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EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics (EPiMAP)

This study is currently recruiting participants.
Verified July 2017 by European Society of Anaesthesiology
Sponsor:
ClinicalTrials.gov Identifier:
NCT02362828
First Posted: February 13, 2015
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
European Society of Anaesthesiology
  Purpose

The aims of EPiMAP Obstetrics are:

  • to identify risk factors for failure of epidural blood patch in the obstetric population for management of post dural puncture headache.
  • to describe European practices in the management of accidental dural puncture in the Obstetric population.

Condition
Post-Dural Puncture Headache

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics: European Prospective Multicentre Observational Audit to MAP Out Current Practices in the Management of Patients Who Had Accidental Dural Puncture During EPIdural Insertion

Resource links provided by NLM:


Further study details as provided by European Society of Anaesthesiology:

Primary Outcome Measures:
  • To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache [ Time Frame: 24 h after application of Epidural blood patch ]
    To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache, in the obstetric population. Failure would be defined as lack of reduction in pain intensity by at least 50% at 24 h after application of EBP, compared to worst pain before EBP or a visual analogue pain score (VAS pain) of > 3 at 24 h.


Secondary Outcome Measures:
  • European practices in the management of Post Dural Puncture Headache (PDPH) [ Time Frame: 24 h after application of Epidural blood patch ]
  • Incidence of significant Post Dural Puncture Headache (PDPH) and treatment failure in different countries in Europe [ Time Frame: 24 h after application of Epidural blood patch ]
  • Timing of the procedure (after diagnosis of PDPH) and the volume of blood injected in relation to success or failure [ Time Frame: 24 h after application of Epidural blood patch ]
  • Complications and side effects of Epidural blood patch (EBP) [ Time Frame: 24 h after application of Epidural blood patch ]
    Complications include : Chronic headache and backache, neurological injuries, audiological or visual other chronic impairments

  • Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries [ Time Frame: 24 h after application of Epidural blood patch ]

Estimated Enrollment: 1200
Study Start Date: January 2016
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
Detailed Description:

The primary aim of this prospective, international audit of practice is to identify risk factors for failure of epidural blood patch (EBP) in the Obstetric population after accidental dural puncture (ADP) with an epidural needle. Other aims are to describe the epidemiology, management principles, side effects and complications of ADP and longer-term effects of ADP on patients undergoing Obstetric anaesthesia and analgesia. Expectation is that this audit of practice will provide important information in understanding the reasons for failure of EBP and subsequently to better manage parturients affected by this debilitating complication.

Postdural puncture headache (PDPH) is the most common serious complication of accidental dural puncture (ADP), and feared by every Anaesthesiologist. It is associated with significant peri-partum maternal distress, and poor bonding with the baby, which in turn leads to physical disability for the mother and psychological and social implications for the whole family. It is estimated that about 10,000 parturients in Europe may have an accidental dural puncture (ADP) each year. Attitudes and practices in the management of ADP are based on small studies, and sometimes driven by experience rather than evidence. Although several methods have been described in the literature to treat PDPH, one common method used is an epidural blood patch (EBP). This is believed to be successful in about 60-80% of parturients on the first attempt, but results from most studies are based on a small numbers of patients. The reasons and predisposing factors for success and failure of different management strategies, specifically EBP, therefore needs to be investigated and described. Large observational studies on post-dural puncture headache in the Obstetric population are singularly absent from the literature.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All women ≥ 18 years old, who develop classical symptoms of post-dural puncture headache after epidural anaesthesia for labour or for caesarean section.
Criteria

Inclusion Criteria:

  • All women ≥ 18 years old, who develop classical symptoms of post-dural puncture headache after epidural anaesthesia for labour or for caesarean section.

Exclusion Criteria:

  • Post-dural puncture headache following deliberate dural puncture with a spinal needle in women where there was no observed accidental dural puncture with an epidural needle.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362828


Contacts
Contact: Brigitte Leva +3222109414 brigitte.leva@esahq.org
Contact: Benoit Plichon +3227433291 research@esahq.org

Locations
Sweden
Karolinska Hospital Recruiting
Stockholm, Sweden
Sponsors and Collaborators
European Society of Anaesthesiology
Investigators
Study Chair: Anil Gupta, MD Karolinska University Hospital
  More Information

Additional Information:
Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT02362828     History of Changes
Other Study ID Numbers: EPiMAP Obstetrics
First Submitted: February 9, 2015
First Posted: February 13, 2015
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by European Society of Anaesthesiology:
Post-Dural Puncture Headache
Blood Patch, epidural
Obstetrics
European Society of Anaesthesiology (ESA)
epidemiology
Accidental Dural Puncture (ADP)
Anaesthesia
childbirth complication
epidural analgesia
postdural puncture headache
prophylactic epidural blood patch
epidural

Additional relevant MeSH terms:
Headache
Wounds and Injuries
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases