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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-49
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Deny of informed consent to study participation.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cervical-vaginal swab

    Procedure/Surgery

    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.

Treatment groups

96 Participants
are divided into 1 treatment group
Group A: ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline

Secondary outcomes

1

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

Time frame
At baseline

Other outcomes

Sponsors and contacts

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