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Recruiting NCT07484256

MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact

Trial Parameters

Condition Female Genital Schistosomiasis
Sponsor IRCCS Sacro Cuore Don Calabria di Negrar
Study Type INTERVENTIONAL
Phase N/A
Enrollment 96
Sex FEMALE
Min Age 15 Years
Max Age 49 Years
Start Date 2025-02-20
Completion 2027-08
Interventions
Cervical-vaginal swab

Brief Summary

The aim of this study is to evaluate the prevalence of female genital schistosomiasis (FGS) in the migrant population with gynecological problems who access our center's dedicated outpatient clinic. Furthermore, we will address the relevance of FGS in women with clinical manifestations of the upper genital tract and evaluate the role of cervical-vaginal swabs in predicting upper genital tract involvement in schistosomiasis infection. The study is classified as experimental despite its descriptive objective of the prevalence of the infection of interest, as the vaginal swab and the PCR test performed on the swab and, if necessary, on the histological sample (collected during a possible interventional procedure performed for the patient's clinical needs) are not part of the standard clinical management of these cases but will be performed for the purposes of the study.

Eligibility 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.

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