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
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