A Phase 3 interventional study of Discontinuation of Acetylsalicilic acid 150 mg/day at 24-28 weeks of gestation in Preeclampsia, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 38 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 3, Interventional, and Prevention
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.
The primary objective of the study is to demonstrate that in pregnant women at high risk for preeclampsia from first-trimester multiparametric screening, the incidence of preterm PE after discontinuation of ASA at 24-28 weeks of gestation is non-inferior to that of the control group, who continue ASA until 36 weeks.
Exclusion Criteria:
ASA is discontinued at 24-28 weeks of gestation
Drug: Discontinuation of Acetylsalicilic acid 150 mg/day at 24-28 weeks of gestation
ASA is continued until 36 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.
Rate of preterm preeclampsia in both arms of the study (ASA vs no ASA).
Rate of pre-eclampsia \<37 weeks in pregnant women at high-risk for early-onset PE from the first-trimester screening in both arms of the study (ASA vs no ASA).
Time frame: From 20 weeks of gestation onwards
Plan to share: Yes — Upon publication, anonymized data will be deposited in the VHIR's institutional open research data repository.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute