National first-trimester screening program to prevent preeclampsia in Denmark
Official title: Prevention of Preeclampsia in Denmark (PREPRED): A National Implementation Study
Run by Copenhagen University Hospital at Herlev · NCT07485140 · Data updated 2026-11-12
This program will try a new first-trimester screening for pregnant women with a single pregnancy in Denmark to find those at high risk of preeclampsia and offer early prevention such as low-dose aspirin.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 80000 (estimated) |
| Sponsor | Copenhagen University Hospital at Herlev Academic / other |
| Locations | 3 sites (Aarhus and 2 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT07485140 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women with a viable singleton pregnancy attending a routine first‑trimester ultrasound at 11+0 to 13+6 weeks at a participating Danish maternity hospital who have a valid Danish personal identification number.
✕Probably not a fit
Women with multiple pregnancies, a major fetal anomaly or pregnancy loss diagnosed before completion of first‑trimester screening, or those who do not attend participating Danish hospitals or are beyond the first‑trimester window are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This implementation project will introduce a structured first-trimester risk assessment across Danish maternity hospitals using a multivariable model that combines maternal history with measurements such as mean arterial pressure, uterine artery Doppler, placental growth factor, and PAPP‑A. Pregnant women with viable singleton pregnancies attending routine 11+0 to 13+6‑week scans will undergo the screening and, if identified as high risk, be offered preventive measures such as low‑dose aspirin. Sites will be gradually rolled out nationally and linked to comprehensive Danish health registries to monitor outcomes, safety, and acceptability among women and healthcare professionals. The primary aim is to see if this program lowers rates of preterm preeclampsia and is feasible in routine prenatal care.
Why it matters
Potential benefit: If successful, the program could reduce cases of preterm preeclampsia and related maternal and neonatal complications by enabling earlier preventive treatment.
How similar studies have gone: Previous randomized trials and implementation studies using first‑trimester risk models combined with prophylactic low‑dose aspirin have reduced preterm preeclampsia, and Danish validation studies support the model being implemented here.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with a viable singleton pregnancy * Attendance at a routine first-trimester ultrasound scan at 11+0 to 13+6 weeks of gestation at a Danish maternity hospital during the study period * Valid Danish personal identification number (CPR number) enabling linkage with national health registries Exclusion Criteria: * Multiple pregnancy (e.g., twins or higher-order gestations) * Major fetal anomaly diagnosed before completion of first-trimester screening * Miscarriage or pregnancy loss diagnosed before completion of first-trimester screening
Where it's running
-
Aarhus University
Aarhus, Denmark Recruiting -
University of Copenhagen
Copenhagen, Denmark Recruiting -
University of Copenhagen
Hillerød, Denmark Recruiting
Study contacts
- Principal investigator: Charlotte Kvist Ekelund, Consultant, ass. prof., MD — Copenhagen University Hospital, Rigshospitalet
- Study coordinator: Charlotte Kvist Ekelund, Consultant, ass. prof. PhD
- Email: charlotte.kvist.ekelund@regionh.dk
- Phone: +45 28265042
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This study tests whether blood proteins can reveal early heart changes in pregnant women with preeclampsia and uses heart ultrasound to see how the heart changes during pregnancy.
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This project will test an app-based algorithm to see if it can identify cardiovascular risk in women 3–6 years after giving birth, including those who had preeclampsia or low-birth-weight infants.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.