Status:
UNKNOWN
Fetal Cardiac Remodeling in Gestational Diabetic Pregnancies at the Moment of Diagnosis
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Fetal Cardiac Anomaly
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Brief 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 p...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 5 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05260931
Start Date
May 1 2021
End Date
March 5 2022
Last Update
March 2 2022
Active Locations (1)
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1
Hospital Universitario "Dr. José E. González" UANL
Monterrey, Nuevo León, Mexico