Status:
UNKNOWN
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
Lead Sponsor:
Common Sense
Conditions:
Vaginal Infections
Bacterial Vaginosis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT01152528
Start Date
July 1 2010
End Date
June 1 2011
Last Update
June 29 2010
Active Locations (1)
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1
Western Galilee Hospital
Nahariya, Western Galilee, Israel, 22100