Epidural related maternal temperature and neonatal outcome: a randomised controlled study
| ISRCTN | ISRCTN33477809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33477809 |
| Secondary identifying numbers | N0060148249 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 21/04/2011
- 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 of protocol
Not provided at time of registration
Contact information
Prof Philip Steer
Scientific
Scientific
Dept of Obstetrics & Gynaecology
Chelsea & Westminster Hospial
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)20 8846 7892 |
|---|---|
| p.steer@imperial.ac.uk |
Study information
| Study design | Single blind interventional randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | |
| Study objectives | Maintaining normothermia during labour (including prevention of hyperthermia) will improve outcome in relation to: 1. Short term outcome: 1.1. Obstetric interventions - FBS, emergency caesarean section, instrumental delivery 1.2. Neonatal outcome - neonatal tone and neurobehaviour, neonatal encephalopathy, neonatal sepsis work up and antibiotic treatment, free oxygen radical induced cellular injury 2. Long term outcome - score on Griffiths mental developmental scales at 1 year Please note that as of 27/06/2008, this record was updated to reflect that this trial was proposed but never started. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Labour |
| Intervention | Maintaining normothermia during labour versus care as usual. |
| Intervention type | Other |
| Primary outcome measure | Differences in mean NACS score at 24 +/- 6 hours between the intervention and control group |
| Secondary outcome measures | 1. Differences in emergency caesarean and instrumental deliveries 2. Foetal intervention - FBS 3. Neonatal adverse outcomes - resuscitation requirements, Apgar score at 1 and 5 minutes, cord gases, feeding difficulties, encephalopathy 4. Neonatal intervention rate with sepsis evaluation and antibiotic treatment 5. Measurement of free oxygen radical metabolites (e.g. malonildehyde) as marker of lipid peroxidation in cord blood |
| Overall study start date | 01/01/2003 |
| Completion date | 01/11/2004 |
| Reason abandoned (if study stopped) | This trial was proposed but never started as the research fellow was appointed to a substantive post and left the project. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 800 |
| Key inclusion criteria | 400 women in each group |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/11/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Obstetrics & Gynaecology
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Chelsea and Westminster Healthcare NHS Trust (UK)
No information available
NHS R&D Support Funding (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 |
