Clinical trial NCT02010710: Use of Decision Support in the Management of Labour
Official title: A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: University of Birmingham
name: University of Plymouth
name: University of Leicester
name: National Childbirth Trust
name: K2 Medical Systems
First posted: 2013-12-13
Enrollment: 47062
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* • triplets or higher order pregnancy

  * criteria for EFM not met, including elective caesarean section prior to the onset of labour

Primary outcomes:
measure: Admissions to higher level of care
timeFrame: within 48 hours and for longer than 48 hours
Secondary outcomes:
measure: Neuro Development
timeFrame: 2 years
Other outcomes:
measure: Infant outcomes
timeFrame: during admission and at 2 years
measure: Mother
timeFrame: during admission
Locations:
city: Dublin
country: Ireland
facility: Rotunda
city: Burnley
country: United Kingdom
facility: Lancashire Women's and Newborn Centre
state: Lancs
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwick
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Glasgow
country: United Kingdom
facility: Princess Royal
city: Glasgow
country: United Kingdom
facility: Southern General
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Homerton University Hospital
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: Manchester
country: United Kingdom
facility: St Mary's Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City/Queens Medical Centre
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra
city: Southampton
country: United Kingdom
facility: Princess Anne
city: Stoke Mandeville
country: United Kingdom
facility: Stoke Mandeville Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital North Staffs
city: Warrington
country: United Kingdom
facility: Warrington Hospital
city: Warwick
country: United Kingdom
facility: Warwick Hospital
Study officials:
affiliation: University of Birmingham
name: Peter Brocklehurst, Professor
role: PRINCIPAL_INVESTIGATOR
References: