Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
47062 participants
INTERVENTIONAL
2010-01-06
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
NCT05399979
Electrical Inhibition of Human Preterm Contractions
NCT02983240
Comparing Two Methods of Contractions Monitoring for Clinical Decision Making Regarding Treatment Among Pregnant Women With Preterm Contractions.
NCT02875418
Fetal Pulse Oximetry Trial (FOX)
NCT00098709
Evaluation of Maternal Feedback to Shorten Pushing Efforts During Labor
NCT02648867
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Decison support
"Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time.
INFANT software
The decision-support software to be evaluated in INFANT has been designed to run on the K2 data collection system (Guardian®). The data collection system (Guardian®) is a system for managing information from labour monitoring. It displays the CTG on a computer screen alongside other clinical data which are collected as part of routine clinical care. As such, it replaces conventional paper labour notes, the CTG machine and other recording systems for documenting care during labour.
No Decision Support
"No decision-support" - CTGs with no additional interpretation (UK standard care),
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INFANT software
The decision-support software to be evaluated in INFANT has been designed to run on the K2 data collection system (Guardian®). The data collection system (Guardian®) is a system for managing information from labour monitoring. It displays the CTG on a computer screen alongside other clinical data which are collected as part of routine clinical care. As such, it replaces conventional paper labour notes, the CTG machine and other recording systems for documenting care during labour.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* they have a singleton or twin pregnancy
* they are ≥ 35 weeks' gestation (≥ 245 days)
* there is no known gross fetal abnormality, including any known fetal heart arrhythmia such as heart block
* they are 16 years of age or older
* they are able to give consent to participate in the trial as judged by the attending clinicians.
Exclusion Criteria
* criteria for EFM not met, including elective caesarean section prior to the onset of labour
16 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oxford
OTHER
University of Birmingham
OTHER
University of Plymouth
OTHER
University of Leicester
OTHER
National Childbirth Trust
UNKNOWN
K2 Medical Systems
UNKNOWN
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Brocklehurst, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rotunda
Dublin, , Ireland
Lancashire Women's and Newborn Centre
Burnley, Lancs, United Kingdom
Birmingham Women's Hospital
Birmingham, , United Kingdom
Royal Bolton Hospital
Bolton, , United Kingdom
University Hospitals Coventry & Warwick
Coventry, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Princess Royal
Glasgow, , United Kingdom
Southern General
Glasgow, , United Kingdom
Liverpool Women's Hospital
Liverpool, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Homerton University Hospital
London, , United Kingdom
Northwick Park Hospital
London, , United Kingdom
St Mary's Hospital
Manchester, , United Kingdom
Nottingham City/Queens Medical Centre
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Queen Alexandra
Portsmouth, , United Kingdom
Princess Anne
Southampton, , United Kingdom
Stoke Mandeville Hospital
Stoke Mandeville, , United Kingdom
University Hospital North Staffs
Stoke-on-Trent, , United Kingdom
Warrington Hospital
Warrington, , United Kingdom
Warwick Hospital
Warwick, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
2017 results
2018 results
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06/38/01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.