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

Not Applicable

Completed

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

• Registration Number: NCT01574391
• Lead Sponsor: National Maternity Hospital, Ireland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-08
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Parturients receiving epidural analgesia for labour

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPIDRUM	Epidrum	EPIDRUM DEVICE IS USED TO SITE THE EPIDURALS IN THE PATIENTS RANDOMISED TO THIS ARM

Primary Outcome Measures

Name	Time	Method
RATE OF OCCURRENCE OF DURAL PUNCTURE	FIRST 48 HRS

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Maternity Hospital; 🇮🇪 Dublin, Co Dublin, Ireland