Prediction Tool for Premature Labour and Neonatal Outcome

Premature Birth Clinical Trial

— PRETURN  

Official title:

Neonatal and Long Term Outcomes of Preterm Born Children in Flanders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03405116
• Other study ID #: B670201732321
• Status: Active, not recruiting
• Start date: July 1, 2017
• Est. completion date: December 2032

Study information

• Verified date: August 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12000
• Est. completion date: December 2032
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
Belgium	Ghent University Hospital - Women's Clinic	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The interval between starting corticosteroids and delivery	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