Biological Changes Associated With High Risk of Preeclampsia in Nulliparous Women
NCT ID: NCT06200571
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
200 participants
OBSERVATIONAL
2024-05-22
2032-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. to identify biological changes in nulliparous women at high risk for preeclampsia defined by combined screening by Fetal Medicine Foundation (FMF)
2. to identify biological effects of aspirin in nulliparous women with high risk for preeclampsia
Secondary outcomes include findings of longitudinal development and predictive potential of biological markers associated with high-risk for preeclampsia and aspirin treatment.
The main questions it aims to answer are:
* Is high risk for preeclampsia associated with biological changes during pregnancy?
* How does aspirin modulate the biological changes associated with high risk for preeclampsia?
Nulliparous women will undergo routine clinical care at two regional hospitals with different treatment strategies, and selected to the study in three groups: low risk of preeclampsia, high risk of preeclampsia without aspirin, and high-risk of preeclampsia with aspirin treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
NCT06802861
Aspirin for Prevention of Preeclampsia
NCT03726177
Predictors of Aspirin Failure in Preeclampsia Prevention
NCT05709483
Aspirin 150 mg vs 100 mg for Prevention of Preeclampsia in High-Risk Obese Pregnant Women
NCT06952712
Aspirin for Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women
NCT03725891
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
FMF- screening will be performed in week 11-14 after written, informed consent (approved by the the Regional Committee for Medical and Health Research Ethics in Central Norway (REK-midt), REK 537602). Screening includes patient history, blood pressure, uterine artery mean pulsatile index and serum placenta growth factor (PlGF). Standardized blood pressure will be measured by trained personnel. Ultrasound scans will be performed by FMF certified doctors and midwives working at Alesund Hospital and the Center for Fetal Medicine at St.Olavs Hospital in Trondheim. PlGF in maternal serum will be analyzed with Roche or Kryptor technology.
The investigators will include around 200 women, 18 years or older, with a singleton live fetus, in three groups:
* Nulliparous women with low risk for preeclampsia (at both hospitals)
* Nulliparous women with high risk for preeclampsia without aspirin (at Alesund Hospital)
* Nulliparous women with high risk for preeclampsia with aspirin (at St. Olavs Hospital)
Follow-up: all three groups will have visits in week 22-24, 32 and 38, and standard antenatal care after 37 weeks until delivery. Fetal growth and Doppler will be assessed at the scheduled visits and according to clinical judgement by obstetricians at the outpatient clinic of the hospital. Women will have follow-up 6 months after birth.
Blood and urine will be sampled at five time points for all three groups (week 11-14, 22-24, 32, 38 and 6 months after birth) for biological analyses. Placenta samples and umbilical venous blood will be sampled at delivery.
Biological materials will be investigated to answer the research questions described. Biological changes in serum will be measured as cytokines by multiplex, metabolites by NMR-analysis, and lipids by NMR-analysis. Vascular changes in the placenta will be measured by histopathological evaluation.
The study will be registered in Clinicaltrials.gov
Funding and sponsors: The study is funded by Helse-Midt Norge RHF. The funding source has played no role in design of the study and will have no role in data collection, analyses, interpretation or publication.
Participants: Ann-Charlotte Iversen, professor, Phd, Project leader Åse Turid Rossevatn Svoren, consultant, MD, Phd candidate, Kjell Åsmund Salvesen, professor, MD, PhD, Solveig Bjellmo, consultant, MD, Phd
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nulliparous women with low risk for preeclampsia
Nulliparous women with low risk for preeclampsia by FMF-screening in the first trimester. Follow-up in week 22-24, 32, 36 and 6 months after delivery wtih clinical measurements, ultrasound doppler, blood- and urin samples.
No interventions assigned to this group
Nulliparous women with high risk for preeclampsia without aspirin
Nulliparous women with high risk for preeclampsia by FMF-screening in the first trimester. Follow-up in week 22-24, 32, 36 and 6 months after delivery wtih clinical measurements, ultrasound doppler, blood- and urin samples.
No interventions assigned to this group
Nulliparous women with high risk for preeclampsia with aspirin
Nulliparous women with high risk for preeclampsia by FMF-screening in the first trimester. Follow-up in week 22-24, 32, 36 and 6 months after delivery wtih clinical measurements, ultrasound doppler, blood- and urin samples. Aspirin tablets 150 mg daily in the evening from first trimester to week 36 of pregnancy.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* nulliparous women
* singleton live fetus
* FMF risk \> 1/100 (high risk), or \< 1/150 (low risk)
Exclusion Criteria
* fetal anomalies diagnosed with ultrasound
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alesund Hospital
OTHER
St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ann-Charlotte Iversen, Professor
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alesund Hospital
Ålesund, , Norway
St. Olavs Hospital
Trondheim, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Cytokine patterns in maternal serum from first trimester to term and beyond
Metabolomic biomarkers in serum and urine in women with preeclampsia
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
537602
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.