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Prevention of Preeclampsia in Denmark (PREPRED): A National Implementation Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Denmark
Aarhus University
RECRUITING
Aarhus
University of Copenhagen
RECRUITING
Copenhagen
University of Copenhagen
RECRUITING
Hillerød
Contact Information
Primary
Charlotte Kvist Ekelund, Consultant, ass. prof. PhD
charlotte.kvist.ekelund@regionh.dk
+45 28265042
Backup
Iben Riishede, MD, PhD
ichr0089@regionh.dk
+45 21701481
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-11
Participants
Target number of participants: 80000
Treatments
First trimester screening for preeclampsia
Related Therapeutic Areas
Sponsors
Collaborators: Bornholm Hospital, Denmark, Lillebaelt Hospital, Kolding and Vejle, Denmark, Slagelse Hospital, Viborg Regional Hospital, Zealand University Hospital, Odense University Hospital, Hospital of Southern Jutland, Aabenraa, Denmark, Esbjerg Hospital - University Hospital of Southern Denmark, Nykøbing Falster County Hospital, Gødstrup Hospital, Nordsjaellands Hospital, Horsens Hospital, Aalborg University Hospital, Copenhagen University Hospital, Hvidovre, Aarhus University Hospital Skejby, Holbaek Sygehus
Leads: Copenhagen University Hospital at Herlev

This content was sourced from clinicaltrials.gov