Premature BirthPRETURNNCT03405116
Prediction Tool for Premature Labour and Neonatal Outcome
An observational study of Premature Birth, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
A register and prediction model will be developed to predict the outcome of preterm labour and birth. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- How many people
- 2,037 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2017to Dec 2032
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Women visiting the maternity ward suffering from symptoms of preterm birth.
Who may be able to join
- Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Premature Birth
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2017 - 2030
Secondary outcomes (1)
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
Measured: 2012-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jul 2017
- Primary completion1 May 2023
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,037 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristien Roelens, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405116
- Sponsor's protocol ID
- B670201732321 (BC-00466)
- Acronym
- PRETURN
- Status last verified
- May 2024
- First submitted
- 23 Nov 2017
- Last updated
- 30 May 2024
- Results posted
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal and Long Term Outcomes of Preterm Born Children in Flanders
- ClinicalTrials.gov ID
- NCT03405116
- Acronym / sponsor ID
- PRETURN / B670201732321 (BC-00466)
- Conditions
- Premature Birth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,037 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- Dec 2032 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A register and prediction model will be developed to predict the outcome of preterm labour and birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women visiting the maternity ward suffering from symptoms of preterm birth.
Key inclusion criteria (1 listed)
- Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Register
Time frame: 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
Prediction model
Time frame: 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.
1 secondary outcome
The interval between starting corticosteroids and delivery
Time frame: 2012-2020
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 32621250Dehaene 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristien Roelens, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Register (time frame: 2017 - 2030). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.