Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia (ANEU-DIP)

Infectious Complications Associated With the Use of Peri-partum Neuraxial Anaesthesia in Patients With Primary Immunodeficiencies

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).

Study Overview

• Status: Completed
• Conditions: Infectious Complications (Epidural Abscess or Meningitis); Obstetrical Neuraxial Anaesthesia
• Intervention / Treatment: Other: Non applicable

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Infectiology mobile team - Department of Infectious and Tropical Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female eligible patients from the CEREDIH cohort will be included.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Non applicable (data collection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Alternative Pain Relief Methods Utilized Due to Contraindications Linked to Primary Immunodeficiency	Use of an alternate method for pain-relief during childbirth / Use of another method of pain relief due to a contraindication linked to primary immunodeficiency	During labour
Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia	Use of a antibioprophylaxis when performing 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	Possible occurrence of contraindications identified by the maternity anesthetist to the performance of neuraxial anesthesia linked to primary immunodeficiency	During labour

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Caroline Charlier-Woerther, APHP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Meningitis; Primary immunodeficiencies; Neuraxial anaesthesia; Obstetrical anaesthesia; Epidural abscess
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Suppuration; Central Nervous System Infections; Abscess; Perimeningeal Infections; Meningitis; Epidural Abscess
• Other Study ID Numbers: APHP240481

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No