Actively Recruiting
Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks
Led by St. Olavs Hospital · Updated on 2025-06-05
300
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 include around 300 women 18 years or older with a singleton live fetus, gestational age between 24 and 28 weeks, 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 a adherence of at least 50% and low SFlt-1/PlGF ratio (Kryptor technology with cut-off 66). Randomization and masking Between 24 and 28 weeks of gestation, participants will be randomly designed, with a computer-based system in a 1:1 ratio, to continue aspirin (control group) or discontinue aspirin (intervention group). This is an open-label study without masking of patients or providers. Follow-up Both groups will have visits every 4 weeks between randomization and 36 weeks, and standard antenatal care after 37 weeks until delivery. Treatment adherence will be assessed by patient self-report and tablet count, and fetal growth and Doppler will be assessed at the scheduled visits between randomization and 36 weeks (at 24, 28, 32 and 36 weeks), and according to clinical judgement by obstetricians at the outpatient clinic of the hospital. Women will have a telephone/video link follow-up 1-2 months after birth
CONDITIONS
Official Title
Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Singleton live fetus with gestational age between 24 and 28 weeks
- High risk of preterm preeclampsia (>1/100) in the first trimester screening
- Aspirin treatment with 150 mg per day started at 16+6 weeks of gestation or earlier until randomization with at least 50% adherence
- Low SFlt-1/PlGF ratio measured at 24-28 weeks with Kryptor technology (cut-off 66)
You will not qualify if you...
- Not speaking Norwegian or English
- Fetal anomalies diagnosed by ultrasound
- Informed consent not given for participation in the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Olavs hospital
Trondheim, Norway
Actively Recruiting
Research Team
K
Kjell Å Salvesen, Professor
CONTACT
H
Hanne Mørch, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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