Clinical trial NCT05888324: Factors Associated With the Onset of Chronic Headaches in Patients Who Received a Blood Patch in Post Partum
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Patch
Post-Dural Puncture Headache
Keywords: Post Dural puncture headache
Epidural blood patch
Chronic headache
Epidural analgesia
Obstetric anaesthesia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Description of the conditions of the accidental breach
timeFrame: Immediately after BloodPatch procedure
measure: Time to onset
timeFrame: Immediately after BloodPatch procedure
measure: Positional
timeFrame: Immediately after BloodPatch procedure
measure: Neck pain
timeFrame: Immediately after BloodPatch procedure
measure: Analog visual scale (AVS)
timeFrame: Immediately after BloodPatch procedure
measure: Neurosensory disorders
timeFrame: Immediately after BloodPatch procedure
measure: Completion time after childbirth
timeFrame: Immediately after BloodPatch procedure
measure: Volume injected
timeFrame: Immediately after BloodPatch procedure
measure: Height of puncture compared to the initial breach
timeFrame: Immediately after BloodPatch procedure
measure: Paresthesias
timeFrame: Immediately after BloodPatch procedure
measure: Adverse events
timeFrame: Immediately after BloodPatch procedure
measure: Duration of strict decubitus in the immediate afterglow
timeFrame: Immediately after BloodPatch procedure
measure: Age
timeFrame: Immediately after BloodPatch procedure
measure: Height
timeFrame: Immediately after BloodPatch procedure
measure: Weight
timeFrame: Immediately after BloodPatch procedure
measure: Parity
timeFrame: Immediately after BloodPatch procedure
measure: Mode of delivery
timeFrame: Immediately after BloodPatch procedure
measure: History of headaches or migraines before pregnancy
timeFrame: Immediately after BloodPatch procedure
measure: Initial treatment (before 1st BP)
timeFrame: Immediately after BloodPatch procedure
measure: Imaging
timeFrame: 1 month after last BloodPatch procedure
measure: Lumbar punction
timeFrame: 1 month after last BloodPatch procedure
measure: Other examinations if performed
timeFrame: 1 month after last BloodPatch procedure
measure: Complications during the initial postpartum stay
timeFrame: Immediately after BloodPatch procedure
measure: Analog visual scale (AVS)
timeFrame: Immediately after BloodPatch procedure
measure: Analog visual scale (AVS)
timeFrame: 1 day after BloodPatch procedure
measure: Analog visual scale (AVS)
timeFrame: At exit of the hospital, up to 2 weeks
Secondary outcomes:
measure: Number of patients with chronic headaches
timeFrame: Month 1
measure: Number of patients with chronic headaches
timeFrame: Month 6
measure: Number of patients with chronic low back pain
timeFrame: Month 1
measure: Number of patients with chronic low back pain
timeFrame: Month 6
measure: Modified Headache Impact Questionnaire (HIT)
timeFrame: Month 1
measure: Modified Headache Impact Questionnaire (HIT)
timeFrame: Month 6
measure: Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)
timeFrame: Month 1
measure: Number of patients with late recurrence of typical post dural puncture acute headache (PDPH)
timeFrame: Month 6
measure: Number of patients who have been rehospitalized
timeFrame: Month 1
measure: Number of patients who have been rehospitalized
timeFrame: Month 6
measure: Number of patients consulted for headaches
timeFrame: Month 1
measure: Number of patients consulted for headaches
timeFrame: Month 6
measure: Number of patients who received complementary treatments
timeFrame: Month 1
measure: Number of patients who received complementary treatments
timeFrame: Month 6
measure: Patient data collection
timeFrame: Month 1
measure: Patient data collection
timeFrame: Month 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Port-Royal Maternity ward - Cochin Hopsital - APHP
state: Ile De France
Study officials:
affiliation: Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Catherine FISCHER, MD
role: PRINCIPAL_INVESTIGATOR
References: