Optimizing the Use of Aspirin for the Prevention of Preeclampsia

Starting soon · Phase 3

Conditions studied: Preeclampsia

In brief

Pregnant women at higher risk for preeclampsia (PE) are currently recommended to take low-dose aspirin (acetylsalicylic acid, ASA) daily from the first trimester until 36 weeks of gestation. High-risk women are identified through a multiparametric first-trimester screening that combines maternal history, blood pressure, uterine artery blood flow, and placental growth factor (PlGF). Although this screening effectively identifies women at risk, the majority of those classified as high risk will not develop PE. As a result, a large proportion of pregnant women receive prolonged aspirin treatment without benefit, while remaining exposed to its potential side effects, including increased bleeding risk. Aspirin prevents PE primarily by improving placental development during the first half of pregnancy. Whether continuing ASA beyond 24-28 weeks provides additional protection remains unclear. A previous randomized trial demonstrated that stopping ASA at 24-28 weeks was non-inferior to continuing until 36 weeks in a predominantly European population. However, whether this finding applies to more diverse populations, including women of African origin who carry a substantially higher baseline risk of PE, has not been established. This is a multicenter, randomized, open-label, parallel-group, phase III non-inferiority trial conducted across sites in Europe and Africa. A total of 15,160 pregnant women at high risk for PE from first-trimester screening, currently under ASA treatment, will be randomized in a 1:1 ratio before 28 weeks of gestation to either discontinue ASA at 24-28 weeks or continue ASA until 36 weeks of gestation.

Key facts

Study ID

NCT07665853

Run by

Hospital Universitari Vall d'Hebron Research Institute

People needed

15160

Starts

2026-07-01

Expected to finish

2028-05-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older at time of enrollment.
• Singleton pregnancy.
• Ability to read and understand the informed consent form.
• Having undergone first-trimester preeclampsia screening between 11+0 and 13+6 weeks of gestation using a validated multiparametric algorithm (FMF algorithm at a risk cutoff of 1:100, or Gaussian algorithm at a cutoff of 1:170) and being classified as high risk for preterm preeclampsia.
• Currently taking aspirin 150 mg/day initiated after first-trimester high-risk classification, in accordance with standard clinical practice.
• Voluntary signing of the informed consent form and willingness to comply with the study requirements, including acceptance of the assigned aspirin treatment duration, additional blood tests, and additional ultrasound assessments.

You may not qualify if…

• Early pregnancy loss, intrauterine fetal death, or fetus with major structural malformations diagnosed at the time of enrollment.
• Fetus affected by a known genetic or chromosomal disease.
• Contraindication, allergy, or intolerance to aspirin (acetylsalicylic acid).
• Any medical condition that makes aspirin discontinuation unsafe or impossible (e.g., antiphospholipid syndrome, mechanical heart valve, or other conditions requiring indefinite antiplatelet or anticoagulant therapy).

Where it is running

• Medical University of Vienna — Vienna, Austria
• St Josef Hospital — Vienna, Austria
• Dr Shterev Hospital — Sofia, Bulgaria
• Saint Patrick Hospital — Ofinso, Ghana
• Holy Family Hospital — Techiman, Ghana
• Hopital Phillipe Senghor — Dakar, Senegal
• Centre Hospitalier Régional de Saint-Louis — Saint-Louis, Senegal
• Hospital San Cecilio — Granada, Andalusia, Spain
• Hospital Universitari Dexeus — Barcelona, BARCELONA, Spain
• Hospital Dr.Josep Trueta — Girona, Girona, Spain
• Hospital Joan XXIII — Tarragona, Tarragona, Spain
• Hospital de Cruces — Barakaldo, Vizcaya, Spain
• Complejo Hospitalario Universitario de A Coruña — A Coruña, Spain
• Hospital General de Alicante — Alicante, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Universitari Vall d'Hebrón — Barcelona, Spain
• Hospital Universitario de Burgos — Burgos, Spain
• Hospital Universitario Puerta del Mar — Cadiz, Spain
• Hospital Universitario Virgen de las Nieve — Granada, Spain
• Hospital Universitario de Jerez — Jerez de la Frontera, Spain
• Hospital Materno Infantil de Gran Canaria — Las Palmas de Gran Canaria, Spain
• Hospital Universitario Severo Ochoa — Leganés, Spain
• Hospital de León — León, Spain
• Hospital Arnau de Vilanova de Lleida — Lleida, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.