Clinical trial NCT06449066: Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia
Official title: Infectious Complications Associated With the Use of Peri-partum Neuraxial Anaesthesia in Patients With Primary Immunodeficiencies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infectious Complications (Epidural Abscess or Meningitis)
Obstetrical Neuraxial Anaesthesia
Keywords: Primary immunodeficiencies
Neuraxial anaesthesia
Obstetrical anaesthesia
Epidural abscess
Meningitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female eligible patients from the CEREDIH cohort will be included.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 28 days post-partum
Secondary outcomes:
measure: Frequency of Alternative Pain Relief Methods Utilized Due to Contraindications Linked to Primary Immunodeficiency
timeFrame: During labour
measure: Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia
timeFrame: up to 24 hours after birth
measure: Number of cases where maternity anesthetists identify contraindications to performing neuraxial anesthesia in patients with primary immunodeficiency
timeFrame: During labour
Other outcomes:
Locations:
city: Paris
country: France
facility: Infectiology mobile team - Department of Infectious and Tropical Diseases
state: Ile De France
Study officials:
affiliation: APHP
name: Caroline Charlier-Woerther
role: PRINCIPAL_INVESTIGATOR
References: