NCT05260931|UnknownDMC
Loading search results
Sponsor study identifier
observational
150
1 country
1
Study Start
May 1, 2021
Actual (reported)Primary Completion
February 28, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 5, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 5, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2021
Actual (reported)February 20, 2022
Actual (reported)February 28, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2, 2022
Actual (reported)March 5, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
45-60 minutes
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.
This group will be formed by women with normal 75 g OGTT findings.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Hospital Universitario "Dr. José E. González" UANL
Monterrey, Nuevo León, Mexico
Flavio Hernández Castro, MD PhD
Hospital Universitario UANL
First Submitted
February 20, 2022
First Posted
March 2, 2022
Study Start
May 1, 2021
Actual (reported)Primary Completion
February 28, 2022
Estimated (date passed)SMS Counseling on Gestational Diabetes
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 5, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 2, 2022
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: