Optimizing the Use of Aspirin for the Prevention of Preeclampsia

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT07665853
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Discontinuation of Acetylsalicilic acid 150 mg/day at 24-28 weeks of gestation — DRUG
    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.

Study Details

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 Dates

First listed
Jun 24, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
15,160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ASA withdrawn group
    ASA is discontinued at 24-28 weeks of gestation
  • No Intervention: Continue ASA Group
    ASA is continued until 36 weeks of gestation

Primary Outcome Measure

Rate of preterm preeclampsia in both arms of the study (ASA vs no ASA). [ Time Frame: From 20 weeks of gestation onwards ]

Central Contacts

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