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

N/AActive Not RecruitingNCT05888324

Assistance Publique - Hôpitaux de Paris98 enrolled

Overview

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.

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

Conditions

Blood Patch Post-Dural Puncture Headache

Interventions

QuestionnairesOTHER

Questionnaires by phone at 1 and 6 months after inclusion

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Port-Royal Maternity ward - Cochin Hopsital - APHP

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

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

Time to onset

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

Time frame: Immediately after BloodPatch procedure

Positional

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

Time frame: Immediately after BloodPatch procedure

Neck pain

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

Time frame: Immediately after BloodPatch procedure

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

Neurosensory disorders

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

Time frame: Immediately after BloodPatch procedure

Completion time after childbirth

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

Time frame: Immediately after BloodPatch procedure

Volume injected

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

Data from ClinicalTrials.gov

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Time frame: Immediately after BloodPatch procedure

Height of puncture compared to the initial breach

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

Time frame: Immediately after BloodPatch procedure

Paresthesias

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

Time frame: Immediately after BloodPatch procedure

Adverse events

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

Time frame: Immediately after BloodPatch procedure

Duration of strict decubitus in the immediate afterglow

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

Time frame: Immediately after BloodPatch procedure

Age

Patient data collection

Time frame: Immediately after BloodPatch procedure

Height

Patient data collection

Time frame: Immediately after BloodPatch procedure

Weight

Patient data collection

Time frame: Immediately after BloodPatch procedure

Parity

Patient data collection

Time frame: Immediately after BloodPatch procedure

Mode of delivery

Patient data collection

Time frame: Immediately after BloodPatch procedure

History of headaches or migraines before pregnancy

Patient data collection

Time frame: Immediately after BloodPatch procedure

Initial treatment (before 1st BP)

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

Time frame: Immediately after BloodPatch procedure

Imaging

Patient data collection

Time frame: 1 month after last BloodPatch procedure

Lumbar punction

Patient data collection

Time frame: 1 month after last BloodPatch procedure

Other examinations if performed

Patient data collection

Time frame: 1 month after last BloodPatch procedure

Complications during the initial postpartum stay

Patient data collection

Time frame: Immediately after BloodPatch procedure

Analog visual scale (AVS)

Patient data collection - Initial efficacy

Time frame: Immediately after BloodPatch procedure

Analog visual scale (AVS)

Patient data collection - Initial efficacy

Time frame: 1 day after BloodPatch procedure

Analog visual scale (AVS)

Patient data collection - Initial efficacy

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

Secondary Outcomes

Number of patients with chronic headaches

Score - phone questionnaire

Time frame: Month 1

Number of patients with chronic headaches

Score - phone questionnaire

Time frame: Month 6

Number of patients with chronic low back pain

Score - phone questionnaire

Time frame: Month 1

Number of patients with chronic low back pain

Score - phone questionnaire

Time frame: 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"

Time frame: 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"

Time frame: Month 6

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

Score - phone questionnaire

Time frame: Month 1

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

Score - phone questionnaire

Time frame: Month 6

Number of patients who have been rehospitalized

Score - phone questionnaire

Time frame: Month 1

Number of patients who have been rehospitalized

Score - phone questionnaire

Time frame: Month 6

Number of patients consulted for headaches

Score - phone questionnaire

Time frame: Month 1

Number of patients consulted for headaches

Score - phone questionnaire

Time frame: Month 6

Number of patients who received complementary treatments

Score - phone questionnaire

Time frame: Month 1

Number of patients who received complementary treatments

Score - phone questionnaire

Time frame: 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

Time frame: 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

Time frame: Month 6