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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT02010710
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)
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(s)
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
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
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
Primary outcome measure
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 study start date
01/09/2009
Overall study end date
31/05/2014
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, Ireland, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/01/2017
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/01/2016 | Yes | No | |
| Results article | results | 29/04/2017 | Yes | No | |
| Results article | results | 01/02/2018 | Yes | No | |
| Other publications | economic evaluation | 01/03/2021 | 18/08/2020 | Yes | No |