Prediction Tool for Premature Labour and Neonatal Outcome

Active, not recruiting

• Conditions: Premature Birth

• Registration Number: NCT03405116
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Primary Completion: 2023-05-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2037

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction model	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.
Register	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

Secondary Outcome Measures

Name	Time	Method
The interval between starting corticosteroids and delivery	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

Trial Locations

Locations (1)

Ghent University Hospital - Women's Clinic; 🇧🇪 Ghent, Belgium