A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Maternity Hospital, Ireland.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
DR ROGER MCMORROW, National Maternity Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01574391
First received: April 8, 2012
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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 Intervention
Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care
Device: Epidrum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Further study details as provided by National Maternity Hospital, Ireland:

Primary Outcome Measures:
  • RATE OF OCCURRENCE OF DURAL PUNCTURE [ Time Frame: FIRST 48 HRS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RATE OF EPIDURAL BLOOD PATCH [ Time Frame: I MONTH AFTER LAST PATIENT RECRUITED ] [ Designated as safety issue: No ]
  • RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER [ Time Frame: 24 HOURS ] [ Designated as safety issue: No ]
  • RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR [ Time Frame: 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574391

Contacts
Contact: ROGER MCMORROW, MB BCH +353 861736873 mcmorrow.roger@gmail.com
Contact: MAIREAD DEIGHAN, MB BCH +44 7793006807 MAIREADEIGHAN@DOCTORS.ORG.UK

Locations
Ireland
National Maternity Hospital Recruiting
Dublin, Co Dublin, Ireland, D 2
Contact: MAIREAD DEIGHAN, MB BCH    +44 7793006807    MAIREADEIGHAN@DOCTORS.ORG.UK   
Principal Investigator: ROGER MCMORROW, MB BCH         
Sponsors and Collaborators
National Maternity Hospital, Ireland
  More Information

No publications provided

Responsible Party: DR ROGER MCMORROW, National Maternity Hospital, Ireland
ClinicalTrials.gov Identifier: NCT01574391     History of Changes
Other Study ID Numbers: NMHEPI-12
Study First Received: April 8, 2012
Last Updated: April 9, 2012
Health Authority: Ireland: Irish Medicines Board

ClinicalTrials.gov processed this record on October 16, 2014