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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstitut d'Investigacions Biomèdiques August Pi i Sunyer

About this trial

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 criteria

Qualifiers

Age ≥ 18 years

Confirmed diagnosis of type 1 diabetes

At least one prior pregnancy with first-trimester preeclampsia screening (<14 weeks gestation)

≥3 years since last pregnancy

Disqualifiers

Previous multiple pregnancy

Cardiovascular disease before pregnancy (coronary heart disease, stroke/TIA, peripheral artery disease, heart failure)

Active pregnancy at time of evaluation

Alcohol or substance dependence (except nicotine/caffeine) in the last 3 years

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,300 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Lead sponsor

Hospital Mutua de Terrassa

Collaborator

Sociedad Española de Endocrinología y Nutrición

Collaborator