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Optimizing the Use of Aspirin for the Prevention of Preeclampsia

NCT07665853 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15160

Last updated 2026-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Fetal Medicine Foundation

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Manel Mendoza Cobaleda, Professor · Hospital Universitari Vall Hebron - Vall Hebrón Institut de Recerca

  • Kypros Nicolaides, Professor · Fetal Medicine Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • Austria
  • Bulgaria
  • Ghana
  • Senegal
  • Spain
  • The Gambia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07665853 on ClinicalTrials.gov