Randomised, double-blind, controlled study of combined spinal epidural (CSE) analgesia for labour with and without epidural volume extension (EVE).
| ISRCTN | ISRCTN21230935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21230935 |
| Secondary identifying numbers | N0016127111 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 31/07/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Gary Stocks
Scientific
Scientific
Department of Anaesthesia
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
| Study design | Randomised double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | |
| Study hypothesis | Whether using the CSE technique with EVE, can achieve the same quality of analgesia but with a quicker onset of action, and reduce the degree of unwanted motor block currently experienced in a proportion of patients. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Pregnancy and Childbirth: Analgesia |
| Intervention | As of 29/07/09 the status of this trial was changed to 'stopped'. This trial was never commenced. Not provided at time of registration. |
| Intervention type | Other |
| Primary outcome measure | To improve our existing CSE labour analgesia, in terms of rapidity of onset of action and decreased motor block in the lower limbs allowing earlier ambulation. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2003 |
| Overall study end date | 31/07/2004 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 0 |
| Participant inclusion criteria | Not provided at time of registration |
| Participant exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 01/07/2003 |
| Recruitment end date | 31/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Hammersmith Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
