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

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ClinicalTrials.gov Identifier: NCT02010710
Recruitment Status : Unknown
Verified December 2013 by University College, London.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2013
Last Update Posted : December 16, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
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. Device: INFANT software

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram
Study Start Date : January 2010
Primary Completion Date : August 2013
Estimated Study Completion Date : May 2014
Arms and Interventions

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),

Outcome Measures

Primary Outcome Measures :
  1. Admissions to higher level of care [ Time Frame: within 48 hours and for longer than 48 hours ]
    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.

Secondary Outcome Measures :
  1. Neuro Development [ Time Frame: 2 years ]
    PARCA-R composite score at the age of two years

Other Outcome Measures:
  1. Infant outcomes [ Time Frame: during admission and at 2 years ]
    • 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:

      • Encephalopathy
      • Feeding difficulties
      • Respiratory 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 score
      • Cerebral palsy - (determined by asking the parents if their child has Cerebral palsy)
      • Late deaths (after the neonatal period)
      • General health issues at 2 years

  2. Mother [ Time Frame: during admission ]
    • 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

Eligibility Criteria

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010710

Dublin, Ireland
United Kingdom
Lancashire Women's and Newborn Centre
Burnley, Lancs, United Kingdom, BB12 2 PQ
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
Sponsors and Collaborators
University College, London
University of Oxford
University of Birmingham
University of Plymouth
University of Leicester
National Childbirth Trust
K2 Medical Systems
Principal Investigator: Peter Brocklehurst, Professor University College, London
More Information

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02010710     History of Changes
Other Study ID Numbers: 06/38/01
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013

Keywords provided by University College, London:
continuous electronic fetal monitoring
fetal distress