NCT02362828

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,110

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

February 15, 2022

Status Verified

December 1, 2018

Enrollment Period

3 years

First QC Date

February 9, 2015

Last Update Submit

January 31, 2022

Conditions

Post-Dural Puncture Headache

Keywords

Post-Dural Puncture HeadacheBlood Patch, epiduralObstetricsEuropean Society of Anaesthesiology (ESA)epidemiologyAccidental Dural Puncture (ADP)Anaesthesiachildbirth complicationepidural analgesiapostdural puncture headacheprophylactic epidural blood patchepidural

Outcome Measures

Primary Outcomes (1)

  • To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache

    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 Outcomes (5)

  • European practices in the management of Post Dural Puncture Headache (PDPH)

    24 h after application of Epidural blood patch

  • Incidence of significant Post Dural Puncture Headache (PDPH) and treatment failure in different countries in Europe

    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

    24 h after application of Epidural blood patch

  • Complications and side effects of Epidural blood patch (EBP)

    24 h after application of Epidural blood patch

  • Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries

    24 h after application of Epidural blood patch

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Hospital

Stockholm, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 33039123RESULT

  • 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.

    PMID: 36064491DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anil Gupta, MD

    Karolinska University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 13, 2015

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

February 15, 2022

Record last verified: 2018-12

Locations

SE(1)