Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia

NCT06449066 | Completed

• 1 other identifier: APHP240481
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Infectious Complications (Epidural Abscess or Meningitis); Obstetrical Neuraxial Anaesthesia

Keywords

Primary immunodeficiencies; Neuraxial anaesthesia; Obstetrical anaesthesia; Epidural abscess; Meningitis

Outcome Measures

Primary Outcomes (1)

• Number of participants who develop a local or systemic infection, such as an epidural abscess or meningitis, within 28 days after receiving neuraxial anesthesia during delivery

  Occurrence of a local or systemic infection post-neuraxial anesthesia within 28 days after delivery / Infectious complication after obstetrical neuraxial anesthesia / Epidural abscess or meningitis after neuraxial anesthesia

  28 days post-partum

Secondary Outcomes (3)

• Frequency of Alternative Pain Relief Methods Utilized Due to Contraindications Linked to Primary Immunodeficiency

  During labour

• Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia

  up to 24 hours after birth

• Number of cases where maternity anesthetists identify contraindications to performing neuraxial anesthesia in patients with primary immunodeficiency

  During labour

Study Arms (1)

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

Other: Non applicable

Interventions

Non applicable OTHER

Non applicable (data collection)

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female eligible patients from the CEREDIH cohort will be included.

You may qualify if:

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

You may not qualify if:

• Refuse to participate
• Deceased
• Minor
• under judicial protection
• obstetric file not available

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Infectiology mobile team - Department of Infectious and Tropical Diseases

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

Location

Related Publications (1)

• 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.

  PMID: 40226770 BACKGROUND

MeSH Terms

Conditions

Epidural Abscess; Meningitis

Condition Hierarchy (Ancestors)

Perimeningeal Infections; Central Nervous System Infections; Infections; Abscess; Suppuration; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Caroline Charlier-Woerther

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 7, 2024
• Study Start: August 8, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FR (1)