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Trials / Completed

CompletedNCT02362828

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
Phase
Study type
Observational
Enrollment
1,110 (actual)
Sponsor
European Society of Anaesthesiology · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2016-01-01
Primary completion
2018-12-31
Completion
2019-03-31
First posted
2015-02-13
Last updated
2022-02-15

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02362828. Inclusion in this directory is not an endorsement.