Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/12/2014
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 JS Thomas

ORCID ID

Contact details

Anaesthetist Specialist Registrar
Birmingham Women's Hospital
Edgbaston
Birmingham
B15 2TG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0047111205

Study information

Scientific title

A study of maternal recall of risk information given prior to regional analgesia

Acronym

Study hypothesis

What is the baseline ability to recall risk information and can this be improved by changing the way the information is imparted to mothers? This will be tested by giving mothers a consent form to read which contains the risk information.

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: Regional analgesia

Intervention

Recruitment - Mothers will be approached in antenatal clinic (34 week appointment). All mothers who have no previous experience of epidurals will be eligible. Patient information sheets will be given to them and if they are interested then they will be asked to sign a consent form.

Randomisation - If the mothers then want an epidural during labour, they will be randomised by the on call registrar anaesthetist by picking a trial envelope. Half will contain a blank piece of paper and the other half will have consent for epidural analgesia forms. Group A (blank paper) - These mothers will be treated normally by receiving the risk information verbally from the anaesthetist before they take verbal consent for the epidural. Group B (consent form) - This group of mothers will receive the same verbal information whilst they read the consent form. They will sign a written consent for epidural analgesia. Interview - There is a normal daily ward round of all patients who have received anaesthetic input in the previous 24 h. All study patterns will be followed up on this ward round. They will receive the normal follow up AFTER they have been asked how many pieces of risk information they can correctly recall. The interviewer will be blinded as to which group the patient is in. Analysis - The data will be collated, anonymised and analysed to give us the average scores of each group along with any trend information present.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To improve the recall of risk information on women receiving regional analgesia (epidural).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2002

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Aim is to have 150 patients in both groups.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2002

Recruitment end date

01/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's Hospital
Birmingham
B15 2TG
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

Hospital/treatment centre

Funder name

Birmingham Women's Healthcare NHS Trust (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