| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN33931714 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0060187568 |
| Public title | Peri-operative fluid warming in elective caesarean section |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Pregnancy and Childbirth: Caesarean section |
| Study hypothesis | Does providing warmed intravenous fluid at elective caesarean section reduce the incidence of hypothermia and improve maternal thermal comfort? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Healthy women with uncomplicated single pregnancy of > 37 weeks¿ gestation due for elective caesarean section |
| Participants - 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). |
| Patient information material |
|
| Anticipated start date | 25/10/2006 |
| Anticipated end date | 01/12/2007 |
| Status of trial | Completed |
| Target number of participants | 75 to be recruited consecutively |
| Interventions | Warmed intravenous fluid vs no warmed intravenous fluid |
| Primary outcome measure(s) | 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 measure(s) | 1. Shivering
2. Self-reported thermal comfort |
| Sources of funding | Chelsea and Westminster Healthcare NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Steve Yentis |
| Contact details | Magill Dept of Anaesthesia, Intensive Care & Pain Management
Chelsea and Westminster Hospital
369 Fulham Road
London
United Kingdom
SW10 9NH |
| Contact telephone | +44 020 8746 8026 |
| Contact fax | +44 020 8746 8801 |
| Contact email | s.yentis@imperial.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN33931714 |
| Date last extracted from ISRCTN register | 17/04/2008 |
