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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003357-17 | EudraCT Number |
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Interim analysis and decision of the independent committee, investigators and sponsor (futility) (2023/10/05)
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Tetracosactide (Synacthène®) |
|
| Control arm | Placebo Comparator | placebo saline (0.9% NaCl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetracosactide (Synacthène®) | Drug | Tetracosactide, manufactured by Sigma-Tau® laboratories and marketed under the name of Synacthène®. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 1 mg of Synacthène® intravenously during 20 minutes. Four vials of 1 ml of Synacthène® will be added to a bag of 100 ml of physiological saline. The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of blood patch use | Assessment of the rate of blood patch use between experimental group (Synacthène®) and control group between day 0 and day 15. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Type, severity and number of side effects in each group (control and experimental) between day 0 and day 15 | Day 15 |
| Duration of headache | Duration of headache in each group (control and experimental) between day 0 and day 15 |
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Inclusion Criteria:
All women who received epidural, spinal, or combined spinal-epidural labour analgesia and presenting post-dural puncture headache:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Bron | France | ||||
| Hospices Civils de Lyon / hôpital de la Croix rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40393818 | Result | Dziadzko M, Bouvet L, Steer N, Depaulis C, Pradat P, Joubert F, Lalande L, Chassard D, Aubrun F. No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial. Br J Anaesth. 2025 Jul;135(1):148-154. doi: 10.1016/j.bja.2025.04.012. Epub 2025 May 19. | |
| 31915040 |
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|
| placebo saline (0.9% NaCl) | Drug | placebo saline manufactured by the laboratory Aguettant: 10ml vial, 4 mL will be collected and added to a bag of 100 ml of saline. All women who received epidural or combined spinal-epidural labour analgesia and presenting post-partum post dural puncture headache were randomized. The patient will receive 4 ml of placebo saline added to a bag of 100 ml of physiological saline ( 104 ml of physiological saline). The injection of study treatment must be done within 6 hours after the inclusion. Monitoring of the patient is carried out throughout the duration of administration of the drug, then between H2 and H6, D1, D2, D3 and D15. |
|
| Day 15 |
| Intensity of headache | Intensity of headache in each group (control and experimental) between day 0 and day 15 | Day 15 |
| analgesic use (type and duration) in each group (control and experimental) | analgesic use (type and duration) in each group (control and experimental) between day 0 and day 15 | Day 15 |
| blood-patch number | blood-patch number per patient in each group (control and experimental) between day 0 and day 15 | Day 15 |
| Time to first analgesic use after injection of treatment (Synacthène® or placebo) | Day 15 |
| Lyon |
| 69004 |
| France |
| Depaulis C, Steer N, Garessus L, Chassard D, Aubrun F. Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial. Trials. 2020 Jan 8;21(1):55. doi: 10.1186/s13063-019-4015-y. |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003366 | Cosyntropin |
| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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