Prediction Tool for Premature Labour and Neonatal Outcome
PRETURN
Neonatal and Long Term Outcomes of Preterm Born Children in Flanders
1 other identifier
observational
2,037
1 country
1
Brief Summary
A register and prediction model will be developed to predict the outcome of preterm labour and birth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 23, 2017
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
ExpectedMay 30, 2024
May 1, 2024
5.8 years
November 23, 2017
May 29, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Register
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
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 Outcomes (1)
The interval between starting corticosteroids and delivery
2012-2020
Eligibility Criteria
Women visiting the maternity ward suffering from symptoms of preterm birth.
You may qualify if:
- Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ghent University Hospital - Women's Clinic
Ghent, 9000, Belgium
Related Publications (1)
Dehaene I, Scheire E, Steen J, De Coen K, Decruyenaere J, Smets K, Roelens K. Obstetrical characteristics and neonatal outcome according to aetiology of preterm birth: a cohort study. Arch Gynecol Obstet. 2020 Oct;302(4):861-871. doi: 10.1007/s00404-020-05673-5. Epub 2020 Jul 3.
PMID: 32621250DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristien Roelens, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2017
First Posted
January 19, 2018
Study Start
July 1, 2017
Primary Completion
May 1, 2023
Study Completion (Estimated)
December 1, 2032
Last Updated
May 30, 2024
Record last verified: 2024-05