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CompletedNCT02362828EPiMAPUpdated Feb 15, 2022

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

An observational study in Post-Dural Puncture Headache, sponsored by European Society of Anaesthesiology. Completed at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by European Society of Anaesthesiology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,110
Ages
18 Years and older
Sex
Female
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Study 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.
Read the 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.

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Conditions studied

  • Post-Dural Puncture Headache

Keywords

  • 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
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In context

Post-Dural Puncture Headache

125 studies on the registry are indexed under Post-Dural Puncture Headache; 25 are open to participants now.

This study's enrollment of 1,110 is above the median of 188 across 34 observational studies indexed under Post-Dural Puncture Headache.

Browse Post-Dural Puncture Headache studies →

Lead sponsor

European Society of Anaesthesiology is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,110 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: 24 h after application of Epidural blood patch

Secondary outcomes

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

    Time frame: 24 h after application of Epidural blood patch

  2. 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

  3. 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

  4. Complications and side effects of Epidural blood patch (EBP)

    Complications include : Chronic headache and backache, neurological injuries, audiological or visual other chronic impairments

    Time frame: 24 h after application of Epidural blood patch

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

    Time frame: 24 h after application of Epidural blood patch

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Study locations

1 site
  • Karolinska Hospital
    Stockholm, Sweden
08

References and documents

Publications

  • 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. PubMed 33039123 ↗
  • 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. PubMed 36064491 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02362828
Lead sponsor
European Society of Anaesthesiology
Responsible party
Sponsor
First posted
Feb 13, 2015
Start date
Jan 2016
Primary completion
Dec 31, 2018
Completion
Mar 31, 2019
Last update
Feb 15, 2022

Study contacts

Anil Gupta, MD
study chair · Karolinska University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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