University of Leicester
Browse
1/1
2 files

Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial

journal contribution
posted on 2018-01-03, 14:50 authored by Peter Brocklehurst, David Field, Keith Greene, Ed Juszczak, Robert Keith, Sara Kenyon, Louise Linsell, Christopher Mabey, Mary Newburn, Rachel Plachcinski, Maria Quigley, Elizabeth Schroeder, Philip Steer, The INFANT Collaborative Group
Background Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes. Methods In this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152. Findings Between Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups—172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82–1·25). At 2 years, no significant differences were noted in terms of developmental assessment. Interpretation Use of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies.

Funding

This study was funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment programme (project number 06.38.01). SK was partly funded by the NIHR Collaboration for Leadership in Applied Health Research and Care West Midlands. The quality-of-care review panel consisted of an obstetrician (PS), neonatologist (Ilya Kovar), and midwife (Christina McKenzie) for all sessions except one, when CM was replaced by Mary Griffin. Previous funding from the UK Medical Research Council enabled the initial development of Guardian and the INFANT software.

History

Citation

Lancet, 2017, 389 (10080), pp. 1719-1729 (11)

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Health Sciences

Version

  • VoR (Version of Record)

Published in

Lancet

Publisher

Elsevier

issn

0140-6736

eissn

1474-547X

Copyright date

2017

Available date

2018-01-03

Publisher version

http://www.sciencedirect.com/science/article/pii/S0140673617305688?via=ihub

Notes

See Online for appendix

Language

en

Usage metrics

    University of Leicester Publications

    Categories

    No categories selected

    Licence

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC