Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn InfantINFANTNCT02010710
Use of Decision Support in the Management of Labour
A study testing INFANT software in people with Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant and Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is, run by University College, London at 21 sites in 2 countries.
Trial summary
In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant, Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is, Possible
- What is being tested?
- INFANT software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47,062 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 6 Jan 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Require continuous electronical fetal monitoring during labour
- they have a singleton or twin pregnancy
- they are ≥ 35 weeks' gestation (≥ 245 days)
- there is no known gross fetal abnormality, including any known fetal heart arrhythmia such as heart block
- they are 16 years of age or older
- they are able to give consent to participate in the trial as judged by the attending clinicians.
Who cannot join
- • triplets or higher order pregnancy
- criteria for EFM not met, including elective caesarean section prior to the onset of labour
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United Kingdom20 sites
Birmingham Women's Hospital
Birmingham
Royal Bolton Hospital
Bolton
Lancashire Women's and Newborn Centre
Burnley, Lancs, BB12 2 PQ
University Hospitals Coventry & Warwick
Coventry
Royal Derby Hospital
Derby
Princess Royal
Glasgow
Southern General
Glasgow
Liverpool Women's Hospital
Liverpool
Chelsea and Westminster Hospital
London
Homerton University Hospital
London
Northwick Park Hospital
London
St Mary's Hospital
Manchester
Nottingham City/Queens Medical Centre
Nottingham
Derriford Hospital
Plymouth
Queen Alexandra
Portsmouth
Princess Anne
Southampton
Stoke Mandeville Hospital
Stoke Mandeville
University Hospital North Staffs
Stoke-on-Trent
Warrington Hospital
Warrington
Warwick Hospital
Warwick
About this study
Official title: A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram
In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: "No decision-support" - CTGs with no additional interpretation (UK standard care), compared with: "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. How the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the Guardian™ system.
- Conditions
- Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant, Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is, Possible
- Being tested
- INFANT software
- Keywords
- continuous electronic fetal monitoring, labour, pregnancy, fetal distress
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFANT softwareDevice
The decision-support software to be evaluated in INFANT has been designed 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. As such, it replaces conventional paper labour notes, the CTG machine and other recording systems for documenting care during labour.
| Study group | Role | What they receive |
|---|---|---|
| Decison support | Experimental | "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. Receives: Device: INFANT software |
| No Decision Support | No intervention | "No decision-support" - CTGs with no additional interpretation (UK standard care), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admissions to higher level of care
A composite of 'poor perinatal outcome' to include (a) all deaths (intrapartum stillbirths plus neonatal deaths i.e. deaths up to 28 days after birth) except deaths due to congenital anomalies, (b) significant morbidity: neonatal encephalopathy (moderate and severe); (c) admissions to the neonatal unit within 48 hours of birth for ≥ 48 hrs with evidence of feeding difficulties, respiratory illness or encephalopathy.
Measured: within 48 hours and for longer than 48 hours
Secondary outcomes (1)
Neuro Development
PARCA-R composite score at the age of two years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study start6 Jan 2010
- Primary completionAug 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn InfantStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47,062 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Birmingham, University of Plymouth, University of Leicester, National Childbirth Trust, K2 Medical Systems
- Responsible party
- Sponsor
- Investigators
- Peter Brocklehurst, Professor, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010710
- Sponsor's protocol ID
- 06/38/01
- Acronym
- INFANT
- Status last verified
- Oct 2018
- First submitted
- 27 Jun 2013
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram
- ClinicalTrials.gov ID
- NCT02010710
- Acronym / sponsor ID
- INFANT / 06/38/01
- Conditions
- Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant, Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is, Possible
- Keywords
- continuous electronic fetal monitoring, labour, pregnancy, fetal distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,062 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Oxford, University of Birmingham, University of Plymouth, University of Leicester, National Childbirth Trust, K2 Medical Systems
- Study start
- 6 Jan 2010 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: "No decision-support" - CTGs with no additional interpretation (UK standard care), compared with: "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. How the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the Guardian™ system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decison support | Experimental | Device: INFANT software"Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. |
| No Decision Support | No intervention | –"No decision-support" - CTGs with no additional interpretation (UK standard care), |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Require continuous electronical fetal monitoring during labour
Key exclusion criteria (2 listed)
- • triplets or higher order pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INFANT softwareThe decision-support software to be evaluated in INFANT has been designed 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. As such, it replaces conventional paper labour notes, the CTG machine and other recording systems for documenting care during labour. | Device | Decison support |
Primary outcome
Admissions to higher level of care
Time frame: within 48 hours and for longer than 48 hours
A composite of 'poor perinatal outcome' to include (a) all deaths (intrapartum stillbirths plus neonatal deaths i.e. deaths up to 28 days after birth) except deaths due to congenital anomalies, (b) significant morbidity: neonatal encephalopathy (moderate and severe); (c) admissions to the neonatal unit within 48 hours of birth for ≥ 48 hrs with evidence of feeding difficulties, respiratory illness or encephalopathy.
1 secondary outcome
Neuro Development
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- 2017 resultsLink provided by the sponsor.
- 2018 resultsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Brocklehurst, Professor principal investigator
University of Birmingham
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INFANT software in people with Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant and Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is, run by University College, London at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admissions to higher level of care (time frame: within 48 hours and for longer than 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.