COMET: Comparative Mobile Epidural Trial
- Conditions
- ChildbirthPregnancy and Childbirth
- Registration Number
- ISRCTN49349244
- Lead Sponsor
- Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1050
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration