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NCT Number: NCT07484256

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

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.

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Key information

Conditions

Female Genital Schistosomiasis Helminthiasis Infections Parasitic Diseases Schistosomiasis Trematode Infections Vector Borne Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

Location status: Recruiting

Location contact

Tamara Ursini

CONTACT

[email protected]

+390456013226

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cervical-vaginal swab

Procedure

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.

Primary outcomes

  1. Female Genital Schistosomiasis (FGS)

    Time frame: At baseline

    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.

Secondary outcomes

  1. Signs/symptoms

    Time frame: At baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Elvia Malo

CONTACT

[email protected]

+390456013111

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Acronym: MATCHING

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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