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

NCT ID: NCT01574391

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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EPIDRUM

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

Group Type ACTIVE_COMPARATOR

Epidrum

Intervention Type DEVICE

Epidrum is used

Control

This arm is the control where normal technique is used

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Epidrum

Epidrum is used

Intervention Type DEVICE

Other Intervention Names

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Epidrum is the trade name of the device manufactured by Exmore Plastics Uk

Eligibility Criteria

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Inclusion Criteria

* Parturients receiving epidural analgesia for labour

Exclusion Criteria

* parturients that withold consent
* parturients less than 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Maternity Hospital, Ireland

OTHER

Sponsor Role lead

Responsible Party

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DR ROGER MCMORROW

DR ROGER MCMORROW

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Maternity Hospital

Dublin, Co Dublin, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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NMHEPI-12

Identifier Type: -

Identifier Source: org_study_id

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