Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
- Conditions
- Primary Immune Deficiency Diseases
- Interventions
- Other: Questionnaire
- Registration Number
- NCT06519734
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- Brief 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.
- Detailed Description
Primary immune deficiency diseases (PIDDs) constitute a large group of genetic disorders of the immune system which associate 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 and the incidence is 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 not recommended in patients with PID.
IUDs are one of the most effective, long-lasting and low-cost methods of contraception, which have the major advantage of causing few drug interactions. Access to effective and appropriate contraception is a major issue for patients with PID because these patients have high-risk pregnancies. Multidisciplinary pregnancy planning allows for adaptation of anti-infective treatments and prophylaxis. These patients often have medication that may interfere with oral contraception, so IUDs could provide many benefits. The incidence of upper genital infections after insertion of an IUD in the general population is 1.6 cases per 1000 patient-years, with a risk 6 times higher in the 20 days after insertion. The risk of developing an upper genital infection is linked to the breakdown of the cervical mucus barrier and the introduction of bacteria from the lower genital tract into the uterine cavity.
The main infectious complication associated with the use of intravaginal menstrual protection is menstrual toxic shock syndrome, a rare but serious pathology caused by the production of the TSST-1 toxin by Staphylococcus aureus. The use of a tampon is one of the main risk factors identified and menstrual cups do not seem to be less likely to promote menstrual toxic shock syndrome. These risks lead to the use of tampons and menstrual cups being discouraged in patients with PID. However, there are no data in the literature on the association between immunosuppression and increased risk of menstrual toxic shock syndrome. Additionally, adult patients with PID will likely use these menstrual hygiene products during their lifetime.
It is therefore crucial to better characterize the risks incurred by patients with PID and the potential infectious complications associated with these devices.
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, and the treatment, the severity and the evolution of these complications.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- Adult woman with primary immune deficiency disease and registered in the reference Center for Hereditary Immune Deficits (CEREDIH, hospital Necker-Enfants Malades, Paris)
- Patient not opposed to participation in research
- Refusal to participate of the study
- Deceased patient
- Minor patient
- Patient under legal protection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Questionnaire Adult women registered in the Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Frequency of use of intrauterine devices, menstrual cups and tampons in patients with primary immunodeficiency Time 0 Frequency of use of intrauterine devices, menstrual cups or tampons reported by patients on the study questionnaire.
Trial Locations
- Locations (1)
H么pital Necker-Enfants Malades
馃嚝馃嚪Paris, France