CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,250 enrolled
Drug / intervention
FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03073317
NCT03073317N/ACompleted
CompareCT.gov

PREPARE, Prematurity Reduction by Pre-eclampsia Care

Instituto Fernandes Figueira·interventional·Posted Mar 8, 2017·Updated Jul 18, 2023

In Brief

A clinical study evaluating FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio) for Pre-Eclampsia and Premature Birth. Completed, enrolled 1,250 participants across 8 sites.

Detailed Summary

Investigators will test a novel system of integrated care, to promote the use of the WORLD HEALTH ORGANIZATION Guidelines for the management of pre-eclampsia and initiate the use of a structured risk assessment strategy to reduce the incidence of preterm delivery from pre-eclampsia by providing obstetricians with the confidence to safely defer delivery of women with pre-eclampsia, identified to be of low risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-Eclampsia, Premature Birth
CountriesBrazil
CollaboratorsCoLab, SMSDC/RJ, University of Campinas, Brazil, UPECLIN HC FM Botucatu Unesp, HGA, HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS, Hospital de Clinicas de Porto Alegre

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 8, 2017
Enrollment StartDec 1, 2016
Primary CompletionDec 30, 2019
Study CompletionJun 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.3 years ago

Interventions

FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)other

Once the centre is randomised to receive the intervention, all eligible women will have serum sFlt1/PlGF measurement performed and fullPIERS assessment and both results will be revealed to the care providers. This will include all women with pre-eclampsia or suspected pre-eclampsia cared for at the main hospital centres (and not be limited to women referred to the hospital from the community health centres). sFlt-1/PlGF will be tested by immunoassays (Roche Platform®). The result read out is provided by specific machines provided by Roche in less than one hour, which permits rapid clinical decision-making. Risk stratification using fullPIERS will be performed on tablet computers using a pre-defined risk scoring system integrated within the MedSciNet database.