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Screening for genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Vaginal self-sampling (VSS) has progressively emerged as an alternative to VCS for STI agent screening. The use of vaginal self-sampling (VSS) could facilitate follow-ups and potentially help in the prevention of gynaecological disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genital infections | Other | Women with vaginal/cervical sampling indications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal self-sampling | Procedure | The objective is to determine the non-inferiority of vaginal self-sampling compared with vaginal/cervical classical sampling, and evaluate the possibility of using it in all clinical situations indicating the prescription of such a procedure to screen for genital infections (GIs), sexually transmitted infections (STIs) and group B streptococcus (GBS) asymptomatic carriage in pregnant women. |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial infection detection rates | Bacterial infection detection rates of VSS compared with VCS | 10 days |
| Yeast infection detection rates | Yeast infection detection rates of VSS compared with VCS | 10 days |
| Chlamydia trachomatis detection rates | Chlamydia trachomatis detection rates of VSS compared with VCS | 10 days |
| Neisseria gonorrhoeae detection rates | Neisseria gonorrhoeae detection rates of VSS compared with VCS | 10 days |
| Mycoplasma genitalium detection rates | Mycoplasma genitalium detection rates of VSS compared with VCS | 10 days |
| Trichomonas vaginalis detection rates | Trichomonas vaginalis detection rates of VSS compared with VCS | 10 days |
| Human simplex virus detection rates | Human simplex virus detection rates of VSS compared with VCS | 10 days |
| Group B streptococcus detection rates | Group B streptococcus detection rates of VSS compared with VCS | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Hospital | Marseille | Bouches-du Rhone | 13003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18157061 | Result | Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, Schachter J, Holmes KK, Martin DH. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d. | |
| 26168051 |
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| ID | Term |
|---|---|
| D058345 | Asymptomatic Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D058070 | Asymptomatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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Participants were screenned for genital infections
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| Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |