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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel2 sites
  • Dr. Chatuib Zoya

    Be’er Ya‘aqov

  • Beilinson hospital

    Petach Tikvah

Other trials in Israel

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

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 groups in NCT03550586
Study groupRoleWhat they receive
Parturients suffering from a PDPHParturients 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 PDPHThis 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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.

  1. First posted8 Jun 2018
  2. Study start24 Apr 2018
  3. Primary completion1 Mar 2019
  4. Study completion1 Mar 2019

Resources

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)
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 23278515
  • Sachs 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 25146108
  • Arevalo-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 26950232
  • Angle 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 15814755
  • Webb 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 22467897
  • Shah 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 24600245
  • Gomez-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 22692380
  • Liang 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 22215524
  • Basurto 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 23450533
  • Stannard 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 22099135
  • Orbach-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

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.

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