Primitive Immunodeficiency and Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Infectious events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Refusal to participate of the study
研究组 & 干预措施
Patients
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
干预措施: Questionnaire (Other)
结局指标
主要结局
Infectious events
时间窗: 18 months
Number of infectious events at any time during pregnancy and post-partum
次要结局
- Onset of pregnancy(Up to 50 years)
- Pregnancy outcomes(Up to 9 months)
- Occurrence of obstetric complications(9 months)
- Contraception effectiveness(Up to 50 years)
- Contraception complications(Up to 50 years)
- Screening of infections(9 months)
- Infectious gynecological complications(Up to 50 years)
- Treatments(9 months)
- Deaths and complications in the neonatal period(3 months)