Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations.
N O'Gorman, D Wright, L C Poon...
https://pubmed.ncbi.nlm.nih.gov/28295782Actively Recruiting
FEMALE
Healthy Volunteers
ID07485140
Prevention of Preeclampsia in Denmark (PREPRED): A National Implementation Study
Led by Copenhagen University Hospital at Herlev · Updated on 2026-03-20
80000
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Copenhagen University Hospital at Herlev
Lead Sponsor
A
Aarhus University Hospital Skejby
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new first-trimester screening program in Denmark to better identify pregnant women at high risk of developing preeclampsia, a condition causing high blood pressure and affecting both mother and baby's health. The study aims to see if early detection and preventive treatment with low-dose aspirin can lower the number of women who develop preterm preeclampsia. This observational study is conducted in routine maternity care settings and includes pregnant women with single pregnancies attending first-trimester scans. The screening combines maternal history, blood pressure, ultrasound blood flow measurements, and blood tests to estimate individual risk. Women identified as high risk are offered daily low-dose aspirin until late pregnancy. The program is gradually introduced across hospitals, allowing researchers to compare outcomes before and after implementation while integrating the screening into existing prenatal care workflows without disrupting services. Participants receive information and routine assessments during their first-trimester visit, including blood pressure checks, ultrasound, and blood sampling. Researchers will monitor pregnancy outcomes, aspirin use, and safety through national health records and registries. The study also assesses the screening program's feasibility, acceptability, and safety, with ongoing training and quality checks. The total follow-up extends from the first-trimester assessment through delivery.
CONDITIONS
Brief Title
Prevention of Preeclampsia in Denmark: A National Implementation Study
Who Can Participate
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pregnant women with a viable singleton pregnancy
- Attendance at a routine first-trimester ultrasound scan between 11+0 and 13+6 weeks of gestation at a Danish maternity hospital during the study period
- Valid Danish personal identification number enabling linkage with national health registries
You will not qualify if you...
- Multiple pregnancy (twins or more)
- Major fetal anomaly diagnosed before completion of first-trimester screening
- Miscarriage or pregnancy loss diagnosed before completion of first-trimester screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine first-trimester ultrasound scan between 11+0 and 13+6 weeks of gestation
Surveillance
Duration - From first-trimester screening until delivery
Participants who undergo routine antenatal care are observed through linkage of screening measurements, biochemical markers, and national health registries to monitor pregnancy outcomes and prophylactic treatment uptake.
Routine antenatal visits as per standard care; no additional study visits required
Trial Site Locations
Total: 3 locations
1
Aarhus University
Aarhus, Denmark, 8200
Actively Recruiting
2
University of Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
3
University of Copenhagen
Hillerød, Denmark, 3400
Actively Recruiting
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Research Team
C
Charlotte Kvist Ekelund, Consultant, ass. prof. PhD
I
Iben Riishede, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Aspirin for Evidence-Based Preeclampsia Prevention trial: effect of aspirin on length of stay in the neonatal intensive care unit.
David Wright, Daniel L Rolnik, Argyro Syngelaki...
https://pubmed.ncbi.nlm.nih.gov/29505771Pre-eclampsia screening in Denmark (PRESIDE): national validation study.
I Riishede, L Rode, L Sperling...
https://pubmed.ncbi.nlm.nih.gov/36840981Accuracy of competing-risks model in screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation.
N O'Gorman, D Wright, L C Poon...
https://pubmed.ncbi.nlm.nih.gov/28067011Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia.
Daniel L Rolnik, David Wright, Liona C Poon...
https://pubmed.ncbi.nlm.nih.gov/28657417