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NCT03550586

Long Term Outcomes Following a Post Dural Puncture Headache

Completed Last updated 24 September 2019
What this trial tests

trial testing Questionaires in Post-Dural Puncture Headache in 240 participants. Completed in 1 March 2019.

Timeline
24 April 2018
Primary endpoint
1 March 2019
1 March 2019

Quick facts

Lead sponsorRabin Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment240
Start date24 April 2018
Primary completion1 March 2019
Estimated completion1 March 2019
Sites2 locations across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rabin Medical Center

Who can join

18 and older, female only, with Post-Dural Puncture Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Long-term psychological and physical outcomes of women after postdural puncture headache: A retrospective, cohort study.
    Orbach-Zinger S, Eidelman LA, Livne MY, Matkovski O, et al · · 2021 · cited 33× · PMID 32858584 · DOI 10.1097/eja.0000000000001297

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