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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Dural Puncture Headache; Blood Patch
• Intervention / Treatment: Other: Questionnaires

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Catherine FISCHER, MD; Phone Number: 00 33 1 58 41 39 26; Email: catherine.fischer2@aphp.fr
• Study Contact Backup: Name: Marie BENHAMMANI-GODARD; Phone Number: 00 33 1 58411190; Email: marie.godard@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Recruiting
      • Port-Royal Maternity ward - Cochin Hopsital - APHP
      • Contact: Catherine FISCHER, MD; Phone Number: 00 33 1 58 41 39 26; Email: catherine.fischer2@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with PDPH after epidural analgesia for labor, requiring BP	Other: Questionnaires; Questionnaires by phone at 1 and 6 months after inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to onset	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Positional	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Neck pain	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Analog visual scale (AVS)	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Neurosensory disorders	Description of the initial manifestations of post dural puncture acute headache (PDPH) : nature of PDPH	Immediately after BloodPatch procedure
Completion time after childbirth	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Volume injected	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Height of puncture compared to the initial breach	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Paresthesias	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Adverse events	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Duration of strict decubitus in the immediate afterglow	Description of the methods of carrying out the BloodPatch (BP)	Immediately after BloodPatch procedure
Age	Patient data collection	Immediately after BloodPatch procedure
Height	Patient data collection	Immediately after BloodPatch procedure
Weight	Patient data collection	Immediately after BloodPatch procedure
Parity	Patient data collection	Immediately after BloodPatch procedure
Mode of delivery	Patient data collection	Immediately after BloodPatch procedure
History of headaches or migraines before pregnancy	Patient data collection	Immediately after BloodPatch procedure
Initial treatment (before 1st BP)	Patient data collection NSAIDs and analgesics, sphenopalatine ganglion block, ACTH, caffeine, other	Immediately after BloodPatch procedure
Imaging	Patient data collection	1 month after last BloodPatch procedure
Lumbar punction	Patient data collection	1 month after last BloodPatch procedure
Other examinations if performed	Patient data collection	1 month after last BloodPatch procedure
Complications during the initial postpartum stay	Patient data collection	Immediately after BloodPatch procedure
Analog visual scale (AVS)	Patient data collection - Initial efficacy	Immediately after BloodPatch procedure
Analog visual scale (AVS)	Patient data collection - Initial efficacy	1 day after BloodPatch procedure
Analog visual scale (AVS)	Patient data collection - Initial efficacy	At exit of the hospital, up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with chronic headaches	Score - phone questionnaire	Month 1
Number of patients with chronic headaches	Score - phone questionnaire	Month 6
Number of patients with chronic low back pain	Score - phone questionnaire	Month 1
Number of patients with chronic low back pain	Score - phone questionnaire	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"	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"	Month 6
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)	Score - phone questionnaire	Month 1
Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)	Score - phone questionnaire	Month 6
Number of patients who have been rehospitalized	Score - phone questionnaire	Month 1
Number of patients who have been rehospitalized	Score - phone questionnaire	Month 6
Number of patients consulted for headaches	Score - phone questionnaire	Month 1
Number of patients consulted for headaches	Score - phone questionnaire	Month 6
Number of patients who received complementary treatments	Score - phone questionnaire	Month 1
Number of patients who received complementary treatments	Score - phone questionnaire	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	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	Month 6

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Catherine FISCHER, MD, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): December 6, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Epidural analgesia; Chronic headache; Epidural blood patch; Post Dural puncture headache; Obstetric anaesthesia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Secondary; Headache; Headache Disorders; Post-Dural Puncture Headache
• Other Study ID Numbers: APHP220572; 022-A00933-40 (Other Identifier: France : ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No