Trial record 11 of 1377 for:    (infant OR newborn) AND (woman OR women OR female) NOT (male OR men)

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Oxford
University of Birmingham
University of Plymouth
University of Leicester
National Childbirth Trust
K2 Medical Systems
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT02010710
First received: June 27, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by University College, London:

Primary Outcome Measures:
  • Admissions to higher level of care [ Time Frame: within 48 hours and for longer than 48 hours ] [ Designated as safety issue: Yes ]
    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:
  • Neuro Development [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    PARCA-R composite score at the age of two years


Other Outcome Measures:
  • Infant outcomes [ Time Frame: during admission and at 2 years ] [ Designated as safety issue: Yes ]
    • 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

  • Mother [ Time Frame: during admission ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 46000
Study Start Date: January 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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),

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010710

Locations
Ireland
Rotunda
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
Homerton University Hospital
London, United Kingdom
Chelsea and Westminster 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
Investigators
Principal Investigator: Peter Brocklehurst, Professor University College, London
  More Information

Additional Information:
No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02010710     History of Changes
Other Study ID Numbers: 06/38/01
Study First Received: June 27, 2013
Last Updated: December 13, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 20, 2014