Gestational DiabetesNCT05019508
Fetal Cardiac Function Parameters and HbA1c As Screening for Gestational Diabetes Mellitus
An observational study of Gestational Diabetes, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 10 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All pregnant women being see in the Maternal Fetal Medicine clinic at the Battle Building at the University of Virginia.
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Fetal Cardiac Function Parameters and HbA1c As Screening for Gestational Diabetes Mellitus: a Pilot Study
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.
Read the detailed 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.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
Secondary outcomes
Secondary outcomes will be the change in fetal cardiac function parameters (ΔCFP) between 20 weeks and 24-28 weeks assessments, HbA1c results, ΔHbA1c results, diagnosis of GDM.
Measured: one year
Secondary neonatal outcomes
These include birth weight, hypoglycemia, NICU admission etc.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start13 Aug 2021
- Primary completion18 Aug 2022
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher S. Ennen, University of Virginia
- Investigators
- Christoher Ennen, MD, Study director, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019508
- Sponsor's protocol ID
- 210175
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Cardiac Function Parameters and HbA1c As Screening for Gestational Diabetes Mellitus: a Pilot Study
- ClinicalTrials.gov ID
- NCT05019508
- Acronym / sponsor ID
- 210175
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant women being see in the Maternal Fetal Medicine clinic at the Battle Building at the University of Virginia.
Key inclusion criteria (8 listed)
- Pregnant women who have completed a HbA1c test during the first 20 weeks of pregnancy.
- Risk for GDM including any of the following:
Key exclusion criteria (4 listed)
- • Pregnant women who have not completed a HbA1c test during the first 20 weeks of pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We will assess the predictive ability of fetal Cardiac Function Parameter for diagnosis of Gestational Diabetes Mellitus by oral glucose tolerance tests
Time frame: one year
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.
2 secondary outcomes
Secondary outcomes
Time frame: one year
Secondary neonatal outcomes
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoher Ennen, MD study director
UVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will assess the predictive ability of fetal Cardiac Function Parameter for diagnosis of Gestational Diabetes Mellitus by oral glucose tolerance tests (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.