PreeclampsiaPRERISKNCT06200571
Biological Changes Associated With High Risk of Preeclampsia in Nulliparous Women
An observational study of Preeclampsia, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
Primary outcome 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 2 sitesNorway
- Study dates
- 22 May 2024to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nulliparous women with low and high risk for preeclampsia, defined by FMF-screening in week 11-14 of pregnancy
Who may be able to join
- 18 years or older
- nulliparous women
- singleton live fetus
- FMF risk > 1/100 (high risk), or < 1/150 (low risk)
Who cannot join
- not speaking Norwegian or English language
- fetal anomalies diagnosed with ultrasound
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Characterization of the Immunological and Vascular Effects of Aspirin in Prevention of Preeclampsia in High-risk Nulliparous Women
Primary outcome
- to identify biological changes in nulliparous women at high risk for preeclampsia defined by combined screening by Fetal Medicine Foundation (FMF)
- to identify biological effects of aspirin in nulliparous women with high risk for preeclampsia
Read more
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.
Read the detailed description
St. Olavs Hospital offers FMF-screening in week 11-14 and aspirin treatment through the "Implementing Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks - a Randomized Controlled Trial" (NCT06108947). FMF-screening and aspirin treatment are not part of routine clinical care at Alesund Hospital according to current recommendations from the Norwegian health authorities. Alesund Hospital will therefore perform FMF-screening only to determine the project specific study groups. Researchers will compare the three groups to identify biological changes associated with high risk for preeclampsia and the effect of aspirin.
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
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal serum cytokine profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Maternal serum cytokine profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Secondary outcomes (14)
Maternal serum metabolite profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Maternal serum lipid profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Maternal serum metabolite profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Maternal serum lipid profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Maternal vascular malperfusion in the placenta
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Fetal vascular malperfusion in the placenta
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Maternal vascular malperfusion in the placenta
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Fetal vascular malperfusion in the placenta
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Fetal cord serum cytokine profile
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Fetal cord serum metabolite profile
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Fetal cord serum lipid profile
Significant difference between low and high-risk pregnancies defined by FMF-screening
Measured: December 2028
Fetal cord serum cytokine profile
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Fetal cord serum metabolite profile
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Fetal cord serum lipid profile
Significant difference between high-risk pregnancies with and without aspirin
Measured: December 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start22 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Alesund Hospital, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Ann-Charlotte Iversen, Professor, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200571
- Sponsor's protocol ID
- 537602
- Acronym
- PRERISK
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It may be necessary to include other researchers for planned analysis of the biological materials, for instance for pathological classification of placental tissue. Limited individual clinical information such as diagnosis and gestational age at delivery may be shared, but only in deidentified form. When publishing research findings from the project in international peer-reviewed journals, it may be required to publish individual research data along with very limited clinical information in a repository, but only in anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Immunological and Vascular Effects of Aspirin in Prevention of Preeclampsia in High-risk Nulliparous Women
- ClinicalTrials.gov ID
- NCT06200571
- Acronym / sponsor ID
- PRERISK / 537602
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Alesund Hospital, St. Olavs Hospital
- Study start
- 22 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary outcome
- to identify biological changes in nulliparous women at high risk for preeclampsia defined by combined screening by Fetal Medicine Foundation (FMF)
- 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.
Detailed description
St. Olavs Hospital offers FMF-screening in week 11-14 and aspirin treatment through the "Implementing Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks - a Randomized Controlled Trial" (NCT06108947). FMF-screening and aspirin treatment are not part of routine clinical care at Alesund Hospital according to current recommendations from the Norwegian health authorities. Alesund Hospital will therefore perform FMF-screening only to determine the project specific study groups. Researchers will compare the three groups to identify biological changes associated with high risk for preeclampsia and the effect of aspirin.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nulliparous women with low and high risk for preeclampsia, defined by FMF-screening in week 11-14 of pregnancy
Key inclusion criteria (4 listed)
- 18 years or older
- nulliparous women
- singleton live fetus
- FMF risk > 1/100 (high risk), or < 1/150 (low risk)
Key exclusion criteria (2 listed)
- not speaking Norwegian or English language
- fetal anomalies diagnosed with ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal serum cytokine profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Time frame: December 2028
Significant difference between low and high-risk pregnancies defined by FMF-screening
Maternal serum cytokine profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Time frame: December 2028
Significant difference between high-risk pregnancies with and without aspirin
14 secondary outcomes
Maternal serum metabolite profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Time frame: December 2028
Maternal serum lipid profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Time frame: December 2028
Maternal serum metabolite profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Time frame: December 2028
Maternal serum lipid profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
Time frame: December 2028
Maternal vascular malperfusion in the placenta
Time frame: December 2028
Fetal vascular malperfusion in the placenta
Time frame: December 2028
Maternal vascular malperfusion in the placenta
Time frame: December 2028
Fetal vascular malperfusion in the placenta
Time frame: December 2028
Fetal cord serum cytokine profile
Time frame: December 2028
Fetal cord serum metabolite profile
Time frame: December 2028
Fetal cord serum lipid profile
Time frame: December 2028
Fetal cord serum cytokine profile
Time frame: December 2028
Fetal cord serum metabolite profile
Time frame: December 2028
Fetal cord serum lipid profile
Time frame: December 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Cytokine patterns in maternal serum from first trimester to term and beyondLink provided by the sponsor.
- Metabolomic biomarkers in serum and urine in women with preeclampsiaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. It may be necessary to include other researchers for planned analysis of the biological materials, for instance for pathological classification of placental tissue. Limited individual clinical information such as diagnosis and gestational age at delivery may be shared, but only in deidentified form. When publishing research findings from the project in international peer-reviewed journals, it may be required to publish individual research data along with very limited clinical information in a repository, but only in anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann-Charlotte Iversen, Professor study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal serum cytokine profile in week 11-13, 22-24, 32 and 38 and 6 months post partum (time frame: December 2028). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.