Optimizing Aspirin Use for Preeclampsia Prevention

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Not possible to specify

Decision date (initial)

2026-05-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To evaluate whether stopping ASA between weeks 24 and 26 is non-inferior in preventing preterm preeclampsia compared to the control group, which will continue ASA until week 36

Secondary objectives 2

1. To evaluate whether stopping ASA does not increase maternal, fetal, or neonatal morbidity or mortality.
2. To evaluate whether stopping ASA reduces the risk of maternal bleeding.

Conditions and MedDRA coding

Obstetrics – Preeclampsia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients older than 18 years
2. Ability to read and understand the informed consent
3. Singleton pregnancy
4. Having undergone first-trimester preeclampsia screening (11+0 to 13+6 weeks) using a multiparametric algorithm and being classified as high risk.
5. Voluntary informed consent signature and willing to comply with study protocol (including acceptance of aspirin [ASA] treatment, additional blood tests and ultrasounds, and the assigned treatment duration at randomization).

Exclusion criteria 4

1. Early pregnancy loss, stillbirth or fetus with major malformations
2. Fetus affected by a known genetic or chromosomal disease
3. Contraindication, allergy, or intolerance to aspirin (AAS)
4. Inability to discontinue aspirin (e.g., antiphospholipid syndrome, etc.)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To assess whether ASA discontinuation at 24–26 weeks is non-inferior in preventing preterm PE compared with the control group, who will continue ASA until 36 weeks.

Secondary endpoints 7

1. To assess whether ASA discontinuation does not increase maternal, fetal, or neonatal morbidity or mortality.
2. To assess whether ASA discontinuation discontinuing aspirin treatment reduces the risk of maternal hemorrhage
3. Carry out a comprehensive clinical and economic analysis to assess the cost-effectiveness of the screening program and the incremental value of incorporating specific markers (PlGF, UtA-PI, and ophthalmic artery Doppler) in different socioeconomic contexts.
4. Determine optimized risk thresholds specific to each population and performance metrics that facilitate the translation into evidence based policies and resource allocation in both European and African healthcare systems.
5. Compare different methods for determining the placental growth factor (PlGF): point-of-care devices versus ELISA/ECLIA.
6. To evaluate the role of the ophthalmic artery in the prediction of preeclampsia (PE).
7. Develop models using clinical data, ultrasound markers, and biomarkers to predict cases that will develop preeclampsia despite adequate treatment with ASA.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Sponsor organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Address

Passeig De La Vall D'Hebron 119-129

City

Barcelona

Postcode

08035

Country

Spain

Scientific contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Manel Mendoza Cobaleda

Public contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Manel Mendoza Cobaleda

Locations

1 EU/EEA country · 23 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications