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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-06

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache

NCT02427009

Post-Dural Puncture Headache

TERMINATED NA

Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.

NCT04696627

Post-Dural Puncture Headache Chronic Headache

COMPLETED

The Sphenopalatine Ganglion Block for Post-dural Puncture Headache

NCT03385772

Post-Dural Puncture Headache

UNKNOWN NA

Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)

NCT00373074

Post-Lumbar Puncture Headache

WITHDRAWN PHASE2/PHASE3

Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache

NCT02394457

Postdural Puncture Headache

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Patch Post-Dural Puncture Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with PDPH after epidural analgesia for labor, requiring BP

Questionnaires

Intervention Type OTHER

Questionnaires by phone at 1 and 6 months after inclusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaires

Questionnaires by phone at 1 and 6 months after inclusion

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No