Female Genital Schistosomiasis
Conditions
Keywords
female, genital, schistosomiasis
Brief 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.
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.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Genital Schistosomiasis (FGS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Signs/symptoms | 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 |
Countries
Italy
Contacts
CONTACTElvia Malo
Outcome results
None listed