RecruitingNot ApplicableNCT07484256

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


Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Enrollment

96 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 15 YearsMax Age: 49 Years

Inclusion Criteria4

  • 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 Criteria1

  • Deny of informed consent to study participation.

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Interventions

PROCEDURECervical-vaginal swab

One cervical-vaginal swab will be collected by the gynecologist and will be sent to the parasitology laboratory of DITM for molecular detection of Schistosoma spp DNA using in-house real-time PCR.


Locations(1)

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, Italy

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NCT07484256