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Longitudinal Study of Vaginal Flora

Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora. It is present in 10 to 25% of women in the general population, and is the most common vaginal infection. It has been associated with a number of adverse sequelae in reproductive health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and complications of gynecological procedures. During pregnancy it has been associated with an increased risk of preterm birth an postpartum maternal infection. However, the vaginal microbial flora remains poorly understood. Information on variation in microbial flora and its association with BV from a longitudinal study is unavailable. This prospective observational study aims to advance our knowledge of the natural history and abnormal alteration in vaginal microbial flora, and to identify risk factors that are associated with these changes. A total of 5500 healthy, non-pregnant women of reproductive age will be enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every three months afterwards, totaling 5 visits). Detailed information on sociodemographic status, medical history, hygiene practice, sexual behavior and psychosocial stress will be collected through in-person interviews. Routine gynecological and dental examinations will be carried out during the study visits. Samples of vaginal secretion and blood will be collected. Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial vaginosis as well as common sexually transmitted diseases will be conducted. This project is expected to complete in 5 years.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora. It is present in 10 to 25% of women in the general population, and is the most common vaginal infection. It has been associated with a number of adverse sequelae in reproductive health including acquisition of HIV, pelvic inflammatory disease, cervical dysplasia, and complications of gynecological procedures. During pregnancy it has been associated with an increased risk of preterm birth and postpartum maternal infection. However, the vaginal microbial flora remains poorly understood. Information on variation in microbial flora and its association with BV from a longitudinal study is unavailable. This prospective observational study aims to advance our knowledge of the natural history and abnormal alteration in vaginal microbial flora, and to identify risk factors that are associated with these changes. A total of 5500 healthy, non-pregnant women of reproductive age will be enrolled and followed up in Birmingham, Alabama, for one year (baseline visit plus once every three months afterwards, totaling 5 visits). Detailed information on sociodemographic status, medical history, hygiene practice, sexual behavior and psychosocial stress will be collected through in-person interviews. Routine gynecological and dental examinations will be carried out during the study visits. Samples of vaginal secretion and blood will be collected. Laboratory tests to quantify vaginal microbial flora and to identify infection of bacterial vaginosis as well as common sexually transmitted diseases will be conducted. This project is expected to complete in 5 years.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

5500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Alabama
      • Birmingham, Alabama, Stati Uniti
        • University of Alabama

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 15 anni a 44 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

  • ELIGIBILITY CRITERIA:
  • Females, age 15-44.
  • Since bacterial vaginosis is primarily a condition of reproductive-age women, this study will be restricted to women regarded by demographers as reproductive age.
  • Non-pregnant women whose last menstrual period is later than expected will undergo a urine pregnancy test. Women who become pregnant while on study will complete their next regularly scheduled study visit, following which their participation will terminate.

EXCLUSION CRITERIA:

  1. Immunocompromised status

    Receiving or expected to receive in the next 12 months cytotoxic or immunosuppressive drugs.

    Receiving or expected to receive in the next 12 months one or more 30-day courses of corticosteroids.

    Congenital or acquired immune deficiency; known HIV positivity.

  2. Primary or secondary affective disorder, psychosis, emotional or intellectual limitations that preclude informed consent.
  3. Non-fluency in English.
  4. Post-menopausal (natural or surgical).
  5. Status post hysterectomy or expected to undergo hysterectomy in the next 12 months.
  6. Status post pelvic radiotherapy, or expected to undergo pelvic radiotherapy in the next 12 months.
  7. Receiving or expected to receive chronic (daily for at least 30 days) antibiotics in the next 12 months.
  8. Planning to move out of the area in the next 12 months.
  9. Participating or expected to participate during the next 12 months in a clinical trial in which antibiotics or topical microbicides will be administered in a blinded manner.
  10. Women who unexpectedly develop one of these conditions during their participation will continue to be followed, unless a specific contraindication arises.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

14 aprile 1999

Completamento dello studio

18 novembre 2010

Date di iscrizione allo studio

Primo inviato

19 giugno 2006

Primo inviato che soddisfa i criteri di controllo qualità

19 giugno 2006

Primo Inserito (Stima)

21 giugno 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2017

Ultimo verificato

18 novembre 2010

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 999999023
  • OH99-CH-N023

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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