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Completed

NCT Number: NCT05888324

Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum

The purpose of this study is to identify possible links between conditions for carrying out a blood patch (BP) to treat accidental post dural puncture acute headache (PDPH) in the early post partum period and occurrence of chronic headaches at 1 and 6 months.

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Key information

Conditions

Blood Patch Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Dural Puncture Headache

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Port-Royal Maternity ward - Cochin Hopsital - APHP

Paris, Île-de-France Region, 75014, France

About this study

It is established that accidental dural puncture promotes the onset of chronic headaches in 25 to 60% of cases but the risk factors for the occurrence of this event are not known.

To identify those risk factors, the investigators will analyze the initial conditions of the accidental breach, the initial manifestations of the PDPH, the methods of carrying out the BP and the patient data.

In this study, the investigators will evaluate (phone questionnaire and score) incidence of chronic headaches at 1 month and 6 months after the realization of a blood patch, incidence of chronic low back pain, impact on daily life, incidence of late recurrences of PDPH, incidence of early and distant complications

In case of failure of effectiveness of the first blood patch, the investigators will search for associated factors: patient data, mode of delivery, initial PDPH, conditions for carrying out the BP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

questionnaires

Other

Questionnaires by phone at 1 and 6 months after inclusion

Primary outcomes

  1. Description of the conditions of the accidental breach

    Time frame: Immediately after BloodPatch procedure

    Data collection of diagnosis of the accidental breach :

    • noted with the needle,
    • intrathecal passage,
    • postpartum positional headaches,
    • intrathecal catheter

  2. Time to onset

    Time frame: Immediately after BloodPatch procedure

    Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH

  3. Positional

    Time frame: Immediately after BloodPatch procedure

    Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH

  4. Neck pain

    Time frame: Immediately after BloodPatch procedure

    Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH

  5. Analog visual scale (AVS)

    Time frame: Immediately after BloodPatch procedure

    Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH

  6. Neurosensory disorders

    Time frame: Immediately after BloodPatch procedure

    Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH

  7. Completion time after childbirth

    Time frame: Immediately after BloodPatch procedure

    Description of the methods of carrying out the BloodPatch (BP)

  8. Volume injected

    Time frame: Immediately after BloodPatch procedure

    Description of the methods of carrying out the BloodPatch (BP)

  9. Height of puncture compared to the initial breach

    Time frame: Immediately after BloodPatch procedure

    Description of the methods of carrying out the BloodPatch (BP)

  10. Paresthesias

    Time frame: Immediately after BloodPatch procedure

    Description of the methods of carrying out the BloodPatch (BP)

  11. Adverse events

    Time frame: Immediately after BloodPatch procedure

    Description of the methods of carrying out the BloodPatch (BP)

  12. Duration of strict decubitus in the immediate afterglow

    Time frame: Immediately after BloodPatch procedure

    Description of the methods of carrying out the BloodPatch (BP)

  13. Age

    Time frame: Immediately after BloodPatch procedure

    Patient data collection

  14. Height

    Time frame: Immediately after BloodPatch procedure

    Patient data collection

  15. Weight

    Time frame: Immediately after BloodPatch procedure

    Patient data collection

  16. Parity

    Time frame: Immediately after BloodPatch procedure

    Patient data collection

  17. Mode of delivery

    Time frame: Immediately after BloodPatch procedure

    Patient data collection

  18. History of headaches or migraines before pregnancy

    Time frame: Immediately after BloodPatch procedure

    Patient data collection

  19. Initial treatment (before 1st BP)

    Time frame: Immediately after BloodPatch procedure

    Patient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other

  20. Imaging

    Time frame: 1 month after last BloodPatch procedure

    Patient data collection

  21. Lumbar punction

    Time frame: 1 month after last BloodPatch procedure

    Patient data collection

  22. Other examinations if performed

    Time frame: 1 month after last BloodPatch procedure

    Patient data collection

  23. Complications during the initial postpartum stay

    Time frame: Immediately after BloodPatch procedure

    Patient data collection

  24. Analog visual scale (AVS)

    Time frame: Immediately after BloodPatch procedure

    Patient data collection - Initial efficacy

  25. Analog visual scale (AVS)

    Time frame: 1 day after BloodPatch procedure

    Patient data collection - Initial efficacy

  26. Analog visual scale (AVS)

    Time frame: At exit of the hospital, up to 2 weeks

    Patient data collection - Initial efficacy

Secondary outcomes

  1. Number of patients with chronic headaches

    Time frame: Month 1

    Score - phone questionnaire

  2. Number of patients with chronic headaches

    Time frame: Month 6

    Score - phone questionnaire

  3. Number of patients with chronic low back pain

    Time frame: Month 1

    Score - phone questionnaire

  4. Number of patients with chronic low back pain

    Time frame: Month 6

    Score - phone questionnaire

  5. Modified Headache Impact Questionnaire (HIT)

    Time frame: Month 1

    Impact on daily life - Phone questionnaire - Headaches : "Yes/No" Low back pain, "never/rarely/from time to time/often/all the time"

  6. Modified Headache Impact Questionnaire (HIT)

    Time frame: Month 6

    Impact on daily life - Phone questionnaire - Headaches : "Yes/No" Low back pain, "never/rarely/from time to time/often/all the time"

  7. Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)

    Time frame: Month 1

    Score - phone questionnaire

  8. Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)

    Time frame: Month 6

    Score - phone questionnaire

  9. Number of patients who have been rehospitalized

    Time frame: Month 1

    Score - phone questionnaire

  10. Number of patients who have been rehospitalized

    Time frame: Month 6

    Score - phone questionnaire

  11. Number of patients consulted for headaches

    Time frame: Month 1

    Score - phone questionnaire

  12. Number of patients consulted for headaches

    Time frame: Month 6

    Score - phone questionnaire

  13. Number of patients who received complementary treatments

    Time frame: Month 1

    Score - phone questionnaire

  14. Number of patients who received complementary treatments

    Time frame: Month 6

    Score - phone questionnaire

  15. Patient data collection

    Time frame: Month 1

    In case of failure of efficacy of the 1st BP: patient data, mode of delivery, initial Post dural puncture acute headache (PDPH), conditions for carrying out the BP

  16. Patient data collection

    Time frame: Month 6

    In case of failure of efficacy of the 1st BP: patient data, mode of delivery, initial Post dural puncture acute headache (PDPH), conditions for carrying out the BP

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch, Following an Accidental Dural Puncture During Post Partum Period

Acronym: CHROBLOOD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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