Prevention of Preeclampsia in Denmark: A National Implementation Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorCopenhagen University Hospital at Herlev

About this trial

The goal of this clinical study is to learn if a new first-trimester screening program can better find pregnant women who are at high risk of developing preeclampsia and help prevent the condition with early treatment.

Preeclampsia is a pregnancy condition that causes high blood pressure and can affect the mother's organs and the baby's growth. Early detection allows doctors to offer preventive treatment, such as low-dose aspirin, which may lower the risk of serious illness.

The study includes pregnant women with a single pregnancy who attend their routine first-trimester scan at maternity hospitals in Denmark.

The main questions it aims to answer are:

Does the new screening program lower the number of women who develop preterm preeclampsia (preeclampsia before thirty-seven weeks of pregnancy)?

Can the screening program be carried out safely and be acceptable for pregnant women and healthcare professionals?

Researchers will gradually introduce the new screening program across hospitals and compare outcomes before and after the program starts. Women who are found to have a high risk of preeclampsia will be offered preventive treatment with low-dose aspirin.

Participants will:

Receive information about preeclampsia and the screening during their first-trimester visit

Have their blood pressure measured and an ultrasound assessment of blood flow to the uterus during the routine scan

Have routine blood samples analysed to estimate their personal risk of preeclampsia

Be offered daily low-dose aspirin until late pregnancy if they are identified as high risk

Continue standard pregnancy care while researchers follow pregnancy outcomes using national health records

The study will help researchers understand whether this screening approach works in everyday care and whether it should become part of routine pregnancy care in Denmark.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • First trimester screening for preeclampsia

Treatment groups

80,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Copenhagen University Hospital at Herlev

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Aarhus University Hospital Skejby

Collaborator

Odense University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Copenhagen University Hospital, Hvidovre

Collaborator

Nordsjaellands Hospital

Collaborator

Slagelse Hospital

Collaborator

Holbaek Sygehus

Collaborator

Nykøbing Falster County Hospital

Collaborator

Bornholm Hospital, Denmark

Collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

Collaborator

Zealand University Hospital

Collaborator

Lillebaelt Hospital, Kolding and Vejle, Denmark

Collaborator

Gødstrup Hospital

Collaborator

Viborg Regional Hospital

Collaborator

Horsens Hospital

Collaborator

Hospital of Southern Jutland, Aabenraa, Denmark

Collaborator