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.

Vall D'Hebron Institut de Recerca (VHIR)0 个研究点目标入组 1,080 人开始时间: 2018年7月9日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

Vall D'Hebron Institut de Recerca (VHIR)