Overview

This trial is active, not recruiting.

Conditions fetal intrauterine distress first noted during labor and/or delivery in liveborn infant, team based on their existing guidelines, and the woman consents to have efm, and efm is, possible.
Treatment infant software
Sponsor University College, London
Collaborator University of Oxford
Start date January 2010
End date August 2013
Trial size 46000 participants
Trial identifier NCT02010710, 06/38/01

Summary

In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: "No decision-support" - CTGs with no additional interpretation (UK standard care), compared with: "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. How the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the Guardian™ system.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
"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 Intervention)
"No decision-support" - CTGs with no additional interpretation (UK standard care),

Primary Outcomes

Measure
Admissions to higher level of care
time frame: within 48 hours and for longer than 48 hours

Secondary Outcomes

Measure
Neuro Development
time frame: 2 years

Eligibility Criteria

Female participants at least 16 years old.

Inclusion Criteria: - Require continuous electronical fetal monitoring during labour - 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: - • triplets or higher order pregnancy - criteria for EFM not met, including elective caesarean section prior to the onset of labour

Additional Information

Official title A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram
Principal investigator Peter Brocklehurst, Professor
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University College, London.