Female genital schistosomiasis screening for migrant women with gynecologic symptoms in Italy
MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact
This study will test whether a cervical-vaginal swab with PCR can detect female genital schistosomiasis in migrant women of childbearing age who come to a gynecology clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 15 Years to 49 Years |
| Sex | Female |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Locations | 1 site (Negrar, Verona) |
| Trial ID | NCT07484256 on ClinicalTrials.gov |
What this trial studies
The study will enroll migrant women aged 15–49 from Schistosoma-endemic countries who present to a dedicated outpatient gynecology clinic in Negrar, Italy with symptoms compatible with female genital schistosomiasis. Participants will have a cervical-vaginal swab taken for PCR testing; if clinically indicated, tissue samples from routine interventional procedures may also be tested histologically and by PCR. The primary aims are to estimate the prevalence of FGS in this population and to determine whether swab PCR results predict involvement of the upper genital tract. Results will inform the clinical relevance of adding swab-based molecular testing into care pathways for migrants with gynecologic complaints.
Who should consider this trial
Good fit: Ideal candidates are migrant women aged 15–49 from Schistosoma-endemic countries who present to the outpatient gynecology clinic with one or more symptoms compatible with FGS and who provide informed consent.
Not a fit: Women who are asymptomatic, not from endemic areas, outside the 15–49 age range, who decline consent, or who have already received definitive antiparasitic treatment are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable earlier, less invasive diagnosis of FGS in migrant women and guide timely treatment to reduce complications like infertility or ectopic pregnancy.
How similar studies have performed: Prior smaller studies have used PCR on genital samples to detect Schistosoma DNA and suggested correlation with genital involvement, but evidence remains limited in migrant outpatient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * childbearing age (15-49 years); * origin from Schistosoma -endemic country; * presence of at least one of the following symptoms compatible with FGS: abnormal vaginal discharge, vaginal spotting/bleeding, genital itching or burning sensation, pelvic pain/dyspareunia, genital ulcers, macrohematuria, subfertility/infertility, miscarriage and/or extrauterine pregnancy, unexplained anemia, menstrual irregularities, previous birth of a premature/low birth weight fetus or growth retarded baby; * Informed consent to study participation and to personal data's treatment. Exclusion Criteria: * Deny of informed consent to study participation.
Where this trial is running
Negrar, Verona
- IRCCS Sacro Cuore Don Calabria hospital — Negrar, Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Elvia Malo
- Email: ricerca.clinica@sacrocuore.it
- Phone: +390456013111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.