Post-Dural Puncture HeadacheNCT03550586
Long Term Outcomes Following a Post Dural Puncture Headache
An observational study of Post-Dural Puncture Headache, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
Epidural analgesia is considered a gold standard method for treatment of labor pain. One of the major risks with epidural analgesia is an accidental dural puncture, which leads to a post dural puncture headache. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Questionaires
- How many people
- 240 participants
- Where
- 2 sitesIsrael
- Study dates
- 24 Apr 2018to 1 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All women who developed a PDPH following an ADP between the years 2007-2017 at rabin medical center and at Assaf Harofeh Medical Center.
Who may be able to join
- All cases of parturients suffering from a PDPH during the years 2007-2017.
Who cannot join
- Women unable to be answer a questionnaire in Hebrew. Women under the age 18 Women suffering from a PDPH following spinal anesthesia for cesarean section.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Long Term Outcomes of Parturients Suffering From a Post Dural Puncture Headache Following an Accidental Dural Puncture (PDPH)
Epidural analgesia is considered a gold standard method for treatment of labor pain. One of the major risks with epidural analgesia is an accidental dural puncture, which leads to a post dural puncture headache. This headache is associated with significant maternal morbidity and can result in severe maternal consequences.
Post traumatic stress disorder (PTSD) is defined as an anxiety syndrome, resulting from a traumatic experience. Postpartum PTSD, is a form of PTSD that can occur in relation to a traumatic birth experience. As PDPH is unexpected and can cause severe maternal sequele, PDPH can exhibit a posttraumatic stress response. Therefore we hypothesize that parturients who suffered from a PDPH are at higher risk for developing PP-PTSD.
To date, very few reports have examined the long term outcomes of parturients suffering from a PDPH. As a follow up to the national survey of PDPH management in Israel the investigators aim, in this prospective multi center, observational study, to evaluate the long term outcomes of parturients suffering from a PDPH, including chronic headache, backache, postpartum depression, decreased breastfeeding and the development of PP PTSD.
Read the detailed description
Introduction:
Epidural analgesia is considered a gold standard method for treatment of labor pain . However one of the major risks with epidural analgesia is an accidental dural puncture, a common complication occurring in 0.4-6% of the obstetric population . ADP increases the risk of developing a post dural puncture headache (PDPH) in 50% of parturients. PDPH is defined as a postural headache that worsens within fifteen minutes of standing and is relieved in the supine position . PDPH results from a CSF leakage from the intrathecal space, causing a decrease in CSF volume and pressure .
PDPH is associated with significant maternal morbidity, prolonging hospital stay, preventing ambulation and impairing maternal neonatal bonding . Less frequently PDPH can cause severe maternal complications resulting in posterior reversible encephalopathic syndrome , pneumocephalus , or a subdural hematoma .
Treatment protocols for PDPH vary greatly, with numerous existing conservative/ invasive treatment options . Conservative treatment includes bed rest, fluids administration, non-steroidal anti-inflammatory drugs and caffeine intake. The most standard invasive method for treatment of PDPH with a reported success rate of 70-90% includes the epidural blood patch (EPD) which is applied by injecting autologous blood epidurally .
Several factors have been found to increase the risk for developing a PDPH and increasing the duration of a PDPH including young age, low BMI and previous history of anxiety or depression .
Posttraumatic stress disorder is classified as an anxiety syndrome one may develop in response to a traumatic experience. Clinical manifestations include persistent re-experience, avoidance of traumatic memories, hyperarousal and emotional numbing . In a retrospective analysis war related PTSD was not associated with increased risk of PDPH.
Post partum (PP) PTSD is a form of PTSD occurring in the postpartum period in relation to a traumatic birth . As PDPH is unexpected and can cause severe maternal sequele, PDPH can exhibit a posttraumatic stress response. Therefore the investigators hypothesize that parturients who suffered from a PDPH are at higher risk for developing PP-PTSD.
To date very few reports have examined the long term outcomes of parturients suffering from a PDPH associated with epidural analgesia. In a prospective, case control trial Webb et al demonstrated an increased risk for developing a chronic headache and backache in 40 parturients who suffered an accidental dural puncture with a large gauge needle . In a five year follow-up study examining long term consequences of PDPH, PDPH was associated with persistent headache and backache in the obstetric population. In a case control trial evaluating long term auditory function following EBP treatment for PDPH, a minor hearing loss was detected in the PDPH group . However, these studies had a small sample size.
As a follow up to the national survey of PDPH management in Israel the investigators aimed in this study to evaluate the long term consequences of PDPH including chronic headache, backache, postpartum depression (PPD), decreased breastfeeding and the development of PP PTSD.
Study Objective:
In this study the investigators intend to evaluate the long term sequelae of parturients who suffered from an accidental dural puncture and a subsequent PDPH.
Primary Aims:
This study's primary objective is to examine whether parturients suffering from a PDPH are at higher risk long-term for developing PP-PTSD than their counterparts.
Secondary aims:
Secondary aims include long term outcomes of parturients who suffered from PDPH:
- Chronic headache
- Chronic backache
- Comparing long term outcomes of parturients suffering from a PDPH with conservative treatment verses epidural blood patch treatment.
- PPD
- Breastfeeding outcomes including duration of breastfeeding
- Women will also be questioned about other labor experiences including analgesic consumption, breastfeeding outcome.
Study Design This study is a prospective multi center cohort, study. Following obtaining approval from the local Institutional Review Board at each center, all women who developed a PDPH following an ADP between the years 2007-2017 will be contacted by phone and verbal consent will be obtained for participation in the study. Each participant will be compared to two women receiving epidural analgesia on the same day as those women who suffered an ADP. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS)translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire . Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire . Parturients will also be asked about other labor experiences including analgesic consumption and breastfeeding outcome, in cases of breastfeeding cessation women will be asked an open-ended question about the reason for discontinuation.
Data collection:
Additional data will be collected from an electronic medical file database. Data collection will include; parturient's demographic data, obstetric data, in case of EBP treatment procedural data (level of injection, volume of blood injected, loss of resistance technique- air/saline, anesthesiologist experience, time of procedure, duration of procedure, technical difficulties, visual analogue score (VAS) upon lying down/ upon sitting up - before the EBP and upon release
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Questionaires
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionairesOther
Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS)translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire . Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire .
| Study group | Role | What they receive |
|---|---|---|
| Parturients suffering from a PDPH | Parturients suffering form a PDPH following an accidental dural puncture between the years 2007-2017 will be contacted by phone and verbal consent will be obtained for participation in the study. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire.Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire Receives: Other: Questionaires | |
| Parturients not suffering from a PDPH | This group will consistent of a control group of women receiving epidural analgesia on the same day as those women who suffered an ADP. This participants will be contacted by phone and verbal consent will be obtained for participation in the study. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire.Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire Receives: Other: Questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Traumatic Stress Disorder (PTSD) questionnaire score
The total PTSD questionnaire score using the validated PTSD questionnaire
Measured: Up to ten years postpartum (Answer at telephone survey)
Secondary outcomes (3)
The total Edinburgh Postnatal Depression Scale (EPDS) questionnaire score
Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale
Measured: Up to ten years postpartum (Answer at telephone survey)
The total score on the Brief Pain Inventory questionnaire
Parturients will be assed for chronic pain using the validated Brief Pain Inventory questionnaire questionnaire
Measured: Up to ten years postpartum (Answer at telephone survey)
The total score on the Oswestry low back pain questionnaire
Parturients will be assed for back pain using the validated Oswestry low back pain questionnaire
Measured: Up to ten years postpartum (Answer at telephone survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start24 Apr 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Assaf-Harofeh Medical Center
- Responsible party
- Sponsor
- Investigators
- Sharon O Zinger, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550586
- Sponsor's protocol ID
- 0536-17-RMC
- Status last verified
- Apr 2018
- First submitted
- 22 Apr 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradbury CL, Singh SI, Badder SR, Wakely LJ, Jones PM. Prevention of post-dural puncture headache in parturients: a systematic review and meta-analysis. Acta Anaesthesiol Scand. 2013 Apr;57(4):417-30. doi: 10.1111/aas.12047. Epub 2012 Dec 28.
PubMed 23278515Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.
PubMed 25146108Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
PubMed 26950232Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283.
PubMed 15814755Webb CA, Weyker PD, Zhang L, Stanley S, Coyle DT, Tang T, Smiley RM, Flood P. Unintentional dural puncture with a Tuohy needle increases risk of chronic headache. Anesth Analg. 2012 Jul;115(1):124-32. doi: 10.1213/ANE.0b013e3182501c06. Epub 2012 Mar 30.
PubMed 22467897Shah R, Kubisz-Pudelko A, Reid J. Posterior reversible encephalopathy syndrome following an inadvertent dural puncture during an emergency laparotomy for ischemic colitis - a case report. Local Reg Anesth. 2014 Jan 20;7:1-4. doi: 10.2147/LRA.S57660. eCollection 2014.
PubMed 24600245Gomez-Rios MA, Fernandez-Goti MC. Pneumocephalus after inadvertent dural puncture during epidural anesthesia. Anesthesiology. 2013 Feb;118(2):444. doi: 10.1097/ALN.0b013e31825e6ecc. No abstract available.
PubMed 22692380Liang MY, Pagel PS. Bilateral interhemispheric subdural hematoma after inadvertent lumbar puncture in a parturient. Can J Anaesth. 2012 Apr;59(4):389-93. doi: 10.1007/s12630-011-9664-6. Epub 2012 Jan 4.
PubMed 22215524Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.
PubMed 23450533Stannard D. Epidural blood patching for preventing and treating postdural puncture headache. J Perianesth Nurs. 2011 Dec;26(6):411-2. doi: 10.1016/j.jopan.2011.09.002. No abstract available.
PubMed 22099135Orbach-Zinger S, Eidelman LA, Livne MY, Matkovski O, Mangoubi E, Borovich A, Wazwaz SA, Ioscovich A, Zekry ZHB, Ariche K, Weiniger CF. Long-term psychological and physical outcomes of women after postdural puncture headache: A retrospective, cohort study. Eur J Anaesthesiol. 2021 Feb 1;38(2):130-137. doi: 10.1097/EJA.0000000000001297.
PubMed 32858584
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes of Parturients Suffering From a Post Dural Puncture Headache Following an Accidental Dural Puncture (PDPH)
- ClinicalTrials.gov ID
- NCT03550586
- Acronym / sponsor ID
- 0536-17-RMC
- Conditions
- Post-Dural Puncture Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- 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.
Epidural analgesia is considered a gold standard method for treatment of labor pain. One of the major risks with epidural analgesia is an accidental dural puncture, which leads to a post dural puncture headache. This headache is associated with significant maternal morbidity and can result in severe maternal consequences.
Post traumatic stress disorder (PTSD) is defined as an anxiety syndrome, resulting from a traumatic experience. Postpartum PTSD, is a form of PTSD that can occur in relation to a traumatic birth experience. As PDPH is unexpected and can cause severe maternal sequele, PDPH can exhibit a posttraumatic stress response. Therefore we hypothesize that parturients who suffered from a PDPH are at higher risk for developing PP-PTSD.
To date, very few reports have examined the long term outcomes of parturients suffering from a PDPH. As a follow up to the national survey of PDPH management in Israel the investigators aim, in this prospective multi center, observational study, to evaluate the long term outcomes of parturients suffering from a PDPH, including chronic headache, backache, postpartum depression, decreased breastfeeding and the development of PP PTSD.
Detailed description
Introduction:
Epidural analgesia is considered a gold standard method for treatment of labor pain . However one of the major risks with epidural analgesia is an accidental dural puncture, a common complication occurring in 0.4-6% of the obstetric population . ADP increases the risk of developing a post dural puncture headache (PDPH) in 50% of parturients. PDPH is defined as a postural headache that worsens within fifteen minutes of standing and is relieved in the supine position . PDPH results from a CSF leakage from the intrathecal space, causing a decrease in CSF volume and pressure .
PDPH is associated with significant maternal morbidity, prolonging hospital stay, preventing ambulation and impairing maternal neonatal bonding . Less frequently PDPH can cause severe maternal complications resulting in posterior reversible encephalopathic syndrome , pneumocephalus , or a subdural hematoma .
