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Optimizing the Use of Aspirin for the Prevention of Preeclampsia
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Summary
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 Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15160
Start Date
2026-07-01
Completion Date
2028-05
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
Discontinuation of Acetylsalicilic acid 150 mg/day at 24-28 weeks of gestation
Intervention group will discontinuate of Acetyl Salicylic acid at 24-28 weeks of gestation while Control Group will continue Acetyl Salicylic acid 150 mg/day until 36 weeks of gestation.
Locations (38)
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
Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Consorci Sanitari de Terrassa
Terrassa, Spain
Hospital Universitari Mútua Terrassa
Terrassa, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Spain
Bundung Maternal and Child Health Hospital
Banjul, The Gambia
Brikama District Hospital
Brikama, The Gambia
King's College Hospital
London, United Kingdom
Medway Maritime Hospital
London, United Kingdom