Contact information
Type
Scientific
Primary contact
Prof Philip Steer
ORCID ID
Contact details
Dept of Obstetrics & Gynaecology
Chelsea & Westminster Hospial
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 (0)20 8846 7892
p.steer@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0060148249
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Single blind interventional randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Pregnancy and Childbirth: Labour
Intervention
Maintaining normothermia during labour versus care as usual.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2003
Overall trial end date
01/11/2004
Reason abandoned
This trial was proposed but never started as the research fellow was appointed to a substantive post and left the project.
Eligibility
Participant inclusion criteria
400 women in each group
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
800
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
01/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Obstetrics & Gynaecology
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chelsea and Westminster Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary