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

NCT ID: NCT02362828

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Dural Puncture Headache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Society of Anaesthesiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anil Gupta, MD

Role: STUDY_CHAIR

Karolinska University Hospital

Locations

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Karolinska Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Gupta A, von Heymann C, Magnuson A, Alahuhta S, Fernando R, Van de Velde M, Mercier FJ, Schyns-van den Berg AMJV; EPiMAP collaborators. Management practices for postdural puncture headache in obstetrics: a prospective, international, cohort study. Br J Anaesth. 2020 Dec;125(6):1045-1055. doi: 10.1016/j.bja.2020.07.061. Epub 2020 Oct 8.

Reference Type RESULT
PMID: 33039123 (View on PubMed)

Gupta A, Van de Velde M, Magnuson A, von Heymann C, Guasch E, Alahuhta S, Mercier FJ, Schyns-van den Berg AMJV; European Practices in the Management of Accidental Dural Puncture in Obstetrics Investigators. Factors associated with failed epidural blood patch after accidental dural puncture in obstetrics: a prospective, multicentre, international cohort study. Br J Anaesth. 2022 Nov;129(5):758-766. doi: 10.1016/j.bja.2022.06.040. Epub 2022 Sep 3.

Reference Type DERIVED
PMID: 36064491 (View on PubMed)

Other Identifiers

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EPiMAP Obstetrics

Identifier Type: -

Identifier Source: org_study_id

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