Childbirth Clinical Trial
Official title:
A Comparison of Intrapartum Epidural Fixation Devices: A Randomised Controlled Trial
A number of methods are currently used to prevent movement of epidural catheters in women
during labour. These usually consist of sticky dressings applied to the patient's back. The
purpose of this study is to compare how much epidural catheters move when secured with three
commonly used different fixation dressings with the aim of identifying the best method of
securing epidural catheters.
Movement of epidural catheters has several clinical implications. Usually only a short
length of epidural catheter is left in the epidural space, and therefore any significant
movement could result in the catheter moving out of the epidural space leading to a loss of
the pain relieving effects of the epidural.
Once epidural failure has occurred due to catheter migration, a second catheter must be
inserted in order to re-establish pain relief and thus the patient is exposed to the risks
of epidural insertion for a second time.
If the researchers in this study can identify a method of fixing epidural catheters which
results in the least amount of catheter movement, then patients could benefit from more
reliable epidural pain relief, fewer repeated procedures and the risks associated with
repeated procedures.
The principle objective of the study is to determine which epidural fixation dressing
results in the least amount of epidural catheter movement from the time of epidural
insertion (during labour) to the time of epidural removal (after labour).
Status | Completed |
Enrollment | 160 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Age >18 - Patient in labour, requesting an epidural. - Primi-parous women - Multi-parous women - BMI < 50 Exclusion Criteria: - BMI >50 - Documented diagnosis of scoliosis and/or other significant lumbar spinal pathology - Previous lumbar spinal surgery - Any contraindication to epidural analgesia - Unable to consent for inclusion in study - Admitted for termination of pregnancy or intra-uterine death |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | St. Georges Hospital NHS Trust | London | Tooting |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Migration of epidural catheter in centimetres | Upon epidural removal within 1 hour from delivery | No | |
Secondary | Comfort of each fixation device for women during labour. | A simple questionnaire incorporated into the data collection sheet, section 3. Women will be asked whether the dressing was comfortable and their response will be recorded as either 'comfortable' or 'uncomfortable' | Upon epidural removal within 1 hour from delivery | No |
Secondary | Structural integrity of each dressing. | This will be assessed using a simple questionnaire as part of the data collection form in section 2. The midwife removing the epidural will record whether the dressing is either 'intact', 'partially peeled off' or 'completely peeled off'. | Upon epidural removal within 1 hour from delivery | No |
Secondary | Rate of epidural failures associated with each fixation device. | Assessed using the data collection questionnaire section 3. Data collectors will answer two questions: Has the epidural block partially failed? Yes or No. Partial failure is defined as pain despite epidural top ups, but not requiring the epidural to be re-sited. Has the epidural block completely failed? Yes or no. An epidural is defined as 'completely failed' if it needs to be re-sited at any point during labour. |
Upon epidural removal within 1 hour from delivery | No |
Secondary | Effect of Body Mass Index on dressing integrity | The Body Mass Index (BMI) of each participant will be recorded. This data will be correlated with each dressing type and data collected regarding device integrity as collected in the data collection form section 2 as previously described. | Upon epidural removal within 1 hour from delivery | No |
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