Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/02/2014
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 Ian Taylor

ORCID ID

Contact details

Anaesthetics Department
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)23 9228 6000

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0187122160

Study information

Scientific title

Acronym

Study hypothesis

The majority of elective Caesarean section operations are performed using a spinal anaesthetic. One of the common problems with this technique is a fall in the patient's blood pressure - occurring in approximately 70% of cases. At present we closely monitor blood pressure and treat any fall with fluids and/or intravenous drugs (usually ephedrine) as it occurs.
The aim of this study is to assess whether or not the frequency of a fall in blood pressure can actually be avoided by the use of ephedrine before a drop occurs. Secondly, if prophylactic ephedrine is of benefit we hope to find out which is the best way to administer the drug: either by a bolus or by a continuous infusion.

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

1. Ephedrine infusion
2. Ephedrine bolus
3. Saline

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

18/11/2002

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

A total of 105 patients (35 per group) age >16 years.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

105

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

18/11/2002

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics Department
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Portsmouth NHS Research and Development Consortium (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