Use of Decision Support in the Management of Labour (INFANT)

A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram

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.

Study Overview

• Status: Completed
• 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
• Intervention / Treatment: Device: INFANT software

• Study Type: Interventional
• Enrollment (Actual): 47062
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Rotunda
• United Kingdom
  • Birmingham, United Kingdom
    • Birmingham Women's Hospital
  • Bolton, United Kingdom
    • Royal Bolton Hospital
  • Coventry, United Kingdom
    • University Hospitals Coventry & Warwick
  • Derby, United Kingdom
    • Royal Derby Hospital
  • Glasgow, United Kingdom
    • Princess Royal
  • Glasgow, United Kingdom
    • Southern General
  • Liverpool, United Kingdom
    • Liverpool Women's Hospital
  • London, United Kingdom
    • Northwick Park Hospital
  • London, United Kingdom
    • Chelsea and Westminster Hospital
  • London, United Kingdom
    • Homerton University Hospital
  • Manchester, United Kingdom
    • St Mary's Hospital
  • Nottingham, United Kingdom
    • Nottingham City/Queens Medical Centre
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Portsmouth, United Kingdom
    • Queen Alexandra
  • Southampton, United Kingdom
    • Princess Anne
  • Stoke Mandeville, United Kingdom
    • Stoke Mandeville Hospital
  • Stoke-on-Trent, United Kingdom
    • University Hospital North Staffs
  • Warrington, United Kingdom
    • Warrington Hospital
  • Warwick, United Kingdom
    • Warwick Hospital
  • Lancs
    • Burnley, Lancs, United Kingdom, BB12 2 PQ
      • Lancashire Women's and Newborn Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: No Decision Support; "No decision-support" - CTGs with no additional interpretation (UK standard care),

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admissions to higher level of care	A composite of 'poor perinatal outcome' to include (a) all deaths (intrapartum stillbirths plus neonatal deaths i.e. deaths up to 28 days after birth) except deaths due to congenital anomalies, (b) significant morbidity: neonatal encephalopathy (moderate and severe); (c) admissions to the neonatal unit within 48 hours of birth for ≥ 48 hrs with evidence of feeding difficulties, respiratory illness or encephalopathy.	within 48 hours and for longer than 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuro Development	PARCA-R composite score at the age of two years	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant outcomes	Metabolic acidosis defined as a cord-artery pH <7.05 (this is 2 standard deviations below the mean) with base deficit ≥ 12 mmol/l (this is a threshold above which the risks of neurological damage increase); The distribution of cord-blood gas data for cord-artery pH; Apgar score <4 at 5 minutes; Intrapartum stillbirth; Neonatal death; Seizures; Resuscitation interventions; Admissions to neonatal unit within 48 hours of birth for at least 48 hours; Admissions to neonatal unit within 48 hours of birth for at least 48 hours with evidence of:EncephalopathyFeeding difficultiesRespiratory illness; Admission to a higher level of care; In the sub-set of 7,000 surviving children without any degree of encephalopathy and agreed to be followed-up at age 2 years:PARCA-R composite scoreCerebral palsy - (determined by asking the parents if their child has Cerebral palsy)Late deaths (after the neonatal period)General health issues at 2 years	during admission and at 2 years
Mother	Mode of delivery; Any operative intervention (caesarean section and instrumental delivery) for i. fetal distress, or ii. failure to progress, or iii. combination of fetal distress and failure to progress iv. other reason; Any episode of fetal blood sampling; Episiotomy; Grade of caesarean section; Length of first stage, length of second stage, total length of labour from trial entry	during admission

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University of Oxford; University of Plymouth; University of Birmingham; University of Leicester; National Childbirth Trust; K2 Medical Systems
• Investigators: Principal Investigator: Peter Brocklehurst, Professor, University of Birmingham

Publications and helpful links

Helpful Links

• 2017 results
• 2018 results

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2010
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (ESTIMATE): December 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pregnancy; labour; fetal distress; continuous electronic fetal monitoring
• Other Study ID Numbers: 06/38/01