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

January 31, 2022 updated by: European Society of Anaesthesiology

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 h after application of Epidural blood patch

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European practices in the management of Post Dural Puncture Headache (PDPH)
Time Frame: 24 h after application of Epidural blood patch
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
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
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
24 h after application of Epidural blood patch
Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries
Time Frame: 24 h after application of Epidural blood patch
24 h after application of Epidural blood patch

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Anaesthesiology

Investigators

  • Study Chair: Anil Gupta, MD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPiMAP Obstetrics

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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