A phase III, multicentric, Randomized, open-label, parallel-group clinical trial to detect false positives from first-trimester preeclampsia screening (StopPRE) at the second-trimester of pregnancy.

Phase 1

• Conditions: First-trimester pre-eclampsia patients; MedDRA version: 20.0Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-000811-26-ES
• Lead Sponsor: Vall D'Hebron Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-09
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1080

Inclusion Criteria

- Patients older than 18 years old
- Gestational period less than 28+0 weeks
- Unique gestation
- High-risk of pre-eclampsia for the first-trimester screening, defined through a validated multivariate algorithm for the population under study
- AAS initiation taken = 16 + 6 weeks of pregnancy
- Ratio sFlt1 / PlGF determined between the weeks of pregnancy 24-27 + 6
- Voluntary signature of the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1134
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Multiple gestation
- Dead and/or multiple malformation fetus, including also any genetical and/or cromosomical disseas affected by the fetus.
- Von Willebrand dissease.
- 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.
- AAS compliance <50% up to the current visit
- Antiphospholipid syndrome
- No signature of the informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified