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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
Sponsor:
Information provided by (Responsible Party):
DR ROGER MCMORROW, National Maternity Hospital, Ireland

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care Device: Epidrum Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: EPIDRUM
EPIDRUM DEVICE IS USED TO SITE THE EPIDURALS IN THE PATIENTS RANDOMISED TO THIS ARM
 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


Outcome Measures
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Primary Outcome Measures :
  1. RATE OF OCCURRENCE OF DURAL PUNCTURE [ Time Frame: FIRST 48 HRS ]

Secondary Outcome Measures :
  1. RATE OF EPIDURAL BLOOD PATCH [ Time Frame: I MONTH AFTER LAST PATIENT RECRUITED ]
  2. RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER [ Time Frame: 24 HOURS ]
  3. RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR [ Time Frame: 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parturients receiving epidural analgesia for labour

Exclusion Criteria:

  • parturients that withold consent
  • parturients less than 18 years old
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Ireland
National Maternity Hospital
Dublin, Co Dublin, Ireland, D 2
Sponsors and Collaborators
National Maternity Hospital, Ireland
More Information
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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