Blood PatchCHROBLOODNCT05888324
Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum
An observational study of Blood Patch and Post-Dural Puncture Headache, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Blood Patch, Post-Dural Puncture Headache
- What is being tested?
- Questionnaires
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2023to 10 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward
Who may be able to join
- 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,
Who cannot join
- Patient under curatorship or guardianship
- Not speaking/understanding French
- BP performed in another indication
- Benefiting from the AME (state medical aid)
Trial locations and contacts
1 site in 1 country.
France1 site
Port-Royal Maternity ward - Cochin Hopsital - APHP
Paris, Île-de-France Region, 75014
About this study
Official 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
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.
- Conditions
- Blood Patch, Post-Dural Puncture Headache
- Being tested
- Questionnaires
- Keywords
- Post Dural puncture headache, Epidural blood patch, Chronic headache, Epidural analgesia, Obstetric anaesthesia
- Medical subject headings
- Post-Dural Puncture Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires by phone at 1 and 6 months after inclusion
| Study group | Role | What they receive |
|---|---|---|
| Patients with PDPH after epidural analgesia for labor, requiring BP | Patients with PDPH after epidural analgesia for labor, requiring BP Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after BloodPatch procedure
Time to onset
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Measured: Immediately after BloodPatch procedure
Positional
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Measured: Immediately after BloodPatch procedure
Neck pain
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Measured: Immediately after BloodPatch procedure
Analog visual scale (AVS)
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Measured: Immediately after BloodPatch procedure
Neurosensory disorders
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Measured: Immediately after BloodPatch procedure
Completion time after childbirth
Description of the methods of carrying out the BloodPatch (BP)
Measured: Immediately after BloodPatch procedure
Volume injected
Description of the methods of carrying out the BloodPatch (BP)
Measured: Immediately after BloodPatch procedure
Height of puncture compared to the initial breach
Description of the methods of carrying out the BloodPatch (BP)
Measured: Immediately after BloodPatch procedure
Paresthesias
Description of the methods of carrying out the BloodPatch (BP)
Measured: Immediately after BloodPatch procedure
Adverse events
Description of the methods of carrying out the BloodPatch (BP)
Measured: Immediately after BloodPatch procedure
Duration of strict decubitus in the immediate afterglow
Description of the methods of carrying out the BloodPatch (BP)
Measured: Immediately after BloodPatch procedure
Age
Patient data collection
Measured: Immediately after BloodPatch procedure
Height
Patient data collection
Measured: Immediately after BloodPatch procedure
Weight
Patient data collection
Measured: Immediately after BloodPatch procedure
Parity
Patient data collection
Measured: Immediately after BloodPatch procedure
Mode of delivery
Patient data collection
Measured: Immediately after BloodPatch procedure
History of headaches or migraines before pregnancy
Patient data collection
Measured: Immediately after BloodPatch procedure
Initial treatment (before 1st BP)
Patient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other
Measured: Immediately after BloodPatch procedure
Imaging
Patient data collection
Measured: 1 month after last BloodPatch procedure
Lumbar punction
Patient data collection
Measured: 1 month after last BloodPatch procedure
Other examinations if performed
Patient data collection
Measured: 1 month after last BloodPatch procedure
Complications during the initial postpartum stay
Patient data collection
Measured: Immediately after BloodPatch procedure
Analog visual scale (AVS)
Patient data collection - Initial efficacy
Measured: Immediately after BloodPatch procedure
Analog visual scale (AVS)
Patient data collection - Initial efficacy
Measured: 1 day after BloodPatch procedure
Analog visual scale (AVS)
Patient data collection - Initial efficacy
Measured: At exit of the hospital, up to 2 weeks
Secondary outcomes (16)
Number of patients with chronic headaches
Score - phone questionnaire
Measured: Month 1
Number of patients with chronic headaches
Score - phone questionnaire
Measured: Month 6
Number of patients with chronic low back pain
Score - phone questionnaire
Measured: Month 1
Number of patients with chronic low back pain
Score - phone questionnaire
Measured: Month 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"
Measured: Month 1
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"
Measured: Month 6
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)
Score - phone questionnaire
Measured: Month 1
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)
Score - phone questionnaire
Measured: Month 6
Number of patients who have been rehospitalized
Score - phone questionnaire
Measured: Month 1
Number of patients who have been rehospitalized
Score - phone questionnaire
Measured: Month 6
Number of patients consulted for headaches
Score - phone questionnaire
Measured: Month 1
Number of patients consulted for headaches
Score - phone questionnaire
Measured: Month 6
Number of patients who received complementary treatments
