Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519734
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Primitive Immunodeficiency Intrauterine Devices and Menstrual Hygiene Products
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Primitive Immunodeficiency Intrauterine Devices and Menstrual Hygiene Products
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEMIDIP
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 86 patients per 100000 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
Although their prevalence remains underestimated there has been an increase in cases diagnosed in the last 10 years The national average prevalence is 86 patients per 100000 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 86 patients per 100000 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 16 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
Although their prevalence remains underestimated there has been an increase in cases diagnosed in the last 10 years The national average prevalence is 86 patients per 100000 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 16 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None