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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01152528
Recruitment Status : Unknown
Verified June 2010 by Common Sense.
Recruitment status was:  Not yet recruiting
First Posted : June 29, 2010
Last Update Posted : June 29, 2010
Information provided by:
Common Sense

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Study Start Date : July 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

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).

Primary Outcome Measures :
  1. Incidence of preterm birth, gestational week at delivery. [ Time Frame: 9 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01152528

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Contact: Hadar Kessary, PhD 972-4-6277101 ext 126 HADAR@CS-COMMONSENSE.COM
Contact: Jacob Bornstein, Proffesor 972-4-9107517

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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   
Principal Investigator: Jacob Borenstein, Prof         
Sponsors and Collaborators
Common Sense

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Responsible Party: Hadar Kessary, Common Sense Identifier: NCT01152528     History of Changes
Other Study ID Numbers: F-7-27.3-1
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: June 2010
Keywords provided by Common Sense:
bacterial vaