NCT05888324

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

November 14, 2022

Last Update Submit

September 5, 2025

Conditions

Blood PatchPost-Dural Puncture Headache

Keywords

Post Dural puncture headacheEpidural blood patchChronic headacheEpidural analgesiaObstetric anaesthesia

Outcome Measures

Primary Outcomes (26)

  • 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

  • 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)

    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

Secondary Outcomes (16)

  • Number of patients with chronic headaches

    Month 1

  • Number of patients with chronic headaches

    Month 6

  • Number of patients with chronic low back pain

    Month 1

  • Number of patients with chronic low back pain

    Month 6

  • Modified Headache Impact Questionnaire (HIT)

    Month 1

  • +11 more secondary outcomes

Study Arms (1)

Patients with PDPH after epidural analgesia for labor, requiring BP

Patients with PDPH after epidural analgesia for labor, requiring BP

Other: Questionnaires

Interventions

QuestionnairesOTHER

Questionnaires by phone at 1 and 6 months after inclusion

Patients with PDPH after epidural analgesia for labor, requiring BP

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Vaginal delivery or caesarean section with epidural at the Port Royal maternity ward

You may qualify if:

  • 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,

You may not qualify if:

  • Patient under curatorship or guardianship
  • Not speaking/understanding French
  • BP performed in another indication
  • Benefiting from the AME (state medical aid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Port-Royal Maternity ward - Cochin Hopsital - APHP

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Post-Dural Puncture HeadacheHeadache Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Catherine FISCHER, MD

    Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

June 5, 2023

Study Start

June 6, 2023

Primary Completion

April 23, 2025

Study Completion

January 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

FR(1)