonly in the late first or early second trimester.5 The best test for this early assessment is not yet established. Practices patterns vary between use of the two-step oral glucose tolerance screening and glycated hemoglobin (HbA1c). Use of the oral glucose tolerance tests for screening of GDM is well-established and the cut-offs determined for 24-28 week routine screening are used when the oral tolerance tests are administered in early pregnancy. An HbA1c level ≥6.5% is used to diagnose diabetes, however there is evidence that there is a higher rate of GDM diagnosis and poor outcomes with a HbA1c level as low as 5.6%. Women who are not diagnosed with GDM before 20 weeks, go on to routine screening at 24-28 weeks.

With the current protocols for early GDM screening, treatment of early glucose intolerance has not shown to improve neonatal outcomes, however. The methods and timing of current early GDM screening may not be identifying a population that is truly at risk of poor outcomes from glucose intolerance in the way routine screening with the two-step process does. More research into screening paradigms other than oral tolerance tests in early pregnancy is needed. A HbA1c level assesses the amount glycation of hemoglobin molecules in red blood cells, indirectly estimating the average blood glucose level over the past 8-12 weeks. HbA1c independently has not been shown to be adequately predictive of a GDM diagnosis in pregnancy. Many studies assessing the screening value of HbA1c obtain the value in the first trimester when a large portion of the 12 weeks prior is before significant placentation. A change in HbA1c in the first half of pregnancy, when combined with other clinical variables may be more predictive. Novel clinical variables should also be considered. There is evidence that even well-control pre-gestational and gestational diabetics show significant variation in fetal cardiac functional parameters such as interventricular septum thickness (IVS), the E/A ratio, and myocardial performance index (MPI). The predictive value of these changes for glucose intolerance has not yet been investigated.

This is be 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, ?CFP, ?HbA1c (independently and in conjunction) which maximize sensitivity, specificity, and PPV for GDM.	one year
Secondary	Secondary outcomes	Secondary outcomes will be the change in fetal cardiac function parameters (?CFP) between 20 weeks and 24-28 weeks assessments, HbA1c results, ?HbA1c results, diagnosis of GDM.	one year
Secondary	Secondary neonatal outcomes	These include birth weight, hypoglycemia, NICU admission etc.	one year