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Completed

NCT Number: NCT06449066

Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia

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).

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Key information

Conditions

Infectious Complications (Epidural Abscess or Meningitis) Abscess Central Nervous System Diseases Central Nervous System Infections Epidural Abscess Infections Meningitis Nervous System Diseases Neuroinflammatory Diseases Obstetrical Neuraxial Anaesthesia Perimeningeal Infections Suppuration

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Infectiology mobile team - Department of Infectious and Tropical Diseases

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non applicable

Other

Non applicable (data collection)

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

    Time frame: 28 days post-partum

    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

Secondary outcomes

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

    Time frame: During labour

    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

  2. Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia

    Time frame: up to 24 hours after birth

    Use of a antibioprophylaxis when performing neuraxial anesthesia

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

    Time frame: During labour

    Possible occurrence of contraindications identified by the maternity anesthetist to the performance of neuraxial anesthesia linked to primary immunodeficiency

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: ANEU-DIP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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