Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes

Condition(s) studied

Study summary

This multicenter observational cohort study aims to evaluate whether estimated first-trimester risk of preeclampsia (PE) is associated with subclinical atherosclerosis, cardiovascular risk profile, and cardiovascular events in women with type 1 diabetes (T1D) at least 3 years after pregnancy.

Women with T1D and at least one prior pregnancy with documented first-trimester PE screening will be classified as high or low PE risk according to validated multivariable algorithms. The presence of carotid plaques, cardiometabolic risk factors, and incident cardiovascular events will be assessed during a study visit.

Eligibility

Primary outcome measure(s)

• Number of carotid plaques — At study visit (≥3 years postpartum)
  Presence of focal carotid plaque defined as focal wall thickening ≥1.5 mm detected by standardized 2D carotid ultrasound.
• Hemoglobin A1c (HbA1c) — At study visit (≥3 years postpartum)
  HbA1c measured at study visit
• Lipid profile — At study visit (≥3 years postpartum)
  Total cholesterol, triglycerides, HDL-cholesterol and Lipoprotein(a) measured directly. LDL-cholesterol estimated using the Friedewald formula.
• Blood pressure — At study visit (≥3 years postpartum)
  Systolic blood pressure and diastolic blood pressure.
• Body mass index — At study visit (≥3 years postpartum)
  Calculated as weight (in kg) / height (in meters) \^2
• Diabetic-related chronic microvascular complications — From the last pregnancy to the study visit (≥3 years postpartum)
  Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy
• Incident cardiovascular events — From last pregnancy to study visit (minimum 3 years)
  Composite of coronary artery disease, cerebrovascular disease, peripheral artery disease, or heart failure occurring between last pregnancy and study evaluation.

Trial sites (2)

More Institut d'Investigacions Biomèdiques August Pi i Sunyer trials in Spain

Other trials for the same condition