Prediction Tool for Premature Labour and Neonatal Outcome (PRETURN)

August 23, 2023 updated by: University Hospital, Ghent

Neonatal and Long Term Outcomes of Preterm Born Children in Flanders

A register and prediction model will be developed to predict the outcome of preterm labour and birth.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital - Women's Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Women visiting the maternity ward suffering from symptoms of preterm birth.

Description

Inclusion Criteria:

  • Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children

Exclusion Criteria:

  • Patients who choose not to participate in the research.
  • Intra-uterine prelabour fetal death.
  • Fetuses or neonates with a major congenital disorder. Major is defined as a disorder that has an impact on neonatal respiratory and cerebral outcome and/or long-term outcome.
  • Postpartum transfer/outborn.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Register
Time Frame: 2017 - 2030
A multicentre, multidisciplinary register will be created to provide a source of valuable information on obstetrical and neonatal practices and link them with obstetrical, neonatal and long-term outcomes of preterm labour and birth
2017 - 2030
Prediction model
Time Frame: 2017 - 2030
The prediction tool for true preterm labour (TPL) will be developed using individual risk factors, symptomatology, tocography, cervical change and a biomarker test, followed by a decision-making model, both based on individual data, evidence and experience.
2017 - 2030

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The interval between starting corticosteroids and delivery
Time Frame: 2012-2020
The interval between administration of antenatal corticosteroids and birth will be assessed and will be related to the short and long term outcome of preterm born children
2012-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Kristien Roelens, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

May 1, 2023

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B670201732321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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