Condition category
Pregnancy and Childbirth
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
19/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes