An interventional study of Cervical-vaginal swab in Female Genital Schistosomiasis, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Diagnostic
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.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's planned enrollment of 96 is below the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Aug 2027, 30 months after the start.
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IRCCS Sacro Cuore Don Calabria di Negrar