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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ålesund Hospital Coordinator of this site? Confirm its status | Ålesund | Norway | Unknown status |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.