Female Genital Schistosomiasis in Migrant Women: A Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-65
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Gynecology consultation
Other interventionGynecology consultation M0 - M3 - M6 - M12
Transvaginal ultrasound
Other interventionTransvaginal ultrasound
PCR Schistosoma spp
Other interventionPCR Schistosoma spp Colposcopy Cervical biopsy Cervical smear
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: groupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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
inclusion2
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
inclusion3
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
inclusion4
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
inclusionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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