Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care Clinical Trial
Official title:
A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY.
| Verified date | April 2015 |
| Source | National Maternity Hospital, Ireland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Ireland: Irish Medicines Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | August 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Parturients receiving epidural analgesia for labour Exclusion Criteria: - parturients that withold consent - parturients less than 18 years old |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Ireland | National Maternity Hospital | Dublin | Co Dublin |
| Lead Sponsor | Collaborator |
|---|---|
| National Maternity Hospital, Ireland |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | RATE OF OCCURRENCE OF DURAL PUNCTURE | FIRST 48 HRS | No | |
| Secondary | RATE OF EPIDURAL BLOOD PATCH | I MONTH AFTER LAST PATIENT RECRUITED | No | |
| Secondary | RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER | 24 HOURS | No | |
| Secondary | RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR | 24 | No |