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OpenTrials
Completed

NCT Number: NCT01574391

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Maternity Hospital

Dublin, Co Dublin, D 2, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturients receiving epidural analgesia for labour

Exclusion criteria

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

Treatment and study plan

Epidrum

Device

Epidrum is used

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

Primary outcomes

  1. RATE OF OCCURRENCE OF DURAL PUNCTURE

    Time frame: FIRST 48 HRS

Secondary outcomes

  1. RATE OF EPIDURAL BLOOD PATCH

    Time frame: I MONTH AFTER LAST PATIENT RECRUITED

  2. RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER

    Time frame: 24 HOURS

  3. RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR

    Time frame: 24

Sponsors and collaborators

Lead sponsor

National Maternity Hospital, Ireland

Other

Registry information

Official study title

A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.