Female genital schistosomiasis screening for migrant women with gynecologic symptoms in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Sacro Cuore Don Calabria hospital
  Negrar, Verona, Italy Recruiting

Study contacts

• Study coordinator: Elvia Malo
• Email: ricerca.clinica@sacrocuore.it
• Phone: +390456013111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.