Primitive Immunodeficiency and Pregnancy
- Conditions
- Primary Immune Deficiency
- Interventions
- Other: Questionnaire
- Registration Number
- NCT04581460
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- Brief Summary
The management of patients with primary immune deficiency is increasingly codified, however contraception and pregnancy have not yet extensively studied or codified, and the medical monitoring and the prevention of infectious complications thus remains at the discretion of the practitioner.
The aim the research is to study the obstetric features and outcome of patients with primary immune defects.
- Detailed Description
Primary immune deficiencies constitute a large group of immune system disorders of genetic origin which can associate, to varying degrees, an increased susceptibility to infections and immunopathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, tumors malignant.
Although their prevalence remains underestimated, there has been an increase in the number of cases diagnosed in the past 10 years. The national average prevalence is 8.6 patients per 100,000 inhabitants and the diagnostic incidence is 400 new cases per year in France. Major improvement in the management of primary immunodeficiencies have drastically changed patients outcome. Most patients now reach adulthood and the possibility of carrying out a pregnancy project, that has already reported for patients suffering from hypogammaglobulinemia or variable common immune deficiency, is now increasingly reported for other types of inherited immunodeficiencies. Whereas the management of patients with hereditary immunodeficiencies is increasingly codified, contraception and pregnancy have not yet been the subject of recommendations: medical monitoring and the prevention of infectious complications thus remain at the discretion of the practitioner.
The aim the research is to study the obstetric experiences of patients with a primary immune deficiency, paying particular attention to infectious complications.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
- Adult woman with Hereditary Immune Deficits and entered in the reference Center for Hereditary Immune Deficits (CEREDIH, hospital Necker-Enfants Malades, Paris) register
- Patient having reported at least one pregnancy or attempted pregnancy
- Patient not opposing to participation in research
- Refusal to participate of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Questionnaire Patients entered in the register of the reference Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris, and having reported at least one pregnancy or attempted pregnancy
- Primary Outcome Measures
Name Time Method Infectious events 18 months Number of infectious events at any time during pregnancy and post-partum
- Secondary Outcome Measures
Name Time Method Pregnancy outcomes Up to 9 months Rate of early or late miscarriage, completed pregnancy, live birth and childbearing
Occurrence of obstetric complications 9 months Rate of obstetric complications
Contraception effectiveness Up to 50 years Number of unwanted pregnancies
Contraception complications Up to 50 years Number of non-infectious complications of contraception
Deaths and complications in the neonatal period 3 months Number of complications during neonatal period, including death
Onset of pregnancy Up to 50 years Number of pregnancies during reproductive age period
Screening of infections 9 months Presence/absence of screening for infections
Infectious gynecological complications Up to 50 years Number of infectious gynecological complications during contraception
Treatments 9 months Number of treatments aiming at preventing infections
Trial Locations
- Locations (1)
H么pital Necker-Enfants Malades
馃嚝馃嚪Paris, France