Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436160509
Study information
Scientific title
Acronym
Study hypothesis
The aim of this study is to determine the efficiency of Hudson and Rebreathing oxygen facial mask in terms of fetal oxygen delivery.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy and Childbirth: Anaesthesia
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The oxygen of umbilical vein, and umbilical artery blood result observations are made by an independent observer (which is a routine procedure).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2004
Overall trial end date
01/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients requiring elective caesarean section under regional anaesthesia.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Total Target Recruitment: 40
Participant exclusion criteria
1. ASA III
2. Failure to attain the level of block (touch to T5)
3. Any intravenous analgesia or anaesthesia are given before the birth of the child
Recruitment start date
01/12/2004
Recruitment end date
01/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Labour Ward
Leeds
LS9 7TF
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
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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