ISRCTN ISRCTN49349244
DOI https://doi.org/10.1186/ISRCTN49349244
Secondary identifying numbers MCH 02-19
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
21/12/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Christine MacArthur
Scientific

Department of Public Health and Epidemiology
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone +44 (0)121 4146770
Email c.macarthur@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised controlled trial of two types of epidural analgesia evaluating short and long term outcomes, including backache
Study acronymCOMET
Study objectivesUsing a randomised controlled design we propose to investigate
1. Whether an epidural technique which provides minimal motor block is associated with differences in the more traditional technique and
2. Whether there are any variations in these respects between two different types of minimal motor block epidural techniques

Please note that as of 21/12/09, this record was updated to include information on ethics approval, target number of participants and publications.
Ethics approval(s)Approval received from Birmingham and Leicester research ethics committees (added 21/12/09)
Health condition(s) or problem(s) studiedChildbirth
Intervention1. Standard epidural
2. Mobile combined spinal-epidural
3. Mobile 'Boston' epidural.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/1997
Completion date01/10/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants1050 (added 21/12/09
Key inclusion criteriaWomen who have decided to have an epidural. Patient consent to take part in the trial can only be fully given at the time of deciding to have an epidural, but to avoid 'cold' decision making in labour an explanatory leaflet will be provided for all primiparae at the last routine hospital antenatal visit (approximately 34 weeks). Only primigravida will be recruited in order to make a meaningful comparison of obstetric performance, given the profound effect of parity on the main outcome measure, and to avoid 'contamination' of experience and recall of backache after previous deliveries.
Key exclusion criteriaWomen who require regional block anaesthesia for an elective section or for imminent operative delivery will be excluded. Additionally, those who have contra-indications to spinal or epidural analgesia (e.g. coagulopathy, cardiomyopathy, valvular cardiac disease, abnormal vertebral anatomy, etc) or to any drug in the study will also be excluded.
Date of first enrolment01/07/1997
Date of final enrolment01/10/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Public Health and Epidemiology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Mother and Child Health National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 07/07/2001 Yes No
Results article results 01/12/2002 Yes No
Results article results on urinary catheterisation with anaesthesia 01/01/2009 Yes No
Results article results on ambulation in labour and delivery mode with anaesthesia 01/03/2009 Yes No
Results article results 01/01/2010 Yes No