Treatment protocols for PDPH vary greatly, with numerous existing conservative/ invasive treatment options . Conservative treatment includes bed rest, fluids administration, non-steroidal anti-inflammatory drugs and caffeine intake. The most standard invasive method for treatment of PDPH with a reported success rate of 70-90% includes the epidural blood patch (EPD) which is applied by injecting autologous blood epidurally .
Several factors have been found to increase the risk for developing a PDPH and increasing the duration of a PDPH including young age, low BMI and previous history of anxiety or depression .
Posttraumatic stress disorder is classified as an anxiety syndrome one may develop in response to a traumatic experience. Clinical manifestations include persistent re-experience, avoidance of traumatic memories, hyperarousal and emotional numbing . In a retrospective analysis war related PTSD was not associated with increased risk of PDPH.
Post partum (PP) PTSD is a form of PTSD occurring in the postpartum period in relation to a traumatic birth . As PDPH is unexpected and can cause severe maternal sequele, PDPH can exhibit a posttraumatic stress response. Therefore the investigators hypothesize that parturients who suffered from a PDPH are at higher risk for developing PP-PTSD.
To date very few reports have examined the long term outcomes of parturients suffering from a PDPH associated with epidural analgesia. In a prospective, case control trial Webb et al demonstrated an increased risk for developing a chronic headache and backache in 40 parturients who suffered an accidental dural puncture with a large gauge needle . In a five year follow-up study examining long term consequences of PDPH, PDPH was associated with persistent headache and backache in the obstetric population. In a case control trial evaluating long term auditory function following EBP treatment for PDPH, a minor hearing loss was detected in the PDPH group . However, these studies had a small sample size.
As a follow up to the national survey of PDPH management in Israel the investigators aimed in this study to evaluate the long term consequences of PDPH including chronic headache, backache, postpartum depression (PPD), decreased breastfeeding and the development of PP PTSD.
Study Objective:
In this study the investigators intend to evaluate the long term sequelae of parturients who suffered from an accidental dural puncture and a subsequent PDPH.
Primary Aims:
This study's primary objective is to examine whether parturients suffering from a PDPH are at higher risk long-term for developing PP-PTSD than their counterparts.
Secondary aims:
Secondary aims include long term outcomes of parturients who suffered from PDPH:
- Chronic headache
- Chronic backache
- Comparing long term outcomes of parturients suffering from a PDPH with conservative treatment verses epidural blood patch treatment.
- PPD
- Breastfeeding outcomes including duration of breastfeeding
- Women will also be questioned about other labor experiences including analgesic consumption, breastfeeding outcome.
Study Design This study is a prospective multi center cohort, study. Following obtaining approval from the local Institutional Review Board at each center, all women who developed a PDPH following an ADP between the years 2007-2017 will be contacted by phone and verbal consent will be obtained for participation in the study. Each participant will be compared to two women receiving epidural analgesia on the same day as those women who suffered an ADP. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS)translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire . Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire . Parturients will also be asked about other labor experiences including analgesic consumption and breastfeeding outcome, in cases of breastfeeding cessation women will be asked an open-ended question about the reason for discontinuation.
Data collection:
Additional data will be collected from an electronic medical file database. Data collection will include; parturient's demographic data, obstetric data, in case of EBP treatment procedural data (level of injection, volume of blood injected, loss of resistance technique- air/saline, anesthesiologist experience, time of procedure, duration of procedure, technical difficulties, visual analogue score (VAS) upon lying down/ upon sitting up - before the EBP and upon release
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parturients suffering from a PDPH | – | Other: QuestionairesParturients suffering form a PDPH following an accidental dural puncture between the years 2007-2017 will be contacted by phone and verbal consent will be obtained for participation in the study. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire.Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire |
| Parturients not suffering from a PDPH | – | Other: QuestionairesThis group will consistent of a control group of women receiving epidural analgesia on the same day as those women who suffered an ADP. This participants will be contacted by phone and verbal consent will be obtained for participation in the study. All participants will be requested to answer an IRB approved telephone script. Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire.Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All women who developed a PDPH following an ADP between the years 2007-2017 at rabin medical center and at Assaf Harofeh Medical Center.
