NCT06828536

Female Genital Schistosomiasis in Migrant Women: A Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diagnostic
• Schistosomiasis

Interventions

Type	Name	Description
OTHER	Gynecology consultation	Gynecology consultation M0 - M3 - M6 - M12
OTHER	Transvaginal ultrasound	Transvaginal ultrasound
OTHER	PCR Schistosoma spp	PCR Schistosoma spp Colposcopy Cervical biopsy Cervical smear

Timeline

• Start date: 2025-02-10
• Primary completion: 2026-08-10
• Completion: 2026-08-10
• First posted: 2025-02-14
• Last updated: 2025-02-14