Contact information
Type
Scientific
Primary contact
Prof Christine MacArthur
ORCID ID
Contact details
Department of Public Health and Epidemiology
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4146770
c.macarthur@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCH 02-19
Study information
Scientific title
A randomised controlled trial of two types of epidural analgesia evaluating short and long term outcomes, including backache
Acronym
COMET
Study hypothesis
Using 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
Approval received from Birmingham and Leicester research ethics committees (added 21/12/09)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Childbirth
Intervention
1. Standard epidural
2. Mobile combined spinal-epidural
3. Mobile 'Boston' epidural.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1997
Overall trial end date
01/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Women 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1050 (added 21/12/09
Participant exclusion criteria
Women 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.
Recruitment start date
01/07/1997
Recruitment end date
01/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Public Health and Epidemiology
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Mother and Child Health National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11454372
2. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12459686
3. 2009 results on urinary catheterisation with anaesthesia in http://www.ncbi.nlm.nih.gov/pubmed/18987057
4. 2009 results on ambulation in labour and delivery mode with anaesthesia in http://www.ncbi.nlm.nih.gov/pubmed/19302638
5. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19945274
Publication citations
-
Results
Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial., Lancet, 2001, 358, 9275, 19-23, doi: 10.1016/S0140-6736(00)05251-X.
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Results on urinary catheterisation with anaesthesia
Wilson MJ, Macarthur C, Shennan A, , Urinary catheterization in labour with high-dose vs mobile epidural analgesia: a randomized controlled trial., Br J Anaesth, 2009, 102, 1, 97-103, doi: 10.1093/bja/aen313.
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Results
Cooper GM, MacArthur C, Wilson MJ, Moore PA, Shennan A, , Satisfaction, control and pain relief: short- and long-term assessments in a randomised controlled trial of low-dose and traditional epidurals and a non-epidural comparison group., Int J Obstet Anesth, 2010, 19, 1, 31-37, doi: 10.1016/j.ijoa.2009.05.004.
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Wilson MJ, Cooper G, MacArthur C, Shennan A, , Randomized controlled trial comparing traditional with two "mobile" epidural techniques: anesthetic and analgesic efficacy., Anesthesiology, 2002, 97, 6, 1567-1575.
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Wilson MJ, MacArthur C, Cooper GM, Shennan A, , Ambulation in labour and delivery mode: a randomised controlled trial of high-dose vs mobile epidural analgesia., Anaesthesia, 2009, 64, 3, 266-272, doi: 10.1111/j.1365-2044.2008.05756.x.