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NCT06200571Enrolling by invitation

Biological Changes Associated With High Risk of Preeclampsia in Nulliparous Women

Characterization of the Immunological and Vascular Effects of Aspirin in Prevention of Preeclampsia in High-risk Nulliparous Women

Source: ClinicalTrials.gov · Last updated 12 Dec 2025

Brief summary (registry, in English)

Primary outcome 1. to identify biological changes in nulliparous women at high risk for preeclampsia defined by combined screening by Fetal Medicine Foundation (FMF) 2. to identify biological effects of aspirin in nulliparous women with high risk for preeclampsia Secondary outcomes include findings of longitudinal development and predictive potential of biological markers associated with high-risk for preeclampsia and aspirin treatment. The main questions it aims to answer are: * Is high risk for preeclampsia associated with biological changes during pregnancy? * How does aspirin modulate the biological changes associated with high risk for preeclampsia? Nulliparous women will undergo routine clinical care at two regional hospitals with different treatment strategies, and selected to the study in three groups: low risk of preeclampsia, high risk of preeclampsia without aspirin, and high-risk of preeclampsia with aspirin treatment.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
200 (estimated)
First submitted
8 Dec 2023
Start date
22 May 2024
Primary completion date
31 Dec 2026
Lead sponsor
Norwegian University of Science and Technology
NCT number
NCT06200571

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 22 May 2024 to the primary completion date, 31 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • not speaking Norwegian or English language
  • fetal anomalies diagnosed with ultrasound

Who the study is looking for

  • 18 years or older
  • nulliparous women
  • singleton live fetus
  • FMF risk \> 1/100 (high risk), or \< 1/150 (low risk)

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ålesund Hospital
Coordinator of this site? Confirm its status
ÅlesundNorwayUnknown status
St Olavs Hospital
Coordinator of this site? Confirm its status
TrondheimNorwayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.