Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia

NCT ID: NCT06449066

Last Updated: 2025-09-12

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

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-08

Study Completion Date

2024-08-20

Brief Summary

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The purpose of this study is to evaluate if neuraxial anesthesia (epidural or intradural anesthesia) used during childbirth is associated with more frequent infectious complications in patients with primary immunodeficiencies (PID).

Detailed Description

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Neuraxial anaesthesia (epidural or intradural) is often used to alleviate pain during labour and childbirth. Although extremely efficient and safe, rare but serious infectious complications such as epidural abscess or meningitis can occur afterwards.

Patients with PID tend to have a greater risk of infectious complications than the general population. With the progress of medical care in those pathologies, female patients are now giving birth more often. The use of neuraxial anaesthesia and the associated infectious complications have never been studied in this population.

The investigators intend to review the medical records of PID patients who gave birth in an APHP hospital in the last 10 years to evaluate the use of neuraxial anesthesia and the frequency of infectious complications associated with neuraxial anesthesia.

Conditions

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Infectious Complications (Epidural Abscess or Meningitis) Obstetrical Neuraxial Anaesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

CEREDIH (centre de reference des deficits immunitaires héréditaires) cohort Female patients, alive and \> 18 years old, registered at the CEREDIH who gave birth in an APHP maternity

Non applicable

Intervention Type OTHER

Non applicable (data collection)

Interventions

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Non applicable

Non applicable (data collection)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female patient included in the CEREDIH national register
* Aged \> 18 years

Exclusion Criteria

* Refuse to participate
* Deceased
* Minor
* under judicial protection
* obstetric file not available
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Charlier-Woerther

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Infectiology mobile team - Department of Infectious and Tropical Diseases

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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Beloeuvre A, Anselem O, Tazi A, Keita-Meyer H, Mahlaoui N, Charlier C. Anesthetic management of women with primary immunodeficiencies in the obstetric setting: A French cohort study (ANEU-DIP). J Allergy Clin Immunol Glob. 2025 Jan 30;4(2):100433. doi: 10.1016/j.jacig.2025.100433. eCollection 2025 May.

Reference Type BACKGROUND
PMID: 40226770 (View on PubMed)

Other Identifiers

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APHP240481

Identifier Type: -

Identifier Source: org_study_id

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