Active, not recruitingNCT03405116PRETURNUpdated May 30, 2024

Prediction Tool for Premature Labour and Neonatal Outcome

An observational study in Premature Birth, sponsored by University Hospital, Ghent. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by University Hospital, Ghent · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 2,037
Ages: 18 Years to 50 Years
Sex: All

Study summary

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

Conditions studied

Premature Birth

Browse trials for

Premature Birth 2,546

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 2,037 participants (actual)
Target follow-up: 4 Years
Patient registry: Yes

What researchers measure

Primary outcomes

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
Time frame: 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.
Time frame: 2017 - 2030

Secondary outcomes

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
Time frame: 2012-2020

Study locations

1 site

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

References and documents

Publications

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. PubMed 32621250 ↗

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03405116
Lead sponsor: University Hospital, Ghent
Responsible party: Sponsor
First posted: Jan 19, 2018
Start date: Jul 1, 2017
Primary completion: May 1, 2023
Completion: Dec 2032 (estimated)
Last update: May 30, 2024

Study contacts

Kristien Roelens, MD, PhD

principal investigator · University Hospital, Ghent

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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