Post-Dural Puncture HeadacheEPiMAPNCT02362828
EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics
An observational study of Post-Dural Puncture Headache, run by European Society of Anaesthesiology at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- How many people
- 1,110 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All women ≥ 18 years old, who develop classical symptoms of post-dural puncture headache after epidural anaesthesia for labour or for caesarean section.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- 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
- Medical subject headings
- Post-Dural Puncture Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 h after application of Epidural blood patch
Secondary outcomes (5)
European practices in the management of Post Dural Puncture Headache (PDPH)
Measured: 24 h after application of Epidural blood patch
Incidence of significant Post Dural Puncture Headache (PDPH) and treatment failure in different countries in Europe
Measured: 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
Measured: 24 h after application of Epidural blood patch
Complications and side effects of Epidural blood patch (EBP)
Complications include : Chronic headache and backache, neurological injuries, audiological or visual other chronic impairments
Measured: 24 h after application of Epidural blood patch
Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries
Measured: 24 h after application of Epidural blood patch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anil Gupta, MD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362828
- Sponsor's protocol ID
- EPiMAP Obstetrics
- Acronym
- EPiMAP
- Status last verified
- Dec 2018
- First submitted
- 9 Feb 2015
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
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 33039123Gupta 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02362828
- Acronym / sponsor ID
- EPiMAP / EPiMAP Obstetrics
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All women ≥ 18 years old, who develop classical symptoms of post-dural puncture headache after epidural anaesthesia for labour or for caesarean section.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Variation in practices for management of Accidental Dural Puncture (ADP) in different European countries
Time frame: 24 h after application of Epidural blood patch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Results publication: PubMed 33039123Gupta 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.
- Derived from this study: PubMed 36064491Gupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Gupta, MD study chair
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Dural Puncture Headache, run by European Society of Anaesthesiology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02362828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.