No phaseActive, not recruiting
Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks (PEScreenNor)
Implementing Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks - a Randomized Controlled Trial
- Sponsor
- St. Olavs Hospital (Academic or other)
- Enrolment
- 300 planned
- Conditions
- Pre-Eclampsia
- Interventions
- Aspirin
- Ages
- adults, older adults
- Registry
- NCT06108947
Full record on ClinicalTrials.gov
From the registry
Study population Around 3500 pregnant women attending a routine ultrasound scan at 11-14 weeks at St. Olavs hospital, Trondheim, Norway. Study period Dec 2023 - Jul 2025 Screening Patient history, blood pressure, uterine artery mean PI and PlGF will be plotted in the FMF algorithm for screening for preeclampsia in the first trimester. Standardized blood pressure will be measured by trained personnel. Ultrasound scans will be performed by FMF certified doctors and midwives working at the Center for Fetal Medicine in Trondheim. Placenta growth factor (PLGF) will be analyzed with Kryptor technology at Center for Laboratory Medicine, St. Olavs hospital. Prophylaxis Women with high risk for preterm preeclampsia (risk \> 1:100) will be offered aspirin prophylaxis 150 mg x 1 from 11-14 weeks to 36 weeks. Women will be offered to participate in a randomized controlled trial (RCT). Study design and participants in the RCT A single center, open label, randomized, noninferiority trial conducted at St. Olavs hospital, Trondheim Norway from Dec 2023 to Jul 2025. The investigators will…
Primary outcomes
- Number of patients with preterm preeclampsia
History
Study completion expected
Last registry update
Primary completion
Started
Registered