Screening for preeclampsia in pregnant women with aspirin discontinuation
Implementing Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks - a Randomized Controlled Trial
This study is testing a new way to screen for preeclampsia in pregnant women by checking their health history and blood pressure during early pregnancy to see if it helps identify those who might need aspirin to prevent complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT06108947 on ClinicalTrials.gov |
What this trial studies
This study involves around 3500 pregnant women attending routine ultrasound scans at St. Olavs Hospital in Trondheim, Norway. It aims to screen for preeclampsia by measuring patient history, blood pressure, and uterine artery parameters using the FMF algorithm during the first trimester. Women identified as high risk for preterm preeclampsia will receive aspirin prophylaxis and may participate in a randomized controlled trial to assess the cost-effectiveness of this screening approach. The study will also compare blood pressure measurements taken at general practitioners' offices with standardized measurements at the hospital.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older with a singleton live fetus between 24 and 28 weeks and a high risk of preterm preeclampsia.
Not a fit: Patients who do not speak Norwegian or English, have fetal anomalies, or cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and prevention of preeclampsia, potentially reducing associated complications for mothers and infants.
How similar studies have performed: Other studies have shown success with similar screening approaches for preeclampsia, indicating potential for this method to be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trondheim
- St. Olavs hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Kjell Å Salvesen, Professor — St. Olavs Hospital
- Study coordinator: Kjell Å Salvesen, Professor
- Email: pepes@ntnu.no
- Phone: +47 41240404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.