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Register:	ClinicalTrials.gov
Last refreshed on:	21 February 2022
Main ID:	NCT02362828
Date of registration:	09/02/2015
Prospective Registration:	Yes
Primary sponsor:	European Society of Anaesthesiology
Public title:	EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics EPiMAP
Scientific title:	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
Date of first enrolment:	January 2016
Target sample size:	1110
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02362828
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Sweden

Contacts

Name:	Anil Gupta, MD
Address:
Telephone:
Email:
Affiliation:	Karolinska University Hospital

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Post-Dural Puncture Headache

Intervention(s)

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Complications and side effects of Epidural blood patch (EBP) [Time Frame: 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]

European practices in the management of Post Dural Puncture Headache (PDPH) [Time Frame: 24 h after application of Epidural blood patch]

Secondary ID(s)

EPiMAP Obstetrics

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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