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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02362828
Acronym
EPiMAP
Enrollment
1110
Registered
2015-02-13
Start date
2016-01-31
Completion date
2019-03-31
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

None listed

Sponsors

European Society of Anaesthesiology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To examine the risk factors for failed epidural blood patch (EBP) following post-dural puncture headache24 h after application of Epidural blood patchTo 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

MeasureTime frameDescription
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 Europe24 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 failure24 h after application of Epidural blood patch
Complications and side effects of Epidural blood patch (EBP)24 h after application of Epidural blood patchComplications 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 countries24 h after application of Epidural blood patch

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026