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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05888324
Other study ID # APHP220572
Secondary ID 022-A00933-40
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
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