NCT03741179: StopPRE

Detection of False Positives From First-trimester Preeclampsia Screening (StopPRE) at the Second-trimester of Pregnancy

Completed Phase 3 Last updated 16 February 2022

What this trial tests

Phase 3 trial testing ASA-withdrawn group in Pre-Eclampsia in 974 participants. Completed in 30 January 2022.

Timeline

20 August 2019

Primary endpoint
30 January 2022

30 January 2022

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	974
Start date	20 August 2019
Primary completion	30 January 2022
Estimated completion	30 January 2022
Sites	1 location across Spain

Drugs / interventions tested

• ASA-withdrawn group — full drug profile →

Conditions studied

• Pre-Eclampsia — all drugs for Pre-Eclampsia →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

18 and older, female only, with Pre-Eclampsia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pregnant women at a higher risk for pre-eclampsia (PE) should be offered preventive daily treatment with acetylsalicylic acid (ASA) started before 16 weeks of gestation. To select patients at higher risk for PE, multiparametric assessment combining maternal history, biochemical factors and biophysical factors should be used during the first trimester of pregnancy. Multiparametric risk assessments have a detection rate for early-onset PE around 80% at a false positive rate of 10%. Owing to the low prevalence of early-onset and preterm PE, more than 90% of patients considered at high risk, at the first-trimester screening, will not eventually develop PE. Thus, ASA treatment would be innecessary and could be safely discontinued in these patients.

The sFlt-1 to PlGF ratio has a high negative predictive value for PE during the second and third trimester of pregnancy. Thus, it could be used to detect false-positive patients from the first-trimester screening.

This is a multicentric, randomized, open, parallel, controlled, phase III trial, where 1,080 patients under treatment with ASA for being at high risk for preeclampsia from the first-trimester screening, will be candidates to participate. Patients with a sFlt-1/PlGF \<38, from 24 to 27+6 weeks of gestation will be randomized at a 1:1 ratio and allocated to either continue ASA until 36 weeks or to stop ASA treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Aspirin Discontinuation at 24 to 28 Weeks' Gestation in Pregnancies at High Risk of Preterm Preeclampsia: A Randomized Clinical Trial.
   Mendoza M, Bonacina E, Garcia-Manau P, López M, et al · · 2023 · cited 34× · PMID 36809321 · DOI 10.1001/jama.2023.0691
2. Placental growth factor at 24-28 weeks for aspirin discontinuation in pregnancies at high risk for preterm preeclampsia: Post hoc analysis of StopPRE trial.
   Ricart M, Bonacina E, Garcia-Manau P, López M, et al · · 2024 · cited 3× · PMID 39171611 · DOI 10.1111/aogs.14955