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
This trial accepts healthy volunteersQualifiers
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 population
The study population consists of pregnant women in Denmark who participate in the routine first-trimester screening program for chromosomal abnormalities performed at public maternity hospitals. The cohort is therefore drawn from the general pregnant population receiving antenatal care within the Danish public healthcare system.
Trial design
Cohort
Prospective
Treatments tested in this trial
First trimester screening for preeclampsia
Other interventionScreening for preeclampsia using maternal factors, Mean arterial pressure, flow in the uterine arteries and Placental Growth Factor
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Preterm Preeclampsia (<37 Weeks' Gestation)
Proportion of pregnancies complicated by preeclampsia with delivery before 37+0 weeks' gestation. Preeclampsia will be defined according to the 2018 International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria. Cases will be identified using mandatory ICD-10 diagnosis codes recorded in the Danish National Patient Register and linked with gestational age at delivery from the Danish Medical Birth Register. The outcome will be assessed at the population level comparing baseline and implementation periods.
Secondary outcomes
Incidence of Early Preeclampsia (<34 Weeks' Gestation)
Proportion of pregnancies complicated by preeclampsia with delivery before 34+0 weeks' gestation, defined according to ISSHP 2018 criteria and identified through national health register data and gestational age at delivery.
Incidence of Preterm Delivery (<32, <34, and <37 Weeks' Gestation)
Proportion of pregnancies resulting in delivery before 32+0, 34+0, and 37+0 weeks' gestation, regardless of cause. Gestational age at delivery will be obtained from the Danish Medical Birth Register and compared across baseline and implementation periods.
Fetal growth restriction and stillbirth
Occurrence of fetal growth restriction as defined by registry-based diagnosis codes and/or birthweight below gestational age-specific reference standards recorded in the Danish Medical Birth Register and National Patient Register. Stillbirth recorded in the Danish Medical Birth Register according to national definitions and registry coding.
Neonatal Intensive Care Unit (NICU) Admission
Any admission to a neonatal intensive care unit recorded in national registry data, including duration of admission where available.
Sponsors and contacts
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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