Key inclusion criteria (1 listed)
- All cases of parturients suffering from a PDPH during the years 2007-2017.
Key exclusion criteria (1 listed)
- Women unable to be answer a questionnaire in Hebrew. Women under the age 18 Women suffering from a PDPH following spinal anesthesia for cesarean section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionairesParturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS)translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire . Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire . | Other | Parturients not suffering from a PDPH, Parturients suffering from a PDPH |
Primary outcome
Post Traumatic Stress Disorder (PTSD) questionnaire score
Time frame: Up to ten years postpartum (Answer at telephone survey)
The total PTSD questionnaire score using the validated PTSD questionnaire
3 secondary outcomes
The total Edinburgh Postnatal Depression Scale (EPDS) questionnaire score
Time frame: Up to ten years postpartum (Answer at telephone survey)
The total score on the Brief Pain Inventory questionnaire
Time frame: Up to ten years postpartum (Answer at telephone survey)
The total score on the Oswestry low back pain questionnaire
Time frame: Up to ten years postpartum (Answer at telephone survey)
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 24 Sep 2019.
- Background: PubMed 23278515Bradbury CL, Singh SI, Badder SR, Wakely LJ, Jones PM. Prevention of post-dural puncture headache in parturients: a systematic review and meta-analysis. Acta Anaesthesiol Scand. 2013 Apr;57(4):417-30. doi: 10.1111/aas.12047. Epub 2012 Dec 28.
- Background: PubMed 25146108Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.
- Background: PubMed 26950232Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
- Background: PubMed 15814755Angle P, Tang SL, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397-402. doi: 10.1007/BF03016283.
- Background: PubMed 22467897Webb CA, Weyker PD, Zhang L, Stanley S, Coyle DT, Tang T, Smiley RM, Flood P. Unintentional dural puncture with a Tuohy needle increases risk of chronic headache. Anesth Analg. 2012 Jul;115(1):124-32. doi: 10.1213/ANE.0b013e3182501c06. Epub 2012 Mar 30.
- Background: PubMed 24600245Shah R, Kubisz-Pudelko A, Reid J. Posterior reversible encephalopathy syndrome following an inadvertent dural puncture during an emergency laparotomy for ischemic colitis - a case report. Local Reg Anesth. 2014 Jan 20;7:1-4. doi: 10.2147/LRA.S57660. eCollection 2014.
- Background: PubMed 22692380Gomez-Rios MA, Fernandez-Goti MC. Pneumocephalus after inadvertent dural puncture during epidural anesthesia. Anesthesiology. 2013 Feb;118(2):444. doi: 10.1097/ALN.0b013e31825e6ecc. No abstract available.
- Background: PubMed 22215524Liang MY, Pagel PS. Bilateral interhemispheric subdural hematoma after inadvertent lumbar puncture in a parturient. Can J Anaesth. 2012 Apr;59(4):389-93. doi: 10.1007/s12630-011-9664-6. Epub 2012 Jan 4.
- Background: PubMed 23450533Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.
- Background: PubMed 22099135Stannard D. Epidural blood patching for preventing and treating postdural puncture headache. J Perianesth Nurs. 2011 Dec;26(6):411-2. doi: 10.1016/j.jopan.2011.09.002. No abstract available.
- Derived from this study: PubMed 32858584Orbach-Zinger S, Eidelman LA, Livne MY, Matkovski O, Mangoubi E, Borovich A, Wazwaz SA, Ioscovich A, Zekry ZHB, Ariche K, Weiniger CF. Long-term psychological and physical outcomes of women after postdural puncture headache: A retrospective, cohort study. Eur J Anaesthesiol. 2021 Feb 1;38(2):130-137. doi: 10.1097/EJA.0000000000001297.
- Individual participant dataSharing planned: No
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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.
Sharon O Zinger principal investigator
Rabin Medical Center
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 Post-Dural Puncture Headache, run by Rabin Medical Center at 2 sites in Israel.
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 24 Sep 2019. 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 Israel. 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 Traumatic Stress Disorder (PTSD) questionnaire score (time frame: Up to ten years postpartum (Answer at telephone survey)). 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 NCT03550586, which also lists 11 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 24 Sep 2019.