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

Post-Dural Puncture Headache Clinical Trial

— CHROBLOOD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888324
• Other study ID #: APHP220572
• Secondary ID: 022-A00933-40
• Status: Recruiting
• Start date: June 6, 2023
• Est. completion date: January 2025

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Catherine FISCHER, MD
• Phone: 00 33 1 58 41 39 26
• Email: catherine.fischer2[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: December 6, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Post-Dural Puncture Headache

Intervention

Other:
• Questionnaires
Questionnaires by phone at 1 and 6 months after inclusion

Locations

Country	Name	City	State
France	Port-Royal Maternity ward - Cochin Hopsital - APHP	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediately after BloodPatch procedure
Primary	Time to onset	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Primary	Positional	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Primary	Neck pain	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Primary	Analog visual scale (AVS)	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Primary	Neurosensory disorders	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Primary	Completion time after childbirth	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Primary	Volume injected	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Primary	Height of puncture compared to the initial breach	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Primary	Paresthesias	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Primary	Adverse events	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Primary	Duration of strict decubitus in the immediate afterglow	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Primary	Age	Patient data collection	Immediately after BloodPatch procedure
Primary	Height	Patient data collection	Immediately after BloodPatch procedure
Primary	Weight	Patient data collection	Immediately after BloodPatch procedure
Primary	Parity	Patient data collection	Immediately after BloodPatch procedure
Primary	Mode of delivery	Patient data collection	Immediately after BloodPatch procedure
Primary	History of headaches or migraines before pregnancy	Patient data collection	Immediately after BloodPatch procedure
Primary	Initial treatment (before 1st BP)	Patient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other	Immediately after BloodPatch procedure
Primary	Imaging	Patient data collection	1 month after last BloodPatch procedure
Primary	Lumbar punction	Patient data collection	1 month after last BloodPatch procedure
Primary	Other examinations if performed	Patient data collection	1 month after last BloodPatch procedure
Primary	Complications during the initial postpartum stay	Patient data collection	Immediately after BloodPatch procedure
Primary	Analog visual scale (AVS)	Patient data collection - Initial efficacy	Immediately after BloodPatch procedure
Primary	Analog visual scale (AVS)	Patient data collection - Initial efficacy	1 day after BloodPatch procedure
Primary	Analog visual scale (AVS)	Patient data collection - Initial efficacy	At exit of the hospital, up to 2 weeks
Secondary	Number of patients with chronic headaches	Score - phone questionnaire	Month 1
Secondary	Number of patients with chronic headaches	Score - phone questionnaire	Month 6
Secondary	Number of patients with chronic low back pain	Score - phone questionnaire	Month 1
Secondary	Number of patients with chronic low back pain	Score - phone questionnaire	Month 6
Secondary	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"	Month 1
Secondary	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"	Month 6
Secondary	Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)	Score - phone questionnaire	Month 1
Secondary	Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)	Score - phone questionnaire	Month 6
Secondary	Number of patients who have been rehospitalized	Score - phone questionnaire	Month 1
Secondary	Number of patients who have been rehospitalized	Score - phone questionnaire	Month 6
Secondary	Number of patients consulted for headaches	Score - phone questionnaire	Month 1
Secondary	Number of patients consulted for headaches	Score - phone questionnaire	Month 6
Secondary	Number of patients who received complementary treatments	Score - phone questionnaire	Month 1
Secondary	Number of patients who received complementary treatments	Score - phone questionnaire	Month 6
Secondary	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	Month 1
Secondary	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	Month 6