EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics (EPiMAP)
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|ClinicalTrials.gov Identifier: NCT02362828|
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : July 28, 2017
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.
|Condition or disease|
|Post-Dural Puncture Headache|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official 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|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- 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 ]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.
- European practices in the management of Post Dural Puncture Headache (PDPH) [ 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 ]
- 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 ]
- Complications and side effects of Epidural blood patch (EBP) [ Time Frame: 24 h after application of Epidural blood patch ]Complications 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 countries [ Time Frame: 24 h after application of Epidural blood patch ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362828
|Contact: Brigitte Levafirstname.lastname@example.org|
|Contact: Benoit Plichonemail@example.com|
|Study Chair:||Anil Gupta, MD||Karolinska University Hospital|