Investigating chronic headaches after blood patch treatment in postpartum patients
Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch, Following an Accidental Dural Puncture During Post Partum Period
Assistance Publique - Hôpitaux de Paris · NCT05888324
This study is trying to find out what might cause chronic headaches in new mothers who had a blood patch treatment for headaches after childbirth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, Ile De France) |
| Trial ID | NCT05888324 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify risk factors associated with the onset of chronic headaches in patients who received a blood patch to treat post-dural puncture headaches during the early postpartum period. Researchers will analyze various factors, including the conditions surrounding the accidental dural puncture, the initial symptoms of the headache, and the methods used for the blood patch procedure. Participants will be evaluated through phone questionnaires to assess the incidence of chronic headaches, low back pain, and any complications at 1 and 6 months post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone vaginal delivery or caesarean section with epidural anesthesia at the Port Royal maternity ward.
Not a fit: Patients who do not speak or understand French or those who had a blood patch performed for indications other than post-dural puncture headache may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify risk factors that may prevent chronic headaches in postpartum patients after a blood patch procedure.
How similar studies have performed: While the association between blood patches and chronic headaches has been noted, this specific investigation into risk factors is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than or equal to 18 years old, * Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward, * Collection of non-opposition after oral and written information, Exclusion Criteria: * Patient under curatorship or guardianship * Not speaking/understanding French * BP performed in another indication * Benefiting from the AME (state medical aid)
Where this trial is running
Paris, Ile De France
- Port-Royal Maternity ward - Cochin Hopsital - APHP — Paris, Ile De France, France (RECRUITING)
Study contacts
- Principal investigator: Catherine FISCHER, MD — Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
- Study coordinator: Catherine FISCHER, MD
- Email: catherine.fischer2@aphp.fr
- Phone: 00 33 1 58 41 39 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Patch, Post-Dural Puncture Headache, Post Dural puncture headache, Epidural blood patch, Chronic headache, Epidural analgesia, Obstetric anaesthesia