COMET: Comparative Mobile Epidural Trial
ISRCTN | ISRCTN49349244 |
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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
Scientific
Department of Public Health and Epidemiology
Medical School
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Phone | +44 (0)121 4146770 |
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c.macarthur@bham.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A randomised controlled trial of two types of epidural analgesia evaluating short and long term outcomes, including backache |
Study acronym | COMET |
Study objectives | 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(s) | Approval received from Birmingham and Leicester research ethics committees (added 21/12/09) |
Health condition(s) or problem(s) studied | Childbirth |
Intervention | 1. Standard epidural 2. Mobile combined spinal-epidural 3. Mobile 'Boston' epidural. |
Intervention type | Other |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/07/1997 |
Completion date | 01/10/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 1050 (added 21/12/09 |
Key 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. |
Key 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. |
Date of first enrolment | 01/07/1997 |
Date of final enrolment | 01/10/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Public Health and Epidemiology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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 |