Peri-operative fluid warming in elective caesarean section
| ISRCTN | ISRCTN33931714 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33931714 |
| Secondary identifying numbers | N0060187568 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Steve Yentis
Scientific
Scientific
Magill Dept of Anaesthesia, Intensive Care & Pain Management
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)20 8746 8026 |
|---|---|
| s.yentis@imperial.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Does providing warmed intravenous fluid at elective caesarean section reduce the incidence of hypothermia and improve maternal thermal comfort? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Caesarean section |
| Intervention | Warmed intravenous fluid vs no warmed intravenous fluid |
| Intervention type | Other |
| Primary outcome measure | Core body temperature, incidence and severity of shivering and pain (Visual Analogue Scale), thermal comfort score (visual analogue scale), fetal Apgar scores and umbilical cord blood gas measurements (routinely performed at caesarean section) |
| Secondary outcome measures | 1. Shivering 2. Self-reported thermal comfort |
| Overall study start date | 25/10/2006 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 75 to be recruited consecutively |
| Key inclusion criteria | Healthy women with uncomplicated single pregnancy of > 37 weeks gestation due for elective caesarean section |
| Key exclusion criteria | 1. Pyrexia 2. Inability to take non-steroidal anti-inflammatory (NSAIDs) medication 3. Pre-eclampsia/eclampsia 4. Drug therapy other than antacids and vitamins/minerals 5. Increased risk of intra-operative haemorrhage (eg placenta praevia or accreta). |
| Date of first enrolment | 25/10/2006 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Magill Dept of Anaesthesia, Intensive Care & Pain Management
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, 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
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | Yes | No |
