INFANT Trial Findings

A recent, large scale study has released findings in regards to the effect of computerised assessment system of continuous electronic fetal monitoring during labour.

The study compared women who received continuous electronic fetal monitoring (EFM) during labour, with those who received this monitoring as well as computerised assessment of the monitoring, through software produced by INFANT K2 Medical Systems. The aim was to discover whether the additional computerised assessment improved various outcomes such as injury or stillbirth during labour.

Whilst the risk of serious injury or stillbirth during labour is rare in the UK, lack of oxygen (fetal hypoxia) leads to approximately 2 in every 1,000 babies developing brain damage, and 1 in every 1,000 babies dying during or soon after birth. This trial was set up to see whether the computerised assessment, alongside assessment of a healthcare professional, could reduce stillbirth or injury.

The trial was run across 21 sites in the UK and Ireland, in women over 35 weeks pregnant, who were already being offered continuous EFM for labour. Between January 2010 and August 2013, 47,062 mothers in labour were randomised into the trial. A large sample size was needed due to the rarity of the outcomes being compared. Two main outcomes were assessed: neonatal outcome for the entire sample, and development progress in a subset of children up until the age of 2.

Overall the team concluded that: “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.”

And in more detail, the results showed that:

“Using the continuous EFM plus K2 INFANT computer-generated decision-support system did not make any difference to outcomes for babies at birth or at two years compared to continuous EFM alone. At birth, 0.7% of babies had a poor outcome (172 in the continuous EFM plus INFANT decision-support group compared with 171 in the continuous EFM only group).

Just over half of all births were vaginal births without forceps and there was no statistically significant difference between the two groups in this outcome (50.8% of women in the continuous EFM plus INFANT decision-support group versus 51.2% in the continuous EFM only group). There were no differences in rates of forceps births or emergency caesarean births.

More women in the continuous EFM plus INFANT decision-support group had a blood sample taken from their unborn baby’s scalp (10.3% vs 9.5% in the continuous EFM only group). No other statistically significant differences were found between the two groups.”

Read more about the study here.