Parturients in LabourAHEADNCT01682967
Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients
An observational study of Parturients in Labour, run by Örebro University, Sweden at 2 sites in Sweden.
Trial summary
Headache following accidental dural punction as during epidural analgesia can be severe and sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural puncture. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturients in Labour
- How many people
- 21 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2012to Sep 2015
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Experimental group: Parturients in labour with epidural and having PDPH Control group - EDA: Parturients in labour with epidural and NOT having PDPH Control group - No EDA: Parturients in labour without epidural and NOT having PDPH
Who may be able to join
- Healthy parturients No known hearing problems Understand Swedish language Informed consent
Who cannot join
- Taking steroid medication Having pre-eclampsia
Trial locations and contacts
2 sites in 1 country.
About this study
Headache following accidental dural punction as during epidural analgesia can be severe and sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural puncture. Although spontaneous resolution of headaches is common in most patients within 7 days, in 20% can they be persistent and in some very disabling. The exact reason for the characteristic headache is unknown, but it is believed to be the result of leakage of cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more severe and persistent the headache. This is why larger needles (lower gauge) are known to have a higher incidence of PDPH. However, the type of needle also seems to play an important role in the likelihood of PDPH.
Headache following accidental PDPH is very typical as it increases significantly when sitting or standing and often disappears completely on lying down. It is typically located in the back of the head, accentuated by light and often decreases with intake of large quantity of fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.
Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage, as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of clinical symptoms and signs of accidental PDPH.
Read the detailed description
Parturients who have received epidural analgesia during labour would be included in this study and these would comprise of:
- patients without clinical symptoms of postdural puncture headache
- patients with clinical symptoms of postdural puncture headache
In addition, a control group of parturients who have not received an epidural analgesia would constitute the control group.
All patients would have audiometry (oto-acoustic emission - OAE, and auditory steady state response - ASSR) done following diagnosis of PDPH. Subsequently, the patients would be observed for 24 h to assess whether the headache resolves spontaneously. A new audiometry would be done at this stage. Those patients with substantial evidence of PDPH at this stage would receive an epidural blood patch (EBP) and a new audiometric assessment would be made after 4 h and 24 h to assess whether any audiometric deficit has resolved or not. All patients would have a similar measurement of hearing after 3 months when it is believed that most patients have returned to normal hearing. In addition to audiometric analysis, patients would be asked to fill out a detailed PDPH questionnaire at the same time periods.
All measurements would be compared with patients who have received an EDA but without PDPH and those who have not received an EDA.
- Conditions
- Parturients in Labour
- Keywords
- Parturients, Analgesia, epidural, Headache, post-dural puncture
- Medical subject headings
- Agnosia, Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients suffering from PDPH would form this group | |
| Control group - Epidural | Patients who received an epidural during labour but did not have symptoms of PDPH would form this reference group | |
| Control Group without Epidural analgesia | Patients in labour who did not receive an EDA would form this cohort of controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-dural puncture headache
VAS pain (headache) 4 h after application of EBP
Measured: 4 h after epidural blood patch
Secondary outcomes (3)
Audiometric data
OAE and ASSR would be measured 4 h after application of EBP
Measured: 4 h following EBP
PDPH questionnaire
The PDPH questionnaire would be used to analyse pain and its characteristics 4 h after application of EBP
Measured: 4 h after application of EBP
Recurrence of Headache
The incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h
Measured: 24 h after application of EBP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parturients in LabourStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Anil Gupta, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682967
- Sponsor's protocol ID
- AHEAD-11
- Acronym
- AHEAD
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2012
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients
- ClinicalTrials.gov ID
- NCT01682967
- Acronym / sponsor ID
- AHEAD / AHEAD-11
- Conditions
- Parturients in Labour
- Keywords
- Parturients, Analgesia, epidural, Headache, post-dural puncture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Sep 2012 (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.
Headache following accidental dural punction as during epidural analgesia can be severe and sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural puncture. Although spontaneous resolution of headaches is common in most patients within 7 days, in 20% can they be persistent and in some very disabling. The exact reason for the characteristic headache is unknown, but it is believed to be the result of leakage of cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more severe and persistent the headache. This is why larger needles (lower gauge) are known to have a higher incidence of PDPH. However, the type of needle also seems to play an important role in the likelihood of PDPH.
Headache following accidental PDPH is very typical as it increases significantly when sitting or standing and often disappears completely on lying down. It is typically located in the back of the head, accentuated by light and often decreases with intake of large quantity of fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.
Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage, as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of clinical symptoms and signs of accidental PDPH.
Detailed description
Parturients who have received epidural analgesia during labour would be included in this study and these would comprise of:
- patients without clinical symptoms of postdural puncture headache
- patients with clinical symptoms of postdural puncture headache
In addition, a control group of parturients who have not received an epidural analgesia would constitute the control group.
All patients would have audiometry (oto-acoustic emission - OAE, and auditory steady state response - ASSR) done following diagnosis of PDPH. Subsequently, the patients would be observed for 24 h to assess whether the headache resolves spontaneously. A new audiometry would be done at this stage. Those patients with substantial evidence of PDPH at this stage would receive an epidural blood patch (EBP) and a new audiometric assessment would be made after 4 h and 24 h to assess whether any audiometric deficit has resolved or not. All patients would have a similar measurement of hearing after 3 months when it is believed that most patients have returned to normal hearing. In addition to audiometric analysis, patients would be asked to fill out a detailed PDPH questionnaire at the same time periods.
All measurements would be compared with patients who have received an EDA but without PDPH and those who have not received an EDA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | –Patients suffering from PDPH would form this group |
| Control group - Epidural | – | –Patients who received an epidural during labour but did not have symptoms of PDPH would form this reference group |
| Control Group without Epidural analgesia | – | –Patients in labour who did not receive an EDA would form this cohort of controls |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Experimental group: Parturients in labour with epidural and having PDPH Control group - EDA: Parturients in labour with epidural and NOT having PDPH Control group - No EDA: Parturients in labour without epidural and NOT having PDPH
Key inclusion criteria (1 listed)
- Healthy parturients No known hearing problems Understand Swedish language Informed consent
Key exclusion criteria (1 listed)
- Taking steroid medication Having pre-eclampsia
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
Post-dural puncture headache
Time frame: 4 h after epidural blood patch
VAS pain (headache) 4 h after application of EBP
3 secondary outcomes
Audiometric data
Time frame: 4 h following EBP
PDPH questionnaire
Time frame: 4 h after application of EBP
Recurrence of Headache
Time frame: 24 h after application of EBP
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 29 Sep 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parturients in Labour, run by Örebro University, Sweden at 2 sites 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Post-dural puncture headache (time frame: 4 h after epidural blood patch). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2015.