Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products

Condition(s) studied

Investigational drug(s) / intervention(s)

Questionnaire: Questionnaire intended for patients on contraceptive modalities and use of menstrual hygiene products. Consultation of the medical records of patients who have reported infectious complications linked to the use of intrauterine devices, tampons or menstrual cups.

Study summary

Primary immune deficiency diseases (PIDDs) constitute a large group of genetic disorders of the immune system which associates to varying degrees an increased susceptibility to infections and immuno-pathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, malignancy.

Although their prevalence remains underestimated, there has been an increase in cases diagnosed in the last 10 years. The national average prevalence is 8.6 patients per 100,000 inhabitants with an incidence of 400 new cases per year in France. Life expectancy varies depending on the type of deficiency, and its impact in terms of infectious complications or malignancy.

With therapeutic progress, life expectancy increases, and more patients are concerned by contraception and menstrual hygiene. Due to the lack of data and for fear of an infectious complication, the use of intrauterine devices (IUD) and tampons or menstrual cups is traditionally advised against in patients with PID.

The objective of the research is to study the contraception methods and menstrual hygiene products used by patients with primary immunodeficiency and to evaluate related infectious complications.

The contraceptive methods of these patients, the occurrence of upper genital infections associated with the use of an intrauterine device, the severity and the evolution of these infections will be evaluated. A possible refusal to insert an intrauterine device by a healthcare professional due to primary immunodeficiency will also be studied.

Likewise, the types of menstrual hygiene products used will be studied - napkins, menstrual cups, tampons, menstrual panties -, as well as the possible occurrence of associated infectious complications - in particular menstrual toxic shock syndrome, and the treatment, severity and evolution of these complications.

Eligibility

Primary outcome measure(s)

• Occurrence of infectious complications associated with the use of intrauterine devices and tampons or menstrual cups in patients with primary immunodeficiency — Time 0
  Occurrence of an infectious complication - upper genital infection or menstrual toxic shock - associated with the use of an intrauterine device, tampon or menstrual cup in patients with primary immunodeficiency. These complications will be declared by patients via the study questionnaire and then confirmed by consultation of the medical file.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France