An observational study in Fetal Cardiac Anomaly and Gestational Diabetes, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Status unknown at 1 site in Mexico. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Observational
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Diagnostic Test: Fetal echocardiography
This group will be formed by women with normal 75 g OGTT findings.
Diagnostic Test: 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.
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.
Time frame: 45-60 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitario Dr. Jose E. Gonzalez