Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Po… (NCT02813655) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
Stopped: Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)
France46 participantsStarted 2016-10
Plain-language summary
The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in the treatment of post-dural puncture syndrome in patients receiving epidural analgesia, spinal analgesia, or combined spinal-epidural analgesia for labour.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All women who received epidural, spinal, or combined spinal-epidural labour analgesia and presenting post-dural puncture headache:
* Intense: with ≥3 / 10 numerical rating pain scale
* Appearing within 5 days after delivery
* Aggravating in sitting or standing position and / or improving supine
* Can be associated with one of the following criteria: tinnitus, nausea, photophobia, neck stiffness or pain, hearing loss
* After exclusion of clinically differential diagnoses (preeclampsia or eclampsia, cerebral venous thrombosis, migraine)
* Age greater than or equal to 18 years
* Affiliation to social security scheme
* Inform Consent signed after oral and written information
Exclusion Criteria:
* Presence of diplopia (indication of immediate blood patch)
* Contraindication to ACTH or Synacthène® (unbalanced hypertension, uncontrolled diabetes, uncontrolled psychosis, infectious viral disease state or evolving)
* Processing of Torsade de Pointe provider (astenizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine)
* Live vaccine in the months prior to inclusion
* Hypersensitivity to Synacthène®
* Patient who have previously received Synacthène® after delivery
* Contraindication to blood patch (fever or leukocytosis, HIV or HCV patient)
* Eclampsia or preeclampsia during this pregnancy
* Patient who have received prophylactic blood patch (at diagnosis of Accidental Dural Puncture)
* Minor under 18 or pro…