NCT07479329

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (estimated)
• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Preeclampsia (PE) is associated with increased long-term cardiovascular disease (CVD) risk. Women with type 1 diabetes (T1D) are at particularly high risk of both obstetric and cardiovascular complications. Although clinical PE has been associated with subclinical carotid atherosclerosis and future cardiovascular events in women with T1D, it is unknown whether estimated first-trimester PE risk identifies a subgroup at increased long-term cardiovascular risk, regardless of the development of clinical PE. Participants will be women with T1D followed in endocrinology clinics across Spain. Eligible participants must have undergone first-trimester PE screening (\<14 weeks gestation) in at least one pregnancy and be at least 3 years from their last delivery. The primary exposure variable is first-trimester estimated PE risk (high vs low). Outcomes include subclinical carotid atherosclerosis, cardiometabolic risk profile, and incident cardiovascular events. Secondary outcomes include glycemic metrics from continuous glucose monitoring, cardiovascular health score (Life's Essential 8), patient-reported outcomes, and the effectiveness of aspirin in preventing clinical PE. Data will be collected in a single study visit using medical records, physical examination, validated questionnaires, and carotid ultrasound (in centers with availability).

Conditions

• Type 1 Diabetes
• Preeclampsia
• Preeclampsia (PE) Risk

Timeline

• Start date: 2026-04-10
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

2 sites across 1 country: Spain