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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Common Sense.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Common Sense
ClinicalTrials.gov Identifier:
NCT01152528
First received: June 28, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Vaginal Infections
Bacterial Vaginosis
Late Miscarriage
Preterm Birth
Preterm Premature Rupture of Membranes
 Device: VA-SENSE
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Further study details as provided by Common Sense:

Primary Outcome Measures:
  • Incidence of preterm birth, gestational week at delivery. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 248
Study Start Date: July 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: VA-SENSE
    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).
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subject with ruptured membranes.
  2. Subject with signs and symptoms of bacterial vaginosis or Trichomoniasis infections.
  3. Subject with blood in her vaginal secretions.
  4. Subject is currently participating in another clinical study.
  5. Subject is unable or unwilling to cooperate with study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152528

Contacts
Contact: Hadar Kessary, PhD 972-4-6277101 ext 126 HADAR@CS-COMMONSENSE.COM
Contact: Jacob Bornstein, Proffesor 972-4-9107517 mdjacob@techunix.technion.ac.il

Locations
Israel
Western Galilee Hospital Not yet recruiting
Nahariya, Western Galilee, Israel, 22100
Contact: hadar kessary, PhD     972-4-6277101 ext 1     HADAR@CS-COMMONSENSE.COM    
Contact: Jacob Bonstein, Prof     972-4-9107517     mdjacob@techunix.technion.ac.il    
Principal Investigator: Jacob Borenstein, Prof            
Sponsors and Collaborators
Common Sense
  More Information

No publications provided

Responsible Party: Hadar Kessary, Common Sense
ClinicalTrials.gov Identifier: NCT01152528     History of Changes
Other Study ID Numbers: F-7-27.3-1
Study First Received: June 28, 2010
Last Updated: June 28, 2010
Health Authority: Ministry of Health : Israel

Keywords provided by Common Sense:
bacterial vaginosis
screening
abortion
preterm delivery

Additional relevant MeSH terms:
Vaginal Diseases
Abortion, Spontaneous
Fetal Membranes, Premature Rupture
Vaginosis, Bacterial
Premature Birth
Rupture
Pregnancy Complications
 Obstetric Labor Complications
Bacterial Infections
Vaginitis
Genital Diseases, Female
Obstetric Labor, Premature
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013