NCT07485140 Prevention of Preeclampsia in Denmark: A National Implementation Study

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 80,000 participants in total. It began in 2025-09-15 with a primary completion date of 2027-11.

Brief 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 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

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