Condition category
Pregnancy and Childbirth
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes