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

Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Study ID
NCT07479329
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Mar 18, 2026
Start date
Apr 10, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
1,300 participants (estimated)

Arms

  • Arm: High Estimated First-Trimester Preeclampsia Risk
    Women with type 1 diabetes classified as high risk for preeclampsia during first-trimester screening in at least one prior pregnancy.
  • Arm: Low Estimated First-Trimester Preeclampsia Risk
    Women with type 1 diabetes classified as low risk for preeclampsia during first-trimester screening in at least one prior pregnancy.

Primary Outcome Measure

Number of carotid plaques [ Time Frame: At study visit (≥3 years postpartum) ]

Central Contacts

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