No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial
- Interim futility analysis planned at 50% enrolment; trial terminated for futility
Authors' conclusion
A single dose of tetracosactide did not demonstrate efficacy in preventing EBP needs in postpartum PDPH, and there was no effect on the intensity, duration of headaches, and physical activity limitations.
Study context
- Population
- Postpartum patients with postdural puncture headache (PDPH) after neuraxial anaesthesia, two tertiary care maternal hospitalsenrolled at interim analysis
- Participants
- 44 patients
- Comparison
- Tetracosactide 1 mg i.v. vs placebo
- Tetracosactiden = 23
- Placebon = 21reference
- Primary endpoint
- Rate of epidural blood patch (EBP)
- Follow-up
- within the 15-day follow-up
Methodological detailsdouble-blind, placebo-controlled, two-centre, prespecified interim futility analysis
- Double-blind
- Placebo-controlled
- Two-centre
- Prespecified interim futility analysis
Primary result
As reported in the abstract
P = 0.6575
Secondary outcomes
| Outcome | Difference (day) | P value |
|---|---|---|
| Hospital LOSLonger in the tetracosactide group · interim analysis | 1 | P = 0.0486 |
Headache duration and intensity, activity limitation, number of epidural blood patch (EBPs) per patient
- Comparable between groups
- Interim analysis
Safety
Side-effects of tetracosactide
- No side-effects observed
Original publication
No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial. Br J Anaesth. Published 19 May 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →