Evaluating the risks of neuraxial anesthesia in women with primary immunodeficiencies during childbirth
Infectious Complications Associated With the Use of Peri-partum Neuraxial Anaesthesia in Patients With Primary Immunodeficiencies
Assistance Publique - Hôpitaux de Paris · NCT06449066
This study is trying to see if using epidurals during childbirth is safe for women with primary immunodeficiencies by looking at any infections that might happen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, Ile De France) |
| Trial ID | NCT06449066 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the association between neuraxial anesthesia (epidural or intradural) used during childbirth and the occurrence of infectious complications, such as epidural abscess or meningitis, in women with primary immunodeficiencies (PID). The study will review medical records of PID patients who have given birth in APHP hospitals over the past decade. By focusing on this specific population, the research seeks to fill a gap in understanding the safety of neuraxial anesthesia in patients who are at a higher risk for infections. The findings could provide valuable insights into the management of labor pain in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients over 18 years old with primary immunodeficiencies who have given birth in the last 10 years.
Not a fit: Patients who are minors, deceased, or those whose obstetric files are unavailable will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety of neuraxial anesthesia for women with primary immunodeficiencies during childbirth.
How similar studies have performed: This study addresses a novel area of inquiry, as the risks associated with neuraxial anesthesia in patients with primary immunodeficiencies have not been previously studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, Ile De France
- Infectiology mobile team - Department of Infectious and Tropical Diseases — Paris, Ile De France, France (RECRUITING)
Study contacts
- Principal investigator: Caroline Charlier-Woerther — APHP
- Study coordinator: Aude Beloeuvre
- Email: Aude.BELOEUVRE@aphp.fr
- Phone: 00 33 1 58 41 19 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infectious Complications, Obstetrical Neuraxial Anaesthesia, Primary immunodeficiencies, Neuraxial anaesthesia, Obstetrical anaesthesia, Epidural abscess, Meningitis