UnknownPhase 3

Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery

Israel248 participantsStarted 2010-07

Plain-language summary

The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion criteria

✓. Pregnant subjects, aged 18-50 years, pregnancy week 10 or less or 20 or less, with history of previous preterm delivery.
✓. Subject is ready to sign an informed consent form.

Exclusion criteria

✕. Subject with ruptured membranes.
✕. Subject with signs and symptoms of bacterial vaginosis or Trichomoniasis infections.
✕. Subject with blood in her vaginal secretions.
✕. Subject is currently participating in another clinical study.
✕. Subject is unable or unwilling to cooperate with study procedures.

What they're measuring

Incidence of preterm birth, gestational week at delivery.

Timeframe: 9 months

Trial details

NCT IDNCT01152528

SponsorCommon Sense

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

Contact for this trial

Hadar Kessary, PhD

972-4-6277101 HADAR@CS-COMMONSENSE.COM

View on ClinicalTrials.gov More Vaginal Infections trials