We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574391
First Posted: April 10, 2012
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DR ROGER MCMORROW, National Maternity Hospital, Ireland
  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
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.

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

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 300
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: July 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Ireland
National Maternity Hospital
Dublin, Co Dublin, Ireland, D 2
Sponsors and Collaborators
National Maternity Hospital, Ireland
  More Information

Responsible Party: DR ROGER MCMORROW, National Maternity Hospital, Ireland
ClinicalTrials.gov Identifier: NCT01574391     History of Changes
Other Study ID Numbers: NMHEPI-12
First Submitted: April 8, 2012
First Posted: April 10, 2012
Last Update Posted: April 14, 2015
Last Verified: April 2015