Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06108947

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

St. Olavs hospital

Trondheim, Norway

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks | DecenTrialz