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

ISRCTN ISRCTN84934115
DOI https://doi.org/10.1186/ISRCTN84934115
Secondary identifying numbers N0047111205
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
16/12/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr JS Thomas
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA study of maternal recall of risk information given prior to regional analgesia
Study objectivesWhat 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Regional analgesia
InterventionRecruitment - 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 typeOther
Primary outcome measureTo improve the recall of risk information on women receiving regional analgesia (epidural).
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2002
Completion date01/04/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsAim is to have 150 patients in both groups.
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2002
Date of final enrolment01/04/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Birmingham Women's Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan