Prevention of Preeclampsia in Denmark: A National Implementation Study

NCT07485140 | Recruiting

• 1 other identifier: F-24005144
• Study Type: observational
• Target: 80,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Preeclampsia (PE)

Keywords

Prevention; Screening; Preeclampsia

Outcome Measures

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.

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

Secondary Outcomes (10)

• Incidence of Early Preeclampsia (<34 Weeks' Gestation)

  From first-trimester assessment until delivery.

• Incidence of Preterm Delivery (<32, <34, and <37 Weeks' Gestation)

  Pregnancy through delivery

• Fetal growth restriction and stillbirth

  Pregnancy through delivery.

• Neonatal Intensive Care Unit (NICU) Admission

  At delivery/birth

• Screening Uptake

  Through study completion, an average of 2 years

Study Arms (1)

First trimester screening for preeclampsia

Other: First trimester screening for preeclampsia

Interventions

First trimester screening for preeclampsia OTHER

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

First trimester screening for preeclampsia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lillebaelt Hospital, Kolding and Vejle, Denmark: collaborator
• Gødstrup Hospital: collaborator
• Viborg Regional Hospital: collaborator
• Horsens Hospital: collaborator
• Hospital of Southern Jutland, Aabenraa, Denmark: collaborator
• Copenhagen University Hospital at Herlev: lead
• Aarhus University Hospital Skejby: collaborator
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator
• Copenhagen University Hospital Nordsjælland: 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

Study Sites (3)

Aarhus University

Aarhus, 8200, Denmark

RECRUITING

University of Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

University of Copenhagen

Hillerød, 3400, Denmark

RECRUITING

Related Publications (5)

• O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, de Alvarado M, Carbone IF, Dutemeyer V, Fiolna M, Frick A, Karagiotis N, Mastrodima S, de Paco Matallana C, Papaioannou G, Pazos A, Plasencia W, Nicolaides KH. Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations. Ultrasound Obstet Gynecol. 2017 Jun;49(6):756-760. doi: 10.1002/uog.17455.

  PMID: 28295782 BACKGROUND

• Wright D, Rolnik DL, Syngelaki A, de Paco Matallana C, Machuca M, de Alvarado M, Mastrodima S, Tan MY, Shearing S, Persico N, Jani JC, Plasencia W, Papaioannou G, Molina FS, Poon LC, Nicolaides KH. Aspirin for Evidence-Based Preeclampsia Prevention trial: effect of aspirin on length of stay in the neonatal intensive care unit. Am J Obstet Gynecol. 2018 Jun;218(6):612.e1-612.e6. doi: 10.1016/j.ajog.2018.02.014. Epub 2018 Mar 2.

  PMID: 29505771 BACKGROUND

• Riishede I, Rode L, Sperling L, Overgaard M, Ravn JD, Sandager P, Skov H, Wagner SR, Norgaard P, Clausen TD, Jensen CAJ, Pihl K, Jorgensen FS, Munk JK, Zingenberg HJ, Pedersen NG, Andersen MR, Wright A, Wright D, Tabor A, Ekelund CK. Pre-eclampsia screening in Denmark (PRESIDE): national validation study. Ultrasound Obstet Gynecol. 2023 Jun;61(6):682-690. doi: 10.1002/uog.26183. Epub 2023 May 5.

  PMID: 36840981 BACKGROUND

• O'Gorman N, Wright D, Poon LC, Rolnik DL, Syngelaki A, Wright A, Akolekar R, Cicero S, Janga D, Jani J, Molina FS, de Paco Matallana C, Papantoniou N, Persico N, Plasencia W, Singh M, Nicolaides KH. Accuracy of competing-risks model in screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation. Ultrasound Obstet Gynecol. 2017 Jun;49(6):751-755. doi: 10.1002/uog.17399. Epub 2017 May 14.

  PMID: 28067011 BACKGROUND

• Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

  PMID: 28657417 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Charlotte Kvist Ekelund, Consultant, ass. prof., MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Kvist Ekelund, Consultant, ass. prof. PhD

CONTACT

+45 28265042; charlotte.kvist.ekelund@regionh.dk

Iben Riishede, MD, PhD

CONTACT

+45 21701481; ichr0089@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 20, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

DK (3)