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Long Term Outcomes Following a Post Dural Puncture Headache

NCT03550586 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2019-09-24

No results posted yet for this study

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. 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.

Conditions

  • Post-Dural Puncture Headache

Interventions

OTHER

Questionaires

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 .

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    collaborator OTHER_GOV

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Sharon O Zinger · Rabin Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550586 on ClinicalTrials.gov