Condition category
Pregnancy and Childbirth
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gordon Lyons

ORCID ID

Contact details

Labour Ward
Level 5
Gledhow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 5371 ext. 5371

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

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

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

Publication citations

Additional files

Editorial Notes