Fetal Cardiac Remodeling in Gestational Diabetic Pregnancies at the Moment of Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gestational Diabetes: a Cohort Study

NCT03307486

Gestational Diabetes Diabetes, Gestational Diabetes Mellitus in Pregnancy +1 more

ENROLLING_BY_INVITATION

Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy

NCT04417452

Diabetes, Gestational Pregnancy Diabetic

UNKNOWN

First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.

NCT06874907

Gestational Diabetes Mellitus in Pregnancy

RECRUITING

Gestational Diabetes Mellitus (GDM) in Pregnant Women

NCT05265741

Gestational Diabetes Mellitus Pregnancy Complications

UNKNOWN

Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women

NCT01756105

Gestational Diabetes Metformin Treatment +1 more

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Fetal Cardiac Anomaly Gestational Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Fetal echocardiography

Intervention Type DIAGNOSTIC_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.

Control group

This group will be formed by women with normal 75 g OGTT findings.

Fetal echocardiography

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fetal echocardiography

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes