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| ID | Type | Description | Link |
|---|---|---|---|
| 022-A00933-40 | Other Identifier | France : ANSM |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PDPH after epidural analgesia for labor, requiring BP | Patients with PDPH after epidural analgesia for labor, requiring BP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Questionnaires by phone at 1 and 6 months after inclusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of the conditions of the accidental breach | Data collection of diagnosis of the accidental breach :
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with chronic headaches | Score - phone questionnaire | Month 1 |
| Number of patients with chronic headaches | Score - phone questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward
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| Name | Affiliation | Role |
|---|---|---|
| Catherine FISCHER, MD | Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Port-Royal Maternity ward - Cochin Hopsital - APHP | Paris | ÃŽle-de-France Region | 75014 | France |
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| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 |
| 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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |