Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
17/11/2010
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 S Saravanan

ORCID ID

Contact details

Obstetric Anaesthesia Office
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130343

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to determine whether ephedrine or phenylephrine or a combination provides the best prophylactic for prevention of hypotension after spinal anaesthesia

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Pregnancy and Childbirth: Anaesthesia

Intervention

Randomised controlled trial to determine whether ephedrine or phenylephrine or a combination provides the best prophylactic for prevention of hypotension after spinal anaesthesia.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Efficacy in preventing cardiovascular instability
Uterine arterial blood gas analysis
Incidence of nausea and vomiting under anaesthetic

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Women who have completed 36 weeks of normal pregnancy, fit and well normally and who are planned to have an elective caesarean section under spinal anaesthesia will be recruited

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Obstetric Anaesthesia Office
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16311286

Publication citations

  1. Results

    Saravanan S, Kocarev M, Wilson RC, Watkins E, Columb MO, Lyons G, Equivalent dose of ephedrine and phenylephrine in the prevention of post-spinal hypotension in Caesarean section., Br J Anaesth, 2006, 96, 1, 95-99, doi: 10.1093/bja/aei265.

Additional files

Editorial Notes