Clinical trial NCT06828536: Female Genital Schistosomiasis in Migrant Women: A Pilot Study
Official title: Female Genital Schistosomiasis in Migrant Women: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diagnostic
Schistosomiasis
Keywords: femal genital schistosomiasis
migrant women
colposcopy
Diagnostic pilot study
Schistosoma spp. PCR
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study, "GynoBizh," investigates the frequency and clinical characteristics of female genital schistosomiasis (FGS) among migrant women from sub-Saharan Africa living in non-endemic countries. Schistosomiasis is a significant global parasitic disease, with a high seroprevalence in migrants. The study aims to assess the presence of genital lesions through gynecological examinations, colposcopy, and molecular tests, identifying diagnostic markers and associated health conditions. Fifty participants will be followed over a year to improve understanding and management of FGS in underserved populations.

Detailed description: Female genital schistosomiasis (FGS) is an underdiagnosed and under-researched condition, particularly in non-endemic regions, despite its significant prevalence among migrant women from sub-Saharan Africa. Schistosomiasis is the second most common parasitic disease globally, with a seroprevalence of up to 25% among migrants from endemic regions. FGS, characterized by genital lesions, often goes unrecognized due to a lack of awareness among healthcare providers in non-endemic countries and the absence of a gold-standard diagnostic method.

This pilot study, conducted at Bicêtre Hospital by Assistance Publique - Hôpitaux de Paris, seeks to evaluate the frequency of FGS-related genital lesions in a cohort of 50 women aged 25-65 years. Participants, all seropositive for schistosomiasis and originating from sub-Saharan Africa, will be recruited over six months and followed for one year. The study involves a comprehensive diagnostic approach, including gynecological examinations, colposcopy, endovaginal ultrasounds, and molecular tests (e.g., PCR on vaginal self-samples and cervical smears). Lesions identified during initial exams will be reassessed at follow-ups scheduled at 3, 6, and 12 months.

Secondary objectives include documenting participants' gynecological and obstetric histories, symptoms, and potential co-infections with HIV, HBV, and HCV. The study will also compare the effectiveness of different diagnostic tools for FGS and explore the presence of Schistosoma DNA in plasma and genital samples. Data will be collected through clinical assessments, questionnaires, and laboratory analyses, with results analyzed using robust statistical methods.

While the procedures are minimally invasive, risks are low and limited to mild discomfort from colposcopy and minor bleeding following biopsies. This study is expected to yield valuable insights into the prevalence and characteristics of FGS in non-endemic settings, addressing an overlooked health issue that disproportionately affects migrant women. By highlighting diagnostic challenges and identifying effective tools, this research aims to inform clinical guidelines, improve care, and advocate for targeted public health strategies for this vulnerable population.

Eligibility criteria: Inclusion Criteria:

* Women aged 25 to 65 years
* Born in a schistosomiasis-endemic area in sub-Saharan Africa
* With a positive serology by Schistosoma spp. Western Blot

Exclusion Criteria:

* Refusal to participate in the study
* Patient unable to provide consent
* Patient under guardianship or trusteeship
* Patient who is a virgin at the time of selection
* Patient who is pregnant at the time of selection

Primary outcomes:
measure: To determine the frequency of lower genital involvement due to schistosomiasis (perineum, vulva, vagina, cervix) in women born in endemic areas in sub-Saharan Africa and living in non-endemic countries who have positive serology for schistosomiasis
timeFrame: 12 months
Secondary outcomes:
measure: Take a gynaecological history of schistosomiasis-positive women with or without proven FGS (gestational age, parity, miscarriages, ectopic pregnancies, infertility, HPV infection, upper genital infection)
timeFrame: inclusion
measure: Describe the gynaecological and urological symptoms of patients infected with schistosomiasis
timeFrame: inclusion
measure: Describe the specific clinical lesions of FGS on colposcopy and vulvar and endovaginal examination
timeFrame: inclusion
measure: To describe the ultrasound lesions of the genital tract found in patients who are seropositive for schistosomiasis
timeFrame: inclusion
measure: Compare positivity rates of tests for FGS: (i) Schistosoma spp. PCR on vaginal self-sampling, (ii) lesions at colposcopy, (iii) Schistosoma spp. PCR on cervical/vaginal smears, (iv) cervical biopsy, (v) egg detection on cervical/vaginal smears
timeFrame: inclusion
measure: Determining the presence of HIV, HBV and HCV co-infection
timeFrame: inclusion
measure: To determine the presence of Schistosoma spp. DNA in plasma in the event of positive serology in this context of chronic bilharzian infection
timeFrame: inclusion
Other outcomes:
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