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

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.

Study Overview

• Status: Recruiting
• Conditions: Female Genital Schistosomiasis
• Intervention / Treatment: Procedure: Cervical-vaginal swab

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456013111; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria hospital
      • Contact: Tamara Ursini; Phone Number: +390456013226; Email: tamara.ursini@sacrocuore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants; Women diagnosed with schistosomiasis and complaining gynecological symptoms will be referred to the gynecologist. Upon gynecological evaluation, informed consent to enrolment in the study will be sought. If necessary, cultural mediation will be requested for the collection of consent. One cervical-vaginal swab will be collected by the gynecologist, being specifically performed for the study purpose. For patients requiring hysteroscopy, hysterectomy or other procedures entailing collection/removal of endometrial tissue, part of retrieved biological material will be collected for molecular analysis. During the hysteroscopic examination/hysterectomy/revision of uterine cavity, bioptic samples will be collected as per standard procedure, part of which will be used for routine histological examination at the pathological anatomy department, and the leftover will be sent to the parasitology laboratory for molecular detection of Schistosoma spp DNA using in-house real-time PCR.

Procedure: Cervical-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Genital Schistosomiasis (FGS)	Proportion of FGS cases, defined as women with the given symptoms/signs and positive real-time PCR on cervical-vaginal swab and/or biopsy over the total number of women tested.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs/symptoms	Frequency of specific signs/symptoms (Y/N) in patients diagnosed 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 -histopathological features (presence of Schistosoma eggs in female genital tissues),; UGT involvement	At baseline

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: female; schistosomiasis; genital
• Additional Relevant MeSH Terms: Vector Borne Diseases; Infections; Parasitic Diseases; Helminthiasis; Trematode Infections; Schistosomiasis
• Other Study ID Numbers: 2024-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No