Score - phone questionnaire
Measured: Month 1
Number of patients who received complementary treatments
Score - phone questionnaire
Measured: Month 6
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
Measured: Month 1
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
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start6 Jun 2023
- Primary completion23 Apr 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PatchStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Catherine FISCHER, MD, Principal investigator, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888324
- Sponsor's protocol ID
- APHP220572
- Other IDs
- 022-A00933-40
- Acronym
- CHROBLOOD
- Status last verified
- May 2026
- First submitted
- 14 Nov 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05888324
- Acronym / sponsor ID
- CHROBLOOD / APHP220572
- Conditions
- Blood Patch, Post-Dural Puncture Headache
- Keywords
- Post Dural puncture headache, Epidural blood patch, Chronic headache, Epidural analgesia, Obstetric anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PDPH after epidural analgesia for labor, requiring BP | – | Other: QuestionnairesPatients with PDPH after epidural analgesia for labor, requiring BP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (4 listed)
- Patient under curatorship or guardianship
- Not speaking/understanding French
- BP performed in another indication
- Benefiting from the AME (state medical aid)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires by phone at 1 and 6 months after inclusion | Other | Patients with PDPH after epidural analgesia for labor, requiring BP |
Primary outcome
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
Time to onset
Time frame: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Positional
Time frame: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Neck pain
Time frame: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
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
Neurosensory disorders
Time frame: Immediately after BloodPatch procedure
Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH
Completion time after childbirth
Time frame: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Volume injected
Time frame: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Height of puncture compared to the initial breach
Time frame: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Paresthesias
Time frame: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Adverse events
Time frame: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Duration of strict decubitus in the immediate afterglow
Time frame: Immediately after BloodPatch procedure
Description of the methods of carrying out the BloodPatch (BP)
Age
Time frame: Immediately after BloodPatch procedure
Patient data collection
Height
Time frame: Immediately after BloodPatch procedure
Patient data collection
Weight
Time frame: Immediately after BloodPatch procedure
Patient data collection
Parity
Time frame: Immediately after BloodPatch procedure
Patient data collection
Mode of delivery
Time frame: Immediately after BloodPatch procedure
Patient data collection
History of headaches or migraines before pregnancy
Time frame: Immediately after BloodPatch procedure
Patient data collection
Initial treatment (before 1st BP)
Time frame: Immediately after BloodPatch procedure
Patient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other
Imaging
Time frame: 1 month after last BloodPatch procedure
Patient data collection
Lumbar punction
Time frame: 1 month after last BloodPatch procedure
Patient data collection
Other examinations if performed
Time frame: 1 month after last BloodPatch procedure
Patient data collection
Complications during the initial postpartum stay
Time frame: Immediately after BloodPatch procedure
Patient data collection
Analog visual scale (AVS)
Time frame: Immediately after BloodPatch procedure
Patient data collection - Initial efficacy
Analog visual scale (AVS)
Time frame: 1 day after BloodPatch procedure
Patient data collection - Initial efficacy
Analog visual scale (AVS)
Time frame: At exit of the hospital, up to 2 weeks
Patient data collection - Initial efficacy
16 secondary outcomes
Number of patients with chronic headaches
Time frame: Month 1
Number of patients with chronic headaches
Time frame: Month 6
Number of patients with chronic low back pain
Time frame: Month 1
Number of patients with chronic low back pain
Time frame: Month 6
Modified Headache Impact Questionnaire (HIT)
Time frame: Month 1
Modified Headache Impact Questionnaire (HIT)
Time frame: Month 6
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)
Time frame: Month 1
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)
Time frame: Month 6
Number of patients who have been rehospitalized
Time frame: Month 1
Number of patients who have been rehospitalized
Time frame: Month 6
Number of patients consulted for headaches
Time frame: Month 1
Number of patients consulted for headaches
Time frame: Month 6
Number of patients who received complementary treatments
Time frame: Month 1
Number of patients who received complementary treatments
Time frame: Month 6
Patient data collection
Time frame: Month 1
Patient data collection
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine FISCHER, MD principal investigator
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Patch and Post-Dural Puncture Headache, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the conditions of the accidental breach (time frame: Immediately after BloodPatch procedure). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.