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Study · Randomized controlled trial · n = 44 · 2025

7 results

No effect of tetracosactide for treatment of postdural puncture headaches in parturient women: a double-blind randomised controlled clinical trial.

Dziadzko M, Bouvet L, Steer N, Depaulis C, Pradat P, Joubert F, Lalande L, Chassard D, Aubrun F

British journal of anaesthesia19 May 2025Cited by 2 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    At interim analysis in postpartum patients with PDPH, epidural blood patch rates did not differ significantly: 21 (91%) after tetracosactide versus 18 (86%) after placebo (P=0.6575).

    In plain wordsAt an interim check in postpartum patients with PDPH, tetracosactide did not significantly change blood patch use compared with placebo.

    Outcome
    No significant changeEpidural blood patch within 15 days
    Study

    n = 44

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    1 mg · intravenous · single doseAs given in this study (human).

    Measurements

    Patients receiving epidural blood patch
    21 patients
    tetracosactide group
    Epidural blood patch rate
    91%
    tetracosactide group
    Patients receiving epidural blood patch
    18 patients
    placebo group
    Epidural blood patch rate
    86%
    placebo group

    Source sentences

    Summary
    At interim analysis with 44 patients enrolled (23 in the treatment group and 21 in the placebo group) no significant difference was found for the primary outcome: 21 (91%) patients in the treatment group and 18 (86%) patients in the placebo group received EBP (P=0.6575).
    3 context sentences
    Summary · context
    The primary outcome was the rate of EBP within the 15-day follow-up.
    Summary · context
    A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals.
    Summary · context
    Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postpartum patients with PDPH, headache duration was comparable with tetracosactide and placebo.

    In plain wordsIn postpartum patients with PDPH, headache duration was comparable with tetracosactide and placebo.

    Outcome
    No significant changeHeadache duration
    Study

    n = 44

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    1 mg · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    Secondary outcomes were comparable between groups, except for a 1-day longer hospital stay in the treatment group (P=0.0486).
    3 context sentences
    Summary · context
    Secondary outcomes included headache duration and intensity, activity limitation, length of hospital stay, and the number of EBPs performed per patient.
    Summary · context
    A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals.
    Summary · context
    Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postpartum patients with PDPH, headache intensity was comparable with tetracosactide and placebo.

    In plain wordsIn postpartum patients with PDPH, headache intensity was comparable with tetracosactide and placebo.

    Outcome
    No significant changeHeadache intensity
    Study

    n = 44

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    1 mg · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    Secondary outcomes were comparable between groups, except for a 1-day longer hospital stay in the treatment group (P=0.0486).
    3 context sentences
    Summary · context
    Secondary outcomes included headache duration and intensity, activity limitation, length of hospital stay, and the number of EBPs performed per patient.
    Summary · context
    A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals.
    Summary · context
    Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postpartum patients with PDPH, activity limitation was comparable with tetracosactide and placebo.

    In plain wordsIn postpartum patients with PDPH, activity limitation was comparable with tetracosactide and placebo.

    Outcome
    No significant changeActivity limitation
    Study

    n = 44

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    1 mg · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    Secondary outcomes were comparable between groups, except for a 1-day longer hospital stay in the treatment group (P=0.0486).
    3 context sentences
    Summary · context
    Secondary outcomes included headache duration and intensity, activity limitation, length of hospital stay, and the number of EBPs performed per patient.
    Summary · context
    A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals.
    Summary · context
    Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postpartum patients with PDPH, hospital stay was 1 day longer after tetracosactide than placebo (P=0.0486).

    In plain wordsIn postpartum patients with PDPH, hospital stay was 1 day longer after tetracosactide than placebo.

    Outcome
    IncreaseHospital stay
    Study

    n = 44

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Intensive care and hospital outcomes · Whole body
    Studied dose
    1 mg · intravenous · single doseAs given in this study (human).

    Measurements

    Hospital stay difference
    1 day
    longer in tetracosactide group than placebo

    Source sentences

    Summary
    Secondary outcomes were comparable between groups, except for a 1-day longer hospital stay in the treatment group (P=0.0486).
    3 context sentences
    Summary · context
    Secondary outcomes included headache duration and intensity, activity limitation, length of hospital stay, and the number of EBPs performed per patient.
    Summary · context
    A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals.
    Summary · context
    Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postpartum patients with PDPH, blood patches per patient were comparable with tetracosactide and placebo.

    In plain wordsIn postpartum patients with PDPH, blood patches per patient were comparable with tetracosactide and placebo.

    Outcome
    No significant changeBlood patches per patient
    Study

    n = 44

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Pain · Nervous system and cognition
    Studied dose
    1 mg · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    Secondary outcomes were comparable between groups, except for a 1-day longer hospital stay in the treatment group (P=0.0486).
    3 context sentences
    Summary · context
    Secondary outcomes included headache duration and intensity, activity limitation, length of hospital stay, and the number of EBPs performed per patient.
    Summary · context
    A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals.
    Summary · context
    Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo.
  7. 07HumanNon-randomized trialSafety outcome

    In postpartum patients with PDPH, no side effects of tetracosactide were observed.

    In plain wordsIn postpartum patients with PDPH, no side effects of tetracosactide were observed.

    Outcome
    Not applicableSide effects
    Study

    n = 23

    Outcome group
    Adverse events · Whole body
    Studied dose
    1 mg · intravenous · single doseAs given in this study (human).

    Source sentences

    Summary
    No side-effects of tetracosactide administration were observed.
    2 context sentences
    Summary · context
    A randomised, double-blind, placebo-controlled trial was conducted in two tertiary care maternal hospitals.
    Summary · context
    Postpartum patients with PDPH after neuraxial anaesthesia were randomised to receive either tetracosactide 1 mg i.v. or placebo.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 stopped early · source ClinicalTrials.gov (opens in a new tab)

TerminatedPhase 2NCT02813655

Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)

Hospices Civils de Lyonn = 46Oct 2016 to 21 Nov 2022

Post-dural Puncture Headache

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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