Back to resultsVa-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery
Primary Purpose
Vaginal Infections, Bacterial Vaginosis, Late Miscarriage
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
VA-SENSE
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginal Infections focused on measuring bacterial vaginosis, screening, abortion, preterm delivery
Eligibility Criteria
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.
Sites / Locations
- Western Galilee Hospital
Outcomes
Primary Outcome Measures
Incidence of preterm birth, gestational week at delivery.
Each participant will use at least 8 VA-SENSE (maximum 20 TPLs), once a week for at least 8 weeks (maximum 20 weeks), or will be screened by VS-SENSE once during pregnancy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01152528
Brief Title
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
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Common Sense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Infections, Bacterial Vaginosis, Late Miscarriage, Preterm Birth, Preterm Premature Rupture of Membranes
Keywords
bacterial vaginosis, screening, abortion, preterm delivery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
VA-SENSE
Intervention Description
The VA-SENSE contains a strip of pH indicator (color indicator) that is sensitive to the acidity level. A change in the color of the strip due to changes in the acidity level of vaginal secretions absorbed in the panty liner clearly indicates high probability of bacterial or parasitic vaginal infection. Any color change that results from contact with urine will disappear 10 minutes of drying out, and then the color of the indicator strip will fade back to the original color (yellow).
Primary Outcome Measure Information:
Title
Incidence of preterm birth, gestational week at delivery.
Description
Each participant will use at least 8 VA-SENSE (maximum 20 TPLs), once a week for at least 8 weeks (maximum 20 weeks), or will be screened by VS-SENSE once during pregnancy.
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadar Kessary, PhD
Phone
972-4-6277101
Ext
126
Email
HADAR@CS-COMMONSENSE.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Bornstein, Proffesor
Phone
972-4-9107517
Email
mdjacob@techunix.technion.ac.il
Facility Information:
Facility Name
Western Galilee Hospital
City
Nahariya
State/Province
Western Galilee
ZIP/Postal Code
22100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hadar kessary, PhD
Phone
972-4-6277101
Ext
1
Email
HADAR@CS-COMMONSENSE.COM
First Name & Middle Initial & Last Name & Degree
Jacob Bonstein, Prof
Phone
972-4-9107517
Email
mdjacob@techunix.technion.ac.il
First Name & Middle Initial & Last Name & Degree
Jacob Borenstein, Prof
12. IPD Sharing Statement
Learn more about this trial
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
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