A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour
This study is currently recruiting participants.
Verified April 2012 by National Maternity Hospital, Ireland
Sponsor:
National Maternity Hospital, Ireland
Information provided by (Responsible Party):
DR ROGER MCMORROW, National Maternity Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01574391
First received: April 8, 2012
Last updated: April 9, 2012
Last verified: April 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 8, 2012 | ||||||||
| Last Updated Date | April 9, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
RATE OF OCCURRENCE OF DURAL PUNCTURE [ Time Frame: FIRST 48 HRS ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01574391 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour | ||||||||
| Official Title ICMJE | A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY. | ||||||||
| 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 Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care | ||||||||
| Intervention ICMJE | Device: Epidrum
Epidrum is used
Other Name: Epidrum is the trade name of the device manufactured by Exmore Plastics Uk |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | July 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Ireland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01574391 | ||||||||
| Other Study ID Numbers ICMJE | NMHEPI-12 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | DR ROGER MCMORROW, National Maternity Hospital, Ireland | ||||||||
| Study Sponsor ICMJE | National Maternity Hospital, Ireland | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | National Maternity Hospital, Ireland | ||||||||
| Verification Date | April 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||