Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks

NCT06108947 | Recruiting

• 1 other identifier: 639348
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Study population Around 3500 pregnant women attending a routine ultrasound scan at 11-14 weeks at St. Olavs hospital, Trondheim, Norway. Study period Dec 2023 - Jul 2025 Screening Patient history, blood pressure, uterine artery mean PI and PlGF will be plotted in the FMF algorithm for screening for preeclampsia in the first trimester. Standardized blood pressure will be measured by trained personnel. Ultrasound scans will be performed by FMF certified doctors and midwives working at the Center for Fetal Medicine in Trondheim. Placenta growth factor (PLGF) will be analyzed with Kryptor technology at Center for Laboratory Medicine, St. Olavs hospital. Prophylaxis Women with high risk for preterm preeclampsia (risk \> 1:100) will be offered aspirin prophylaxis 150 mg x 1 from 11-14 weeks to 36 weeks. Women will be offered to participate in a randomized controlled trial (RCT). Study design and participants in the RCT A single center, open label, randomized, noninferiority trial conducted at St. Olavs hospital, Trondheim Norway from Dec 2023 to Jul 2025. The investigators will include around 300 women 18 years or older with a singleton live fetus, gestational age between 24 and 28 weeks, high risk of preterm preeclampsia (\>1/100) in the first trimester screening, aspirin treatment with a dose 150 mg per day initiated at 16+6 weeks of gestation or less until randomization with a adherence of at least 50% and low SFlt-1/PlGF ratio (Kryptor technology with cut-off 66). Randomization and masking Between 24 and 28 weeks of gestation, participants will be randomly designed, with a computer-based system in a 1:1 ratio, to continue aspirin (control group) or discontinue aspirin (intervention group). This is an open-label study without masking of patients or providers. Follow-up Both groups will have visits every 4 weeks between randomization and 36 weeks, and standard antenatal care after 37 weeks until delivery. Treatment adherence will be assessed by patient self-report and tablet count, and fetal growth and Doppler will be assessed at the scheduled visits between randomization and 36 weeks (at 24, 28, 32 and 36 weeks), and according to clinical judgement by obstetricians at the outpatient clinic of the hospital. Women will have a telephone/video link follow-up 1-2 months after birth

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• Number of patients with preterm preeclampsia

  Delivery due to preeclampsia before 37 weeks of gestation

  Pregnancy week 24 to pregnancy week 37

Secondary Outcomes (12)

• Number of patients with preeclampsia before 34 weeks

  Pregnancy week 24 to pregnancy week 34

• Number of patients with preeclampsia after 37 weeks

  Pregnancy week 24 to pregnancy week 42

• Number of patients developing severe gestational hypertension

  Pregnancy week 24 to pregnancy week 42

• Number of patients diagnosed as small for gestational age (10th centile)

  Birthweight at delivery between 24 and 42 weeks

• Number of patients diagnosed as small for gestational age (3rd centile)

  Birthweight at delivery between 24 and 42 weeks

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin 150 mg per day from pregnancy week 12 to 36 - according to current recommendations

Drug: Aspirin

Aspirin discontinuation

EXPERIMENTAL

Discontinuation of Aspirin around 24-28 weeks in low risk women

Drug: Aspirin

Interventions

Aspirin DRUG

Aspirin discontinuation

Also known as: acetyl salicylic acid

Aspirin; Aspirin discontinuation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• singleton live fetus with gestational age between 24 and 28 weeks
• woman with high risk of preterm preeclampsia (\>1/100) in the first trimester screening
• aspirin treatment with a dose 150 mg per day initiated at 16+6 weeks of gestation or less until randomization with adherence of at least 50%
• low SFlt-1/PlGF ratio (Kryptor technology with cut-off 66) measured at 24-28 weeks

You may not qualify if:

• not speaking Norwegian or English language
• fetal anomalies diagnosed with ultrasound
• informed consent for participation in the trial

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St. Olavs hospital

Trondheim, Norway

RECRUITING

Related Publications (1)

• Mendoza M, Bonacina E, Garcia-Manau P, Lopez M, Caamina S, Vives A, Lopez-Quesada E, Ricart M, Maroto A, de Mingo L, Pintado E, Ferrer-Costa R, Martin L, Rodriguez-Zurita A, Garcia E, Pallarols M, Vidal-Sagnier L, Teixidor M, Orizales-Lago C, Perez-Gomez A, Ocana V, Puerto L, Millan P, Alsius M, Diaz S, Maiz N, Carreras E, Suy A. Aspirin Discontinuation at 24 to 28 Weeks' Gestation in Pregnancies at High Risk of Preterm Preeclampsia: A Randomized Clinical Trial. JAMA. 2023 Feb 21;329(7):542-550. doi: 10.1001/jama.2023.0691.

  PMID: 36809321 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Kjell Å Salvesen, Professor

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kjell Å Salvesen, Professor

CONTACT

+47 41240404; pepes@ntnu.no

Hanne Mørch, MD

CONTACT

+47 99229668; hanne.morch@stolav.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 31, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After completion of the study in Dec 2025
• Access Criteria: Contact the principal investigator

Locations

NO (1)