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

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.

Study Overview

• Status: Completed
• Conditions: Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care
• Intervention / Treatment: Device: Epidrum

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co Dublin
    • Dublin, Co Dublin, Ireland, D 2
      • National Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Parturients receiving epidural analgesia for labour

Exclusion Criteria:

• parturients that withold consent
• parturients less than 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
RATE OF OCCURRENCE OF DURAL PUNCTURE	FIRST 48 HRS

Secondary Outcome Measures

Outcome Measure	Time Frame
RATE OF EPIDURAL BLOOD PATCH	I MONTH AFTER LAST PATIENT RECRUITED
RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER	24 HOURS
RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR	24

Collaborators and Investigators

• Sponsor: National Maternity Hospital, Ireland

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 8, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: NMHEPI-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No