NCT01574391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

April 8, 2012

Last Update Submit

April 13, 2015

Conditions

Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care

Outcome Measures

Primary Outcomes (1)

  • RATE OF OCCURRENCE OF DURAL PUNCTURE

    FIRST 48 HRS

Secondary Outcomes (3)

  • 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

Study Arms (2)

EPIDRUM

ACTIVE COMPARATOR

EPIDRUM DEVICE IS USED TO SITE THE EPIDURALS IN THE PATIENTS RANDOMISED TO THIS ARM

Device: Epidrum

Control

NO INTERVENTION

This arm is the control where normal technique is used

Interventions

EpidrumDEVICE

Epidrum is used

Also known as: Epidrum is the trade name of the device manufactured by Exmore Plastics Uk
EPIDRUM

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parturients receiving epidural analgesia for labour

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Maternity Hospital

Dublin, Co Dublin, D 2, Ireland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR ROGER MCMORROW

Study Record Dates

First Submitted

April 8, 2012

First Posted

April 10, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

IE(1)