Epidural related maternal temperature and neonatal outcome: a randomised controlled study

ISRCTN	ISRCTN33477809
DOI	https://doi.org/10.1186/ISRCTN33477809
Protocol serial number	N0060148249
Sponsor	Department of Health
Funders	Chelsea and Westminster Healthcare NHS Trust (UK), NHS R&D Support Funding (UK)

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

Dept of Obstetrics & Gynaecology
Chelsea & Westminster Hospial
369 Fulham Road
London
SW10 9NH
United Kingdom

Phone	+44 (0)20 8846 7892
Email	p.steer@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Single blind interventional randomised controlled trial.
Secondary study design	Randomised controlled trial
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(s)	Differences in mean NACS score at 24 +/- 6 hours between the intervention and control group
Key secondary outcome measure(s)	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
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 sample size at registration	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

United Kingdom
England

Study participating centre

Dept of Obstetrics & Gynaecology

London
SW10 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan