NCT07484256 MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact
| NCT ID | NCT07484256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar |
| Condition | Female Genital Schistosomiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2025-02-20 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07484256 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 49 Years, studying Female Genital Schistosomiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07484256 currently recruiting?
Yes, NCT07484256 is actively recruiting participants. Contact the research team at ricerca.clinica@sacrocuore.it for enrollment information.
Where is the NCT07484256 trial being conducted?
This trial is being conducted at Negrar, Italy.
Who is sponsoring the NCT07484256 clinical trial?
NCT07484256 is sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. The trial plans to enroll 96 participants.