Contact information
Type
Scientific
Primary contact
Prof Keith Greene
ORCID ID
Contact details
Perinatal Research Group
Postgraduate Medical School
University of Plymouth
Maternity Unit
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
+44 1752 763631
k.greene@plymouth.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9721800
Study information
Scientific title
Randomised controlled trial of the clinical impact of an intelligent decision making support tool for labour management using the cardiotocogram
Acronym
Study hypothesis
To determine whether an intelligent support system can improve outcomes for mother and baby for current foetal monitoring by reducing human error.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Obstetrics and gynaecology
Intervention
EFM with and without decision support
Delivery - operative (Caesarean section or forceps) or spontaneous
Added 19/08/09:
Follow-up: One month in first instance. Longer term follow-up will almost certainly occur as part of a paediatric developmental study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Operative delivery rates for mother. Cord blood gas analysis, admissions to NICU, neonatal encephalopathy and perinatal mortality rates for baby.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/1999
Overall trial end date
31/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
All consented pregnancies after 34 weeks gestation with no gross foetal anomaly undergoing electronic foetal monitoring (EFM) in labour
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Corrected 19/08/09: data collection on all deliveries (30,000 - 35,000) occurring in the 6 units during the study of the 15,000 monitored in the RCT.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/1999
Recruitment end date
31/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Perinatal Research Group
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary