LabourNCT02131090
A Comparison of Intrapartum Epidural Fixation Devices: A Randomised Controlled Trial
A study testing Tegaderm TM, Lock-it Plus and Epifix in people with Labour and Childbirth, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labour, Childbirth
- What is being tested?
- Tegaderm TM, Lock-it Plus and Epifix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age >18
- Patient in labour, requesting an epidural.
- Primi-parous women
- Multi-parous women
- BMI < 50
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St. Georges Hospital NHS Trust
London, Tooting, sw17 0QT
About this study
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.
Read more
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).
Read the detailed description
The null hypothesis is that there is no difference in epidural catheter migration between any of the epidural catheter fixation devices.
The study design has been chosen so that the researchers can fairly assess how different commercially available epidural fixation devices perform in the real life scenario of labour, a time when epidurals are particularly important to the well-being of a labouring woman. Three different epidural fixation methods will be studied. These three methods have been chosen because they are all already in use in different hospitals across the UK but have never been compared together.
- Women admitted to labour ward at St. George's Hospital will be invited to participate in the study. Written informed consent will be obtained from all potential participants.
- Women in labour who request an epidural will be randomly allocated to one of three different dressings used to secure the epidural. The epidural will be performed by the duty anaesthetist according to a standard practice. The three epidural dressings are: 3M Tegaderm, Smiths Medical Lockit Plus and Unomedical Epifix. All dressing will be applied in a standardised manner. Since 3M Tegaderm is the current dressing used at St. George's Hospital it will form the control group.
- Epidurals will be inserted by the duty anaesthetist using a standard technique and the appropriate dressing applied. In order to avoid bias women will not be informed which device they are to receive.
- Patient characteristics will be documented for each epidural, including length of catheter at skin at time of insertion, depth to epidural space, intervertebral interspace used (e.g. L3-4), patient position for epidural insertion (lateral or sitting), time and date of epidural insertion, patient body mass index (at booking). No identifying patient data will be recorded.
- If an epidural is removed before delivery or the epidural fixation device is altered then the reason for intervention will be documented e.g. inadequacy of epidural analgesia, loss of integrity of fixation device. Any specific events that precipitate problems with the epidural fixation devices will be documented e.g. discomfort at site of dressing on transfer of patient onto operating theatre table.
- After delivery of the baby, the epidural catheter will be removed. Removal will be encouraged within the first hour following delivery and before the patient has mobilised from their bed. If possible then the woman will adopt the same position (either sitting or lateral) for removal of the epidural as she was in for insertion. Removal of the catheter will either be by a midwife or the duty anaesthetist.
- After removal of the epidural the following patient characteristics will be collected by the midwife or anaesthetist removing the catheter: length of catheter at skin at time of removal, patient position for epidural removal (lateral or sitting), time and date of epidural removal, integrity of epidural dressing, whether the patient was transferred to the operating theatre table, any additional problems encountered with the epidural or dressing.
- No specific restrictions will be placed on participants following epidural insertion, other than those that are routine for all labouring women with epidurals. However any women who move off their bed and walk before removal of their epidural catheter will be excluded from the study, since walking may cause the epidural catheter to migrate more than it would do so usually during labour.
Data will be analysed to determine whether the null hypothesis is accepted or rejected. Information about the study and any conclusion drawn will be published locally and nationally in order to inform decision making regarding which epidural catheter fixation device is best suited to reduce epidural migration in labouring women.
- Conditions
- Labour, Childbirth
- Being tested
- Tegaderm TM, Lock-it Plus, Epifix
- Keywords
- Epidural, Catheter, Fixation, Device, Intrapartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaderm TMDevice
This is a generic adhesive dressing which is commonly used to secure epidural catheters.
Lock-it PlusDevice
Also called Manufactured by Smith's Medical
This dressing is specifically designed for securing epidural catheters. It is adhesive to the patient's back and has a plastic clamp through which the epidural catheter passes. Once closed, the clamp secures the catheter.
EpifixDevice
Also called Epifix is manufactured by Unomedical
This dressing is specifically designed to secure epidural catheters. It is adhesive to the patient's back and has a foam, moulded mechanism through which the catheter is passed. An adhesive flap folds over the whole mechanism to secure the catheter.
| Study group | Role | What they receive |
|---|---|---|
| Tegaderm TM | Experimental | Participants in this arm of the study will receive the Tegaderm dressing to secure the epidural catheter Receives: Device: Tegaderm TM |
| Lock-it Plus | Experimental | Participants in this arm of the study will receive the Lock-it Plus dressing to secure the epidural catheter Receives: Device: Lock-it Plus |
| Epifix | Experimental | Participants in this arm of the study will receive the Epifix dressing to secure the epidural catheter Receives: Device: Epifix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of epidural catheter in centimetres
Measured: Upon epidural removal within 1 hour from delivery
Secondary outcomes (4)
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'
Measured: Upon epidural removal within 1 hour from delivery
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'.
Measured: Upon epidural removal within 1 hour from delivery
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.
Measured: Upon epidural removal within 1 hour from delivery
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.
