A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour
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ClinicalTrials.gov Identifier: NCT01574391 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : April 14, 2015
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Condition or disease | Intervention/treatment | Phase |
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Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care | Device: Epidrum | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY. |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | August 2012 |
Arm | Intervention/treatment |
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Active Comparator: EPIDRUM
EPIDRUM DEVICE IS USED TO SITE THE EPIDURALS IN THE PATIENTS RANDOMISED TO THIS ARM
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Device: Epidrum
Epidrum is used
Other Name: Epidrum is the trade name of the device manufactured by Exmore Plastics Uk |
No Intervention: Control
This arm is the control where normal technique is used
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- RATE OF OCCURRENCE OF DURAL PUNCTURE [ Time Frame: FIRST 48 HRS ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Parturients receiving epidural analgesia for labour
Exclusion Criteria:
- parturients that withold consent
- parturients less than 18 years old

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574391
Ireland | |
National Maternity Hospital | |
Dublin, Co Dublin, Ireland, D 2 |
Responsible Party: | DR ROGER MCMORROW, National Maternity Hospital, Ireland |
ClinicalTrials.gov Identifier: | NCT01574391 |
Other Study ID Numbers: |
NMHEPI-12 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | April 14, 2015 |
Last Verified: | April 2015 |