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

This trial accepts healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • First trimester screening for preeclampsia

    Other intervention

    Screening for preeclampsia using maternal factors, Mean arterial pressure, flow in the uterine arteries and Placental Growth Factor

Treatment groups

80,000 Participants
are divided into 1 treatment group
Group A: First trimester screening for preeclampsia1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From first-trimester assessment (11-14 weeks' gestation) until delivery

Secondary outcomes

1

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.

Time frame
From first-trimester assessment until delivery.
2

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.

Time frame
Pregnancy through delivery
3

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.

Time frame
Pregnancy through delivery.
4

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.

Time frame
At delivery/birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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