- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405116
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
- Name: Isabelle Dehaene, MD
- Phone Number: +23 9 332 57 64
- Email: isabelle.dehaene@UGent.be
Study Contact Backup
- Name: Sara Somers
- Email: Sara.Somers@uzgent.be
Study Locations
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Ghent, Belgium, 9000
- Ghent University Hospital - Women's Clinic
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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
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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
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2017 - 2030
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Prediction model
Time Frame: 2017 - 2030
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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.
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2017 - 2030
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The interval between starting corticosteroids and delivery
Time Frame: 2012-2020
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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
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2012-2020
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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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