An interventional study of Gynecology consultation and Transvaginal ultrasound in Diagnostic and Schistosomiasis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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.
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.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's planned enrollment of 50 is below the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Compared within Schistosomiasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Other: Gynecology consultation · Other: Transvaginal ultrasound · Other: PCR Schistosoma spp
Gynecology consultation M0 - M3 - M6 - M12
Transvaginal ultrasound
PCR Schistosoma spp Colposcopy Cervical biopsy Cervical smear
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
The frequency of lower genital involvement in women who are seropositive for schistosomiasis, as seen on gynaecological examination of the vulva, vagina and cervix using the speculum and of the cervix using colposcopy, carried out during the dedicated gynaecology consultation prior to treatment
Time frame: 12 months
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)
Personal gynaecological history: number of pregnancies, number of children, miscarriages, ectopic pregnancies, percentage of infertility (defined as no pregnancy after 1 year of the trial), number of HPV infections (condyloma, cervical dysplasia), number of upper genital infections, etc.
Time frame: inclusion
Describe the gynaecological and urological symptoms of patients infected with schistosomiasis
Percentage of women with urological symptoms: dysuria, burning, nocturia, pollakiuria, macroscopic haematuria, microscopic haematuria
Time frame: inclusion
Describe the specific clinical lesions of FGS on colposcopy and vulvar and endovaginal examination
Percentage of women with gynaecological symptoms: vulvar pruritus, abnormal leucorrhoea, menometrorrhagia, dyspareunia, dysmenorrhoea, pelvic pain, etc.
Time frame: inclusion
To describe the ultrasound lesions of the genital tract found in patients who are seropositive for schistosomiasis
Percentage of women with ultrasound genital tract lesions compatible with schistosomiasis
Time frame: inclusion
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
Percentage of women with a positive test among : (i) Schistosoma spp. PCR on vaginal self-sampling, (ii) specific lesions seen at colposcopy, (iii) Schistosoma spp. PCR on cervical and vaginal smears, (iv) cervical biopsy, (v) egg testing on cervical and vaginal smears
Time frame: inclusion
Determining the presence of HIV, HBV and HCV co-infection
Percentage of co-infection by determination of HIV, HBV, HCV serology
Time frame: inclusion
To determine the presence of Schistosoma spp. DNA in plasma in the event of positive serology in this context of chronic bilharzian infection
Percentage of positive Schistosoma spp PCRs on vaginal self-sampling and Number of patients with Schistosoma spp PCR in serum
Time frame: inclusion
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Aug 2026, 18 months later.
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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