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CompletedNCT05888324CHROBLOODUpdated May 28, 2026

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

An observational study in Blood Patch and Post-Dural Puncture Headache, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
98
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Blood Patch
  • Post-Dural Puncture Headache

Keywords

  • Post Dural puncture headache
  • Epidural blood patch
  • Chronic headache
  • Epidural analgesia
  • Obstetric anaesthesia
03

In context

Post-Dural Puncture Headache

122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.

This study's enrollment of 98 is below the median of 150 across 35 observational studies indexed under Post-Dural Puncture Headache.

Browse Post-Dural Puncture Headache studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient under curatorship or guardianship
  • Not speaking/understanding French
  • BP performed in another indication
  • Benefiting from the AME (state medical aid)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
98 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with PDPH after epidural analgesia for labor, requiring BP

    Patients with PDPH after epidural analgesia for labor, requiring BP

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

    Questionnaires by phone at 1 and 6 months after inclusion

06

What researchers measure

Primary outcomes

  1. Description of the conditions of the accidental breach

    Data collection of diagnosis of the accidental breach : * noted with the needle, * intrathecal passage, * postpartum positional headaches, * intrathecal catheter

    Time frame: Immediately after BloodPatch procedure

  2. Time to onset

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

    Time frame: Immediately after BloodPatch procedure

  3. Positional

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

    Time frame: Immediately after BloodPatch procedure

  4. Neck pain

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

    Time frame: Immediately after BloodPatch procedure

  5. Analog visual scale (AVS)

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

    Time frame: Immediately after BloodPatch procedure

  6. Neurosensory disorders

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

    Time frame: Immediately after BloodPatch procedure

  7. Completion time after childbirth

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

    Time frame: Immediately after BloodPatch procedure

  8. Volume injected

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

    Time frame: Immediately after BloodPatch procedure

  9. Height of puncture compared to the initial breach

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

    Time frame: Immediately after BloodPatch procedure

  10. Paresthesias

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

    Time frame: Immediately after BloodPatch procedure

  11. Adverse events

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

    Time frame: Immediately after BloodPatch procedure

  12. Duration of strict decubitus in the immediate afterglow

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

    Time frame: Immediately after BloodPatch procedure

  13. Age

    Patient data collection

    Time frame: Immediately after BloodPatch procedure

  14. Height

    Patient data collection

    Time frame: Immediately after BloodPatch procedure

  15. Weight

    Patient data collection

    Time frame: Immediately after BloodPatch procedure

  16. Parity

    Patient data collection

    Time frame: Immediately after BloodPatch procedure

  17. Mode of delivery

    Patient data collection

    Time frame: Immediately after BloodPatch procedure

  18. History of headaches or migraines before pregnancy

    Patient data collection

    Time frame: Immediately after BloodPatch procedure

  19. Initial treatment (before 1st BP)

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

    Time frame: Immediately after BloodPatch procedure

  20. Imaging

    Patient data collection

    Time frame: 1 month after last BloodPatch procedure

  21. Lumbar punction

    Patient data collection

    Time frame: 1 month after last BloodPatch procedure

  22. Other examinations if performed

    Patient data collection

    Time frame: 1 month after last BloodPatch procedure

  23. Complications during the initial postpartum stay

    Patient data collection

    Time frame: Immediately after BloodPatch procedure

  24. Analog visual scale (AVS)

    Patient data collection - Initial efficacy

    Time frame: Immediately after BloodPatch procedure

  25. Analog visual scale (AVS)

    Patient data collection - Initial efficacy

    Time frame: 1 day after BloodPatch procedure

  26. Analog visual scale (AVS)

    Patient data collection - Initial efficacy

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

Secondary outcomes

  1. Number of patients with chronic headaches

    Score - phone questionnaire

    Time frame: Month 1

  2. Number of patients with chronic headaches

    Score - phone questionnaire

    Time frame: Month 6

  3. Number of patients with chronic low back pain

    Score - phone questionnaire

    Time frame: Month 1

  4. Number of patients with chronic low back pain

    Score - phone questionnaire

    Time frame: Month 6

  5. Modified Headache Impact Questionnaire (HIT)

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

    Time frame: Month 1

  6. Modified Headache Impact Questionnaire (HIT)

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

    Time frame: Month 6

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

    Score - phone questionnaire

    Time frame: Month 1

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

    Score - phone questionnaire

    Time frame: Month 6

  9. Number of patients who have been rehospitalized

    Score - phone questionnaire

    Time frame: Month 1

  10. Number of patients who have been rehospitalized

    Score - phone questionnaire

    Time frame: Month 6

  11. Number of patients consulted for headaches

    Score - phone questionnaire

    Time frame: Month 1

  12. Number of patients consulted for headaches

    Score - phone questionnaire

    Time frame: Month 6

  13. Number of patients who received complementary treatments

    Score - phone questionnaire

    Time frame: Month 1

  14. Number of patients who received complementary treatments

    Score - phone questionnaire

    Time frame: Month 6

  15. Patient data collection

    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

    Time frame: Month 1

  16. Patient data collection

    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

    Time frame: Month 6

07

Study locations

1 site
  • Port-Royal Maternity ward - Cochin Hopsital - APHP
    Paris, Île-de-France Region 75014, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Apr 2025, 22 months.

Of 18 observational studies under Post-Dural Puncture Headache, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 22 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2022
First posted
Jun 5, 2023
StartActual
Jun 6, 2023
Primary completionActual
Apr 23, 2025
CompletionActual
Jun 10, 2025
Last update
May 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05888324
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
Jun 6, 2023
Primary completion
Apr 23, 2025
Completion
Jun 10, 2025
Last update
May 28, 2026

Study contacts

Catherine FISCHER, MD
principal investigator · Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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