Condition category
Pregnancy and Childbirth
Date applied
25/09/2008
Date assigned
30/09/2008
Last edited
07/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Babies continue to die in labour or are born with brain injury due to a lack of oxygen during their birth. One way of trying to prevent babies suffering due to a lack of oxygen during birth is to monitor the baby's heart rate. This monitoring is not always easy to interpret. Some patterns are the baby's normal response to the stress of labour whilst others indicate a lack of oxygen. Expertise and experience are essential for accurate interpretation, and mistakes are common. This study will test whether an intelligent computer program can help midwives and doctors improve the care they give in response to abnormalities of the baby's heart rate, and whether this will lead to fewer babies being harmed because of a lack of oxygen.

Who can participate?
Pregnant women who require electronic foetal monitoring (EFM)

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives standard care, with the healthcare team looking at the readings from the monitor. In the other group the monitoring is looked at by the ‘intelligent’ computer system as well as the healthcare team. Information is collected during labour on a monitoring machine. We also record details of when the mother and baby are discharged from the hospital, and details of any treatments they receive whilst in hospital. Some of the participants are also contacted with questionnaires at 1 and 2 years after the birth to ask about their general health and how often they have used the NHS since giving birth.

What are the possible benefits and risks of participating?
We cannot promise that the study will help participants but the information we get from this study may help improve the care provided to women in labour in the future. All information we collect will be kept strictly confidential. Participant will still receive the same level of monitoring from the doctors and midwife whether you participate in the study or not.

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
September 2009 to May 2014

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof Peter Brocklehurst

Trial website

http://www.npeu.ox.ac.uk/infant

Contact information

Type

Scientific

Primary contact

Prof Peter Brocklehurst

ORCID ID

Contact details

National Perinatal Epidemiology Unit (NPEU)
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 06/38/01

Study information

Scientific title

A multicentre randomised controlled trial of an intelligent system to support decision making in the management of labour using the cardiotocogram (INFANT)

Acronym

INFANT (INtelligent Foetal AssessmeNT) Trial

Study hypothesis

The study will test whether use of decision-support software can help midwives and doctors improve the care they give in response to abnormalities of the baby's heart rate during labour and whether this will lead to fewer babies being harmed because of a lack of oxygen.

The objectives of the study are:
1. To determine whether intelligent decision-support can improve interpretation of the intrapartum cardiotocograph (CTG) and therefore improve the management of labour for women who are judged to require continuous electronic heart rate monitoring. Specifically, will the system, compared with current clinical practice:
1.1. Identify more clinically significant heart rate abnormalities?
1.2. Result in more prompt and timely action on clinically significant heart rate abnormalities?
1.3. Result in fewer "poor neonatal outcomes"?
1.4. Change the incidence of operative interventions?
2. To assess whether use of intelligent decision-support improves the quality of routine care received by women undergoing continuous electronic fetal monitoring during labour. This information will be important for evaluating whether the decision-support software decreases the risk of suboptimal care in labour; it will also be useful to explore the effect that such an intervention may have on litigation for obstetrics.
3. To determine whether the use of the decision-support software is cost-effective in terms of the incremental cost per poor perinatal outcome prevented.
4. To determine whether use of the decision-support software has any effect on the longer term neurodevelopment of children born to women participating in the INFANT study

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/063801
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0020/51383/PRO-06-38-01.pdf

Ethics approval

Northern & Yorkshire Research Ethics Committee (REC), Ref: 09/H0903/31

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.ucl.ac.uk/cctu/researchareas/womenshealth/infant/documents/Participant_Information_leaflet

Condition

Labour management

Intervention

The specific piece of decision-support software to be evaluated in INFANT has been designed by K2 Medical Systems 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.

The decision-support software being evaluated in INFANT extracts the important features of baseline heart rate, heart-rate variability, accelerations, type and timing of decelerations, the quality of the signal and the contraction pattern from the CTG. The decision-support software then analyses these data along with the quality of the signals. The system's assessment of the CTG is presented as a series of alerts or alarms depending on the severity of the abnormality detected. The clinician is able to review the system's logical reasoning by selecting a 'why' button. The system can therefore be viewed as an intelligent prompt, but by recording the chronology of events it also offers the opportunity to later audit the actual clinical decision-making process.

The Guardian™ system on each labour ward will include random-number-generation software which will assign participating women to 'no decision-support' or 'decision-support'. Clinicians will not be masked to allocation. The aim is to randomise 46,000 women to the trial over 36 months.

A random sample of 7,000 surviving children (3,500 in each group) will be followed up at two years of age. This sample will be taken from within the sample recruited during the first two years of the project so that follow-up of this group can be completed around the time that the trial stops recruiting.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Short term: 'Poor neonatal outcome' to include:
1.1. All perinatal deaths, except deaths due to congenital anomalies
1.2. Significant morbidity: neonatal encephalopathy; other admissions to neonatal intensive care unit (NICU) within 48 hours of birth for 48 hours or more, which are associated with adverse intrapartum events including respiratory symptoms and seizures
2. Long term: Developmental Quotient (DQ) at the age of two years

Secondary outcome measures

1. Cord-artery pH <7.05 with base deficit of 12 mmol/l or more
2. Apgar score <4 at 5 minutes
3. Caesarean section
4. Any operative intervention for (i) foetal distress and (ii) failure to progress
5. Foetal blood sampling
6. Length of labour
7. Episiotomy rates
8. Proportion of babies with an adverse outcome (trial primary outcome plus cord-artery pH <7.05 with base deficit 12 mmol/l or more) judged to have experienced suboptimal care in labour

Overall trial start date

01/09/2009

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Women admitted to a participating labour ward who fulfil all of the following criteria will be eligible to be randomised in the trial (no age limits):
1. They are judged to require continuous electronic foetal monitoring (EFM) by the local clinical team based on their existing guidelines, and the woman consents to have EFM, and EFM is possible
2. They have a singleton or twin pregnancy
3. They are above or equal to 35 weeks' gestation
4. There is no known gross foetal abnormality
5. They are able to give consent to participate in the trial as judged by the attending clinicians

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

46,000 births

Participant exclusion criteria

1. Triplets or higher order pregnancy
2. Criteria for EFM not met

Recruitment start date

01/09/2009

Recruitment end date

31/05/2014

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

http://www.admin.ox.ac.uk/rso

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/01/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26791569

Publication citations

Additional files

Editorial Notes

07/10/2016: Publication reference added. 20/04/2016: Plain English summary added. 05/10/2009: The overall trial start and end dates were updated from 01/06/2009 and 28/02/2014 to 01/09/2009 and 31/05/2014, respectively. 21/08/2009: The overall trial start and end dates were updated from 01/10/2009 and 30/09/2013 to 01/06/2009 and 28/02/2014, respectively.