Use of Decision Support in the Management of Labour

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.

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

Interventions

DEVICE

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.

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• University of Birmingham

  collaborator OTHER

• University of Plymouth

  collaborator OTHER

• University of Leicester

  collaborator OTHER

• National Childbirth Trust

  collaborator UNKNOWN

• K2 Medical Systems

  collaborator UNKNOWN

• University College, London

  lead OTHER

Principal Investigators

• Peter Brocklehurst, Professor · University of Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-06

Primary Completion

2013-08-31

Completion

2014-05-31

Countries

• Ireland
• United Kingdom

Study Locations