PREPARE, Prematurity Reduction by Pre-eclampsia Care

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.

Conditions

• Pre-Eclampsia
• Premature Birth

Interventions

DIAGNOSTIC_TEST

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

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.

Sponsors & Collaborators

• CoLab

  collaborator UNKNOWN

• SMSDC/RJ

  collaborator UNKNOWN

• University of Campinas, Brazil

  collaborator OTHER

• UPECLIN HC FM Botucatu Unesp

  collaborator OTHER

• HGA

  collaborator UNKNOWN

• HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS

  collaborator UNKNOWN

• Hospital de Clinicas de Porto Alegre

  collaborator OTHER

• Instituto Fernandes Figueira

  lead OTHER_GOV

Principal Investigators

• Marcos A Dias, PhD · Instituto Fernandes Figueira

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

10 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-12-01

Primary Completion

2019-12-30

Completion

2020-06-20

Countries

• Brazil

Study Locations