Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/12/2009
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 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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes