Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum CareNCT01574391
A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour
A study testing Epidrum in people with Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care, run by National Maternity Hospital, Ireland at 1 site in Ireland.
Trial summary
The purpose of this study is to determine whether the use of the Epidrum device to identify the epidural space in labouring parturients reduces morbidity, when compared to standard loss of resistance techniques. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care
- What is being tested?
- Epidrum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2012to Aug 2012
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parturients receiving epidural analgesia for labour
Who cannot join
- parturients that withold consent
- parturients less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY.
The purpose of this study is to determine whether the use of the Epidrum device to identify the epidural space in labouring parturients reduces morbidity, when compared to standard loss of resistance techniques.
- Conditions
- Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care
- Being tested
- Epidrum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidrumDevice
Also called Epidrum is the trade name of the device manufactured by Exmore Plastics Uk
Epidrum is used
| Study group | Role | What they receive |
|---|---|---|
| EPIDRUM | Active comparator | EPIDRUM DEVICE IS USED TO SITE THE EPIDURALS IN THE PATIENTS RANDOMISED TO THIS ARM Receives: Device: Epidrum |
| Control | No intervention | This arm is the control where normal technique is used |
What is being measured
The primary outcome is the main question the study is designed to answer.
RATE OF OCCURRENCE OF DURAL PUNCTURE
Measured: FIRST 48 HRS
Secondary outcomes (3)
RATE OF EPIDURAL BLOOD PATCH
Measured: I MONTH AFTER LAST PATIENT RECRUITED
RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER
Measured: 24 HOURS
RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR
Measured: 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum CareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Maternity Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ROGER MCMORROW, National Maternity Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574391
- Sponsor's protocol ID
- NMHEPI-12
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2012
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY.
- ClinicalTrials.gov ID
- NCT01574391
- Acronym / sponsor ID
- NMHEPI-12
- Conditions
- Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- National Maternity Hospital, IrelandUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Apr 2012 (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.
The purpose of this study is to determine whether the use of the Epidrum device to identify the epidural space in labouring parturients reduces morbidity, when compared to standard loss of resistance techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPIDRUM | Active comparator | Device: EpidrumEPIDRUM DEVICE IS USED TO SITE THE EPIDURALS IN THE PATIENTS RANDOMISED TO THIS ARM |
| Control | No intervention | –This arm is the control where normal technique is used |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parturients receiving epidural analgesia for labour
Key exclusion criteria (2 listed)
- parturients that withold consent
- parturients less than 18 years old
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 |
|---|---|---|
| EpidrumAlso: Epidrum is the trade name of the device manufactured by Exmore Plastics UkEpidrum is used | Device | EPIDRUM |
Primary outcome
RATE OF OCCURRENCE OF DURAL PUNCTURE
Time frame: FIRST 48 HRS
3 secondary outcomes
RATE OF EPIDURAL BLOOD PATCH
Time frame: I MONTH AFTER LAST PATIENT RECRUITED
RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER
Time frame: 24 HOURS
RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR
Time frame: 24
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 14 Apr 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidrum in people with Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care, run by National Maternity Hospital, Ireland at 1 site in Ireland.
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 1 inclusion and 2 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 14 Apr 2015. 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 Ireland. 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?
RATE OF OCCURRENCE OF DURAL PUNCTURE (time frame: FIRST 48 HRS). 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 14 Apr 2015.