A study of maternal recall of risk information given prior to regional analgesia
| ISRCTN | ISRCTN84934115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84934115 |
| Protocol serial number | N0047111205 |
| Sponsor | Department of Health (UK) |
| Funder | Birmingham Women's Healthcare NHS Trust (UK) |
- 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
Scientific
Anaesthetist Specialist Registrar
Birmingham Women's Hospital
Edgbaston
Birmingham
B15 2TG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A study of maternal recall of risk information given prior to regional analgesia |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
To improve the recall of risk information on women receiving regional analgesia (epidural). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 300 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 01/04/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom
B15 2TG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
