Fetal Cardiac AnomalyNCT05260931
Fetal Cardiac Remodeling in Gestational Diabetic Pregnancies at the Moment of Diagnosis
An observational study of Fetal Cardiac Anomaly and Gestational Diabetes, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
The aim of the present study will be to evaluate whether fetal cardiac remodeling is already present at the moment of the diagnosis of gestational diabetes (GD) in comparison with fetuses of healthy pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Cardiac Anomaly, Gestational Diabetes
- What is being tested?
- Fetal echocardiography
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2021to 5 Mar 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of patients with singleton spontaneously conceived pregnancies who will undergo 75g OGTT at 24-28.6 weeks, with regular medical checkups throughout their entire pregnancy, delivered after 24-week gestation and fulfilled inclusion criteria. This study will be performed according to the standards of the Helsinki Declaration and approval will be obtained from the ethics and educational issues coordinating committee of our University Hospital.
Who may be able to join
- All pregnant women who will undergo 75g OGTT between 24 and 28.6 weeks of gestation will be invited to participate. Before being recruited, the objective of the research will be explained, the confidential nature of the information and informed consent will be requested. Inclusion criteria: singleton spontaneously conceived pregnancy, first trimester ultrasound screening to establish gestational age and first trimester serum glycemia < 92 mg/dL.
Who cannot join
- Those women with conditions or comorbidities that could induce cardiac remodeling and suboptimal function or could modify fetal growth will be excluded: fetus conceived by ssisted reproductive technology, pregestational diabetes, systemic lupus erythematosus, antiphospholipid antibody syndrome and other thrombophilias, heart disease, chronic pulmonary or renal disease, and thyroid disease. In addition, any hypertensive disease in pregnancy or derived complications (chronic arterial hypertension, gestational hypertension, pre-eclampsia, eclampsia). Patients with exposure to substances that could affect fetal weight will be excluded: teratogens (cyclophosphamide, valproic acid, antithrombotic drugs), tobacco, alcohol, cocaine or coffee consumption of more than 1 cup/day. Finally, women with a history of intrauterine growth restriction (IUGR) and/or preeclampsia in previous pregnancies, high risk of IUGR and/or preeclampsia in the current pregnancy estimated at first trimester screening, mean uterine artery greater than the 95th percentile for gestational age at 24-28.6 weeks, fetal structural defects or markers of aneuploidy on first or second trimester ultrasonography will be also excluded.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario "Dr. José E. González" UANL
Monterrey, Nuevo León
Flavio Hernández Castro, PhD, 8112776459, flaviohernandezc@yahoo.com
About this study
The aim of the present study will be to evaluate whether fetal cardiac remodeling is already present at the moment of the diagnosis of gestational diabetes (GD) in comparison with fetuses of healthy pregnant women.
Read the detailed description
We will recruited patients at the time of 75-g oral glucose tolerance test (OGTT); GDM will be diagnosed at 24-28.6 weeks when one or more of the venous plasma glucose measurements met or exceeded the following thresholds: fasting blood glucose ≥ 92 mg/dL; 1 h plasma glucose level ≥ 180 mg/dL; or 2 h plasma glucose level ≥ 153 mg/dL, as recommended by the International Association of the Diabetes and Pregnancy Study Groups. Consecutive women with singleton pregnancies with negative OGTT findings wil be also recruited during this period.
Maternal Characteristics The baseline variables, including maternal age, height, weight (1st ans 2nd trimester), parity will be collected at the time of the ultrasound examination. Additionally, fasting blood glucose, 1 h plasma glucose level and 2 h plasma glucose level in 75-g OGTT and glycated hemoglobin A1 (HbA1c) will be recorded. Body mass index of all mothers will be calculated.
Ultrasonographic examination using Voluson E6 (GE Medical Systems, Milwaukee, MI, USA) with 2-8 MHz linear curved-array probes, including estimated fetal weight, anomaly scan, and fetal echocardiography. The images will be recorded as clips and anonymized, and all the measurements will be performed offline.
Fetal biometric measurements will be obtained following ISUOG recommendations and fetal weight with Hadlock 4 formula.
Comprehensive two-dimensional, M-mode, and Doppler echocardiographic examination will be performed to rule out cardiac defects, and to evaluate cardiac morphometry and function following standard protocols. Cardiac, thoracic, and ventricular areas and diameters will be measured on 2-dimensional images from an apical or basal four-chamber (4 ChV) view at end diastole. Ventricular sphericity indices calculated by dividing the longitudinal by basal-transverse ventricular diameters. Atrial areas measured at maximum distension at end of systole. Atria and ventricle to-heart ratios will be calculated. Myocardial wall thicknesses measured on M-mode images from a transverse 4 ChV. Ventricular ejection fractions will be obtained from M-mode transverse 4 ChV using the Teichholz's formula. MAPSE/TAPSE will be assessed by M-mode from an apical or basal 4 ChV. Mitral and tricuspid early and late ventricular filling will be obtained by Doppler, and E/A ratios calculated. The left and right myocardial performance indices obtained from Doppler spectrum in a cross-sectional image of the thorax.
- Conditions
- Fetal Cardiac Anomaly, Gestational Diabetes
- Being tested
- Fetal echocardiography
- Keywords
- Fetal heart, Cardiac remodeling, Gestational diabetes, Pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal echocardiographyDiagnostic test
Two-dimensional, M mode, and Doppler echocardiographic examination performed to rule out cardiac defects and to evaluate cardiac morphometry and function. Cardiac, thoracic, and ventricular areas and diameters measured on 2-dimensional images from an apical or basal four-chamber (4 ChV) view at end diastole. Ventricular sphericity indices calculated by dividing the longitudinal by basal-transverse ventricular diameters. Atrial areas at maximum distension at end of systole. Atria and ventricle to-heart ratios calculated. Myocardial wall thicknesses and ventricular shortening/ejection fractions obtained from M-mode transverse 4 ChV. MAPSE/TAPSE assessed by M-mode from an apical or basal 4 ChV. Mitral and tricuspid early and late ventricular filling obtained by Doppler, and E/A ratios calculated. Left and right myocardial performance indices obtained from Doppler spectrum in a cross-sectional image of the thorax.
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes group | This group will be formed by women with gestational diabetes (GD). The diagnosis of GD was made when one or more of the venous plasma glucose measurements met or exceeded the following thresholds after a 75 g Oral Glucose Tolerance Test (75 g OGTT): fasting blood glucose ≥ 92 mg/dL, 1 h plasma glucose level ≥ 180 mg/dL or 2 h plasma glucose level ≥ 153 mg/dL, as recommended by the International Association of the Diabetes and Pregnancy Study Groups. Receives: Diagnostic Test: Fetal echocardiography | |
| Control group | This group will be formed by women with normal 75 g OGTT findings. Receives: Diagnostic Test: Fetal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular sphericity indices
Left and right Ventricular sphericity indices will be calculated by dividing the longitudinal by basal-transverse ventricular diameters on 2-dimensional images from an apical or basal four-chamber (4 ChV) view at end diastole.
Measured: 45-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 May 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion5 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Cardiac AnomalyStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Flavio Hernández Castro, MD PhD, Principal investigator, Hospital Universitario UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260931
- Sponsor's protocol ID
- GI18-0012
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Cardiac Remodeling in Gestational Diabetic Pregnancies at the Moment of Diagnosis
- ClinicalTrials.gov ID
- NCT05260931
- Acronym / sponsor ID
- GI18-0012
- Conditions
- Fetal Cardiac Anomaly, Gestational Diabetes
- Keywords
- Fetal heart, Cardiac remodeling, Gestational diabetes, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 5 Mar 2022 (estimated)
- First posted
- 2 Mar 2022 (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.
The aim of the present study will be to evaluate whether fetal cardiac remodeling is already present at the moment of the diagnosis of gestational diabetes (GD) in comparison with fetuses of healthy pregnant women.
Detailed description
We will recruited patients at the time of 75-g oral glucose tolerance test (OGTT); GDM will be diagnosed at 24-28.6 weeks when one or more of the venous plasma glucose measurements met or exceeded the following thresholds: fasting blood glucose ≥ 92 mg/dL; 1 h plasma glucose level ≥ 180 mg/dL; or 2 h plasma glucose level ≥ 153 mg/dL, as recommended by the International Association of the Diabetes and Pregnancy Study Groups. Consecutive women with singleton pregnancies with negative OGTT findings wil be also recruited during this period.
Maternal Characteristics The baseline variables, including maternal age, height, weight (1st ans 2nd trimester), parity will be collected at the time of the ultrasound examination. Additionally, fasting blood glucose, 1 h plasma glucose level and 2 h plasma glucose level in 75-g OGTT and glycated hemoglobin A1 (HbA1c) will be recorded. Body mass index of all mothers will be calculated.
Ultrasonographic examination using Voluson E6 (GE Medical Systems, Milwaukee, MI, USA) with 2-8 MHz linear curved-array probes, including estimated fetal weight, anomaly scan, and fetal echocardiography. The images will be recorded as clips and anonymized, and all the measurements will be performed offline.
Fetal biometric measurements will be obtained following ISUOG recommendations and fetal weight with Hadlock 4 formula.
Comprehensive two-dimensional, M-mode, and Doppler echocardiographic examination will be performed to rule out cardiac defects, and to evaluate cardiac morphometry and function following standard protocols. Cardiac, thoracic, and ventricular areas and diameters will be measured on 2-dimensional images from an apical or basal four-chamber (4 ChV) view at end diastole. Ventricular sphericity indices calculated by dividing the longitudinal by basal-transverse ventricular diameters. Atrial areas measured at maximum distension at end of systole. Atria and ventricle to-heart ratios will be calculated. Myocardial wall thicknesses measured on M-mode images from a transverse 4 ChV. Ventricular ejection fractions will be obtained from M-mode transverse 4 ChV using the Teichholz's formula. MAPSE/TAPSE will be assessed by M-mode from an apical or basal 4 ChV. Mitral and tricuspid early and late ventricular filling will be obtained by Doppler, and E/A ratios calculated. The left and right myocardial performance indices obtained from Doppler spectrum in a cross-sectional image of the thorax.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes group | – | Diagnostic Test: Fetal echocardiographyThis group will be formed by women with gestational diabetes (GD). The diagnosis of GD was made when one or more of the venous plasma glucose measurements met or exceeded the following thresholds after a 75 g Oral Glucose Tolerance Test (75 g OGTT): fasting blood glucose ≥ 92 mg/dL, 1 h plasma glucose level ≥ 180 mg/dL or 2 h plasma glucose level ≥ 153 mg/dL, as recommended by the International Association of the Diabetes and Pregnancy Study Groups. |
| Control group | – | Diagnostic Test: Fetal echocardiographyThis group will be formed by women with normal 75 g OGTT findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with singleton spontaneously conceived pregnancies who will undergo 75g OGTT at 24-28.6 weeks, with regular medical checkups throughout their entire pregnancy, delivered after 24-week gestation and fulfilled inclusion criteria. This study will be performed according to the standards of the Helsinki Declaration and approval will be obtained from the ethics and educational issues coordinating committee of our University Hospital.
Key inclusion criteria (1 listed)
- All pregnant women who will undergo 75g OGTT between 24 and 28.6 weeks of gestation will be invited to participate. Before being recruited, the objective of the research will be explained, the confidential nature of the information and informed consent will be requested. Inclusion criteria: singleton spontaneously conceived pregnancy, first trimester ultrasound screening to establish gestational age and first trimester serum glycemia < 92 mg/dL.
Key exclusion criteria (1 listed)
- Those women with conditions or comorbidities that could induce cardiac remodeling and suboptimal function or could modify fetal growth will be excluded: fetus conceived by ssisted reproductive technology, pregestational diabetes, systemic lupus erythematosus, antiphospholipid antibody syndrome and other thrombophilias, heart disease, chronic pulmonary or renal disease, and thyroid disease. In addition, any hypertensive disease in pregnancy or derived complications (chronic arterial hypertension, gestational hypertension, pre-eclampsia, eclampsia). Patients with exposure to substances that could affect fetal weight will be excluded: teratogens (cyclophosphamide, valproic acid, antithrombotic drugs), tobacco, alcohol, cocaine or coffee consumption of more than 1 cup/day. Finally, women with a history of intrauterine growth restriction (IUGR) and/or preeclampsia in previous pregnancies, high risk of IUGR and/or preeclampsia in the current pregnancy estimated at first trimester screening, mean uterine artery greater than the 95th percentile for gestational age at 24-28.6 weeks, fetal structural defects or markers of aneuploidy on first or second trimester ultrasonography will be also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal echocardiographyTwo-dimensional, M mode, and Doppler echocardiographic examination performed to rule out cardiac defects and to evaluate cardiac morphometry and function. Cardiac, thoracic, and ventricular areas and diameters measured on 2-dimensional images from an apical or basal four-chamber (4 ChV) view at end diastole. Ventricular sphericity indices calculated by dividing the longitudinal by basal-transverse ventricular diameters. Atrial areas at maximum distension at end of systole. Atria and ventricle to-heart ratios calculated. Myocardial wall thicknesses and ventricular shortening/ejection fractions obtained from M-mode transverse 4 ChV. MAPSE/TAPSE assessed by M-mode from an apical or basal 4 ChV. Mitral and tricuspid early and late ventricular filling obtained by Doppler, and E/A ratios calculated. Left and right myocardial performance indices obtained from Doppler spectrum in a cross-sectional image of the thorax. | Diagnostic test | Control group, Gestational diabetes group |
Primary outcome
Ventricular sphericity indices
Time frame: 45-60 minutes
Left and right Ventricular sphericity indices will be calculated by dividing the longitudinal by basal-transverse ventricular diameters on 2-dimensional images from an apical or basal four-chamber (4 ChV) view at end diastole.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Fetal Cardiac Anomaly
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
Pregnant Individuals, Aneuploidy
Not yet recruitingObservational study
Fetal Cardiac Anomalies at Anomaly Scan: Detection and Pregnancy Outcomes - Assiut 2026
Congenital Heart Defect, Heart Defects, Congenital
RecruitingObservational study
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
Fetal Growth Restriction, Cardiac Remodeling, Ventricular
Not yet recruitingObservational study
Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD
Congenital Heart Disease, Fetal Heart Disorder
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.
Flavio Hernández Castro, MD PhD principal investigator
Hospital Universitario UANL
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 Fetal Cardiac Anomaly and Gestational Diabetes, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavio Hernández Castro, MD PhD (8112776459, flaviohernandezc@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular sphericity indices (time frame: 45-60 minutes). 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 2 Mar 2022.