Female Genital Schistosomiasis in Migrant Women: A Pilot Study (GynoBizh)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schistosomiasis; Diagnostic
• Intervention / Treatment: Other: Gynecology consultation; Other: Transvaginal ultrasound; Other: PCR Schistosoma spp

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma OLIOSI, Dr; Phone Number: +33 1 45 21 21 21; Email: emma.oliosi@aphp.fr
• Study Contact Backup: Name: Stéphane JAUREGUIBERRY, Pr; Phone Number: +33 1 45 21 74 22; Email: stephane.jaureguiberry@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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	inclusion
Determining the presence of HIV, HBV and HCV co-infection	Percentage of co-infection by determination of HIV, HBV, HCV serology	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	inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2025
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 10, 2026

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: colposcopy; femal genital schistosomiasis; migrant women; Diagnostic pilot study; Schistosoma spp. PCR
• Additional Relevant MeSH Terms: Vector Borne Diseases; Infections; Parasitic Diseases; Helminthiasis; Trematode Infections; Schistosomiasis
• Other Study ID Numbers: APHP240729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No