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NCT03550586
Long Term Outcomes Following a Post Dural Puncture Headache
trial testing Questionaires in Post-Dural Puncture Headache in 240 participants. Completed in 1 March 2019.
1 March 2019
Quick facts
| Lead sponsor | Rabin Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 240 |
| Start date | 24 April 2018 |
| Primary completion | 1 March 2019 |
| Estimated completion | 1 March 2019 |
| Sites | 2 locations across Israel |
Drugs / interventions tested
- Questionaires
Conditions studied
- Post-Dural Puncture Headache — all drugs for Post-Dural Puncture Headache →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03550586
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03550586 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rabin Medical Center
- Last refreshed: 24 September 2019
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