NCT06200571

Brief Summary

Primary outcome

  • 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started May 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
May 2024Dec 2032

First Submitted

Initial submission to the registry

December 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 22, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

December 8, 2023

Last Update Submit

December 5, 2025

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    December 2028

Secondary Outcomes (14)

  • Maternal serum metabolite profile in week 11-13, 22-24, 32 and 38 and 6 months post partum

    December 2028

  • Maternal serum lipid profile in week 11-13, 22-24, 32 and 38 and 6 months post partum

    December 2028

  • Maternal serum metabolite profile in week 11-13, 22-24, 32 and 38 and 6 months post partum

    December 2028

  • Maternal serum lipid profile in week 11-13, 22-24, 32 and 38 and 6 months post partum

    December 2028

  • Maternal vascular malperfusion in the placenta

    December 2028

  • +9 more secondary outcomes

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale, only pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nulliparous women with low and high risk for preeclampsia, defined by FMF-screening in week 11-14 of pregnancy

You may qualify if:

  • years or older
  • nulliparous women
  • singleton live fetus
  • FMF risk \> 1/100 (high risk), or \< 1/150 (low risk)

You may not qualify if:

  • not speaking Norwegian or English language
  • fetal anomalies diagnosed with ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alesund Hospital

Ålesund, 6017, Norway

Location

St. Olavs Hospital

Trondheim, 7030, Norway

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urin, placenta, umbilical cord blood

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ann-Charlotte Iversen, Professor

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2023

First Posted

January 11, 2024

Study Start

May 22, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2032

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Locations

NO(2)