Prevention of Preeclampsia in Denmark: A National Implementation Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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

Primary outcome measure(s)

• Incidence of Preterm Preeclampsia (<37 Weeks' Gestation) — From first-trimester assessment (11-14 weeks' gestation) until delivery
  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.

Trial sites (3)

More Copenhagen University Hospital at Herlev trials in Denmark