COMET: Comparative Mobile Epidural Trial

ISRCTN	ISRCTN49349244
DOI	https://doi.org/10.1186/ISRCTN49349244
Protocol serial number	MCH 02-19
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Mother and Child Health National Research and Development Programme (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2001

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1050
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

Department of Public Health and Epidemiology

Birmingham
B15 2TT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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