Status:
RECRUITING
Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks
Lead Sponsor:
St. Olavs Hospital
Conditions:
Pre-Eclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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, b...
Detailed Description
The implementation study is divided into four parts/study questions 1. Is screening for preeclampsia cost-effective in a Norwegian setting? Folkehelseinstituttet (FHI) in Norway has done a health...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 18 years or older
- singleton live fetus with gestational age between 24 and 28 weeks
- woman with high risk of preterm preeclampsia (\>1/100) in the first trimester screening
- aspirin treatment with a dose 150 mg per day initiated at 16+6 weeks of gestation or less until randomization with adherence of at least 50%
- low SFlt-1/PlGF ratio (Kryptor technology with cut-off 66) measured at 24-28 weeks
- Exclusion Criteria
- not speaking Norwegian or English language
- fetal anomalies diagnosed with ultrasound
- informed consent for participation in the trial
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06108947
Start Date
January 1 2024
End Date
June 1 2027
Last Update
June 5 2025
Active Locations (1)
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1
St. Olavs hospital
Trondheim, Norway