Infectious Complications (Epidural Abscess or Meningitis)ANEU-DIPNCT06449066
Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia
An observational study of Infectious Complications (Epidural Abscess or Meningitis) and Obstetrical Neuraxial Anaesthesia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infectious Complications (Epidural Abscess or Meningitis), Obstetrical Neuraxial Anaesthesia
- What is being tested?
- Non applicable
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2024to 20 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female eligible patients from the CEREDIH cohort will be included.
Who may be able to join
- Female patient included in the CEREDIH national register
- Aged > 18 years
Who cannot join
- Refuse to participate
- Deceased
- Minor
- under judicial protection
- obstetric file not available
Trial locations and contacts
1 site in 1 country.
France1 site
Infectiology mobile team - Department of Infectious and Tropical Diseases
Paris, Île-de-France Region, 75014
About this study
Official title: 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).
Read the 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.
- Conditions
- Infectious Complications (Epidural Abscess or Meningitis), Obstetrical Neuraxial Anaesthesia
- Being tested
- Non applicable
- Keywords
- Primary immunodeficiencies, Neuraxial anaesthesia, Obstetrical anaesthesia, Epidural abscess, Meningitis
- Medical subject headings
- Epidural Abscess, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
Non applicable (data collection)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Non applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days post-partum
Secondary outcomes (3)
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
Measured: During labour
Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia
Use of a antibioprophylaxis when performing neuraxial anesthesia
Measured: 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
Measured: During labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start8 Aug 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious Complications (Epidural Abscess or Meningitis)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Caroline Charlier-Woerther, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449066
- Sponsor's protocol ID
- APHP240481
- Acronym
- ANEU-DIP
- Status last verified
- Sep 2025
- First submitted
- 30 May 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40226770
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious Complications Associated With the Use of Peri-partum Neuraxial Anaesthesia in Patients With Primary Immunodeficiencies
- ClinicalTrials.gov ID
- NCT06449066
- Acronym / sponsor ID
- ANEU-DIP / APHP240481
- Conditions
- Infectious Complications (Epidural Abscess or Meningitis), Obstetrical Neuraxial Anaesthesia
- Keywords
- Primary immunodeficiencies, Neuraxial anaesthesia, Obstetrical anaesthesia, Epidural abscess, Meningitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Non applicableCEREDIH (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female eligible patients from the CEREDIH cohort will be included.
Key inclusion criteria (2 listed)
- Female patient included in the CEREDIH national register
- Aged > 18 years
Key exclusion criteria (5 listed)
- Refuse to participate
- Deceased
- Minor
- under judicial protection
- obstetric file not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non applicableNon applicable (data collection) | Other | Patients |
Primary outcome
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
3 secondary outcomes
Frequency of Alternative Pain Relief Methods Utilized Due to Contraindications Linked to Primary Immunodeficiency
Time frame: During labour
Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia
Time frame: up to 24 hours after birth
Number of cases where maternity anesthetists identify contraindications to performing neuraxial anesthesia in patients with primary immunodeficiency
Time frame: During labour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 40226770Beloeuvre 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Charlier-Woerther principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Complications (Epidural Abscess or Meningitis) and Obstetrical Neuraxial Anaesthesia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 28 days post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.