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

NCT03741179 | Completed Phase 3 DMC

• 2 other identifiers: STOPPRE2018-000811-26
• Study Type: interventional
• Target: 974
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Eclampsia

Keywords

pre-eclampsia; pregnant; sFlt-1/PlGF ratio; ASA treatment

Outcome Measures

Primary Outcomes (1)

• Rate of preterm pre-eclampsia 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 and ratio sFlt-1/PlGF\<38 between 24-27+6 weeks of gestation in both arms of the study (ASA vs no ASA).

  From 24+0 weeks of gestation onwards

Study Arms (2)

ASA-withdrawn group

EXPERIMENTAL

ASA treatment will be withdrawn if patients present an sFlt/PlGF \< 38 at 24+0-27+6 weeks of gestation.

Drug: ASA-withdrawn group

ASA group

NO INTERVENTION

ASA treatment will continue until 36 weeks of gestation if patients present an sFlt/PlGF ratio \< 38 at 24+0-27+6 weeks of gestation.

Interventions

ASA-withdrawn group DRUG

Patients whith sFlt/PlGF ratio \< 38 at 24+0-27+6 weeks will be randomized into two arms of the trial. Patients allocated in the experimental arm will stop the ASA treatment.

Also known as: sFlt y PlGF ratio less than 38.

ASA-withdrawn group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old
• Gestational age between 24+0 and 27+6 weeks
• Single pregnancy
• High-risk for pre-eclampsia from the first-trimester screening for pre-eclampsia
• ASA treatment started before or at 16+6 weeks of gestation
• Maternal sFlt-1/PlGF ratio at 24+0-27+6 weeks of gestation
• Signed informed consent

You may not qualify if:

• Multiple pregnancy
• Dead and/or fetal polymalformation, including also any fetal genetical and/or chromosomic disease.
• Von Willebrand disease.
• ASA intolerance and /or allergy
• Peptic ulcer
• Patients with misunderstanding or not able to understand the protocol, including also any condition which could compromise the compliance of the protocol, according to the investigator's opinion.
• No signature of the informed consent

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (1)

• Mendoza M, Bonacina E, Garcia-Manau P, Lopez M, Caamina S, Vives A, Lopez-Quesada E, Ricart M, Maroto A, de Mingo L, Pintado E, Ferrer-Costa R, Martin L, Rodriguez-Zurita A, Garcia E, Pallarols M, Vidal-Sagnier L, Teixidor M, Orizales-Lago C, Perez-Gomez A, Ocana V, Puerto L, Millan P, Alsius M, Diaz S, Maiz N, Carreras E, Suy A. Aspirin Discontinuation at 24 to 28 Weeks' Gestation in Pregnancies at High Risk of Preterm Preeclampsia: A Randomized Clinical Trial. JAMA. 2023 Feb 21;329(7):542-550. doi: 10.1001/jama.2023.0691.

  PMID: 36809321 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Manel Mendoza Cobaleda, MD, PhD

  Vall d'Hebron Institut de Recerca (VHIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A phase III, multicentric, Randomized, open-label, parallel-group clinical trial

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 14, 2018
• Study Start: August 20, 2019
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

ES (1)