The Library
Computerised interpretation of fetal heart rate during labour (INFANT) : a randomised controlled trial
Tools
Tools
Tools
Brocklehurst, Peter, Field, David, Greene, Keith, Juszczak, Ed, Keith, Robert, Kenyon, Sara, Linsell, Louise, Mabey, Christopher, Newburn, Mary, Plachcinski, Rachel, Quigley, Maria, Schroeder, Elizabeth and Steer, Philip (2017) Computerised interpretation of fetal heart rate during labour (INFANT) : a randomised controlled trial. The Lancet, 389 (10080). pp. 1719-1729. doi:10.1016/s0140-6736(17)30568-8 ISSN 0140-6736.
|
PDF
PIIS0140-6736(17)30568-8.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (407Kb) | Preview |
Official URL: http://dx.doi.org/10.1016/s0140-6736(17)30568-8
Abstract
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.
| Item Type: | Journal Article | ||||||
|---|---|---|---|---|---|---|---|
| Subjects: | R Medicine > R Medicine (General) | ||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit | ||||||
| Journal or Publication Title: | The Lancet | ||||||
| Publisher: | Lancet Publishing Group | ||||||
| ISSN: | 0140-6736 | ||||||
| Official Date: | 21 March 2017 | ||||||
| Dates: |
|
||||||
| Volume: | 389 | ||||||
| Number: | 10080 | ||||||
| Page Range: | pp. 1719-1729 | ||||||
| DOI: | 10.1016/s0140-6736(17)30568-8 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 23 July 2018 | ||||||
| Date of first compliant Open Access: | 9 August 2018 | ||||||
| Funder: | National Institute for Health Research Health Technology Assessment (Great Britain) (NIHR HTA) | ||||||
| Grant number: | 60.38.01 | ||||||
| Contributors: |
|
Request changes or add full text files to a record
Repository staff actions (login required)
 |
View Item |
Downloads
Downloads per month over past year
