Randomised controlled trial of the clinical impact of an intelligent decision making support tool for labour management using the cardiotocogram

ISRCTN	ISRCTN48614382
DOI	https://doi.org/10.1186/ISRCTN48614382
Secondary identifying numbers	G9721800

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Keith Greene
Scientific

Perinatal Research Group
Postgraduate Medical School
University of Plymouth
Maternity Unit
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Phone	+44 1752 763631
Email	k.greene@plymouth.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Randomised controlled trial of the clinical impact of an intelligent decision making support tool for labour management using the cardiotocogram
Study objectives	To determine whether an intelligent support system can improve outcomes for mother and baby for current foetal monitoring by reducing human error.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/1999
Completion date	31/05/2004

Participant type(s)	Patient
Age group	Adult
Sex	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.
Key inclusion criteria	All consented pregnancies after 34 weeks gestation with no gross foetal anomaly undergoing electronic foetal monitoring (EFM) in labour
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/1999
Date of final enrolment	31/05/2004

Perinatal Research Group

Plymouth
PL6 8DH
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

28/02/2018: No publications found, verifying study status with principal investigator.