Measured: Upon epidural removal within 1 hour from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LabourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Odor, Study chair, St George's, University of Londonsohail Bampoe, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131090
- Sponsor's protocol ID
- Epi devices RCT
- Status last verified
- Nov 2014
- First submitted
- 31 Mar 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intrapartum Epidural Fixation Devices: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02131090
- Acronym / sponsor ID
- Epi devices RCT
- Conditions
- Labour, Childbirth
- Keywords
- Epidural, Catheter, Fixation, Device, Intrapartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The null hypothesis is that there is no difference in epidural catheter migration between any of the epidural catheter fixation devices.
The study design has been chosen so that the researchers can fairly assess how different commercially available epidural fixation devices perform in the real life scenario of labour, a time when epidurals are particularly important to the well-being of a labouring woman. Three different epidural fixation methods will be studied. These three methods have been chosen because they are all already in use in different hospitals across the UK but have never been compared together.
- Women admitted to labour ward at St. George's Hospital will be invited to participate in the study. Written informed consent will be obtained from all potential participants.
- Women in labour who request an epidural will be randomly allocated to one of three different dressings used to secure the epidural. The epidural will be performed by the duty anaesthetist according to a standard practice. The three epidural dressings are: 3M Tegaderm, Smiths Medical Lockit Plus and Unomedical Epifix. All dressing will be applied in a standardised manner. Since 3M Tegaderm is the current dressing used at St. George's Hospital it will form the control group.
- Epidurals will be inserted by the duty anaesthetist using a standard technique and the appropriate dressing applied. In order to avoid bias women will not be informed which device they are to receive.
- Patient characteristics will be documented for each epidural, including length of catheter at skin at time of insertion, depth to epidural space, intervertebral interspace used (e.g. L3-4), patient position for epidural insertion (lateral or sitting), time and date of epidural insertion, patient body mass index (at booking). No identifying patient data will be recorded.
- If an epidural is removed before delivery or the epidural fixation device is altered then the reason for intervention will be documented e.g. inadequacy of epidural analgesia, loss of integrity of fixation device. Any specific events that precipitate problems with the epidural fixation devices will be documented e.g. discomfort at site of dressing on transfer of patient onto operating theatre table.
- After delivery of the baby, the epidural catheter will be removed. Removal will be encouraged within the first hour following delivery and before the patient has mobilised from their bed. If possible then the woman will adopt the same position (either sitting or lateral) for removal of the epidural as she was in for insertion. Removal of the catheter will either be by a midwife or the duty anaesthetist.
- After removal of the epidural the following patient characteristics will be collected by the midwife or anaesthetist removing the catheter: length of catheter at skin at time of removal, patient position for epidural removal (lateral or sitting), time and date of epidural removal, integrity of epidural dressing, whether the patient was transferred to the operating theatre table, any additional problems encountered with the epidural or dressing.
- No specific restrictions will be placed on participants following epidural insertion, other than those that are routine for all labouring women with epidurals. However any women who move off their bed and walk before removal of their epidural catheter will be excluded from the study, since walking may cause the epidural catheter to migrate more than it would do so usually during labour.
Data will be analysed to determine whether the null hypothesis is accepted or rejected. Information about the study and any conclusion drawn will be published locally and nationally in order to inform decision making regarding which epidural catheter fixation device is best suited to reduce epidural migration in labouring women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tegaderm TM | Experimental | Device: Tegaderm TMParticipants in this arm of the study will receive the Tegaderm dressing to secure the epidural catheter |
| Lock-it Plus | Experimental | Device: Lock-it PlusParticipants in this arm of the study will receive the Lock-it Plus dressing to secure the epidural catheter |
| Epifix | Experimental | Device: EpifixParticipants in this arm of the study will receive the Epifix dressing to secure the epidural catheter |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age >18
- Patient in labour, requesting an epidural.
- Primi-parous women
- Multi-parous women
- BMI < 50
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegaderm TMThis is a generic adhesive dressing which is commonly used to secure epidural catheters. | Device | Tegaderm TM |
| Lock-it PlusAlso: Manufactured by Smith's MedicalThis dressing is specifically designed for securing epidural catheters. It is adhesive to the patient's back and has a plastic clamp through which the epidural catheter passes. Once closed, the clamp secures the catheter. | Device | Lock-it Plus |
| EpifixAlso: Epifix is manufactured by UnomedicalThis dressing is specifically designed to secure epidural catheters. It is adhesive to the patient's back and has a foam, moulded mechanism through which the catheter is passed. An adhesive flap folds over the whole mechanism to secure the catheter. | Device | Epifix |
Primary outcome
Migration of epidural catheter in centimetres
Time frame: Upon epidural removal within 1 hour from delivery
4 secondary outcomes
Comfort of each fixation device for women during labour.
Time frame: Upon epidural removal within 1 hour from delivery
Structural integrity of each dressing.
Time frame: Upon epidural removal within 1 hour from delivery
Rate of epidural failures associated with each fixation device.
Time frame: Upon epidural removal within 1 hour from delivery
Effect of Body Mass Index on dressing integrity
Time frame: Upon epidural removal within 1 hour from delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Odor study chair
St George's, University of London
sohail Bampoe principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegaderm TM, Lock-it Plus and Epifix in people with Labour and Childbirth, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration of epidural catheter in centimetres (time frame: Upon epidural removal within 1 hour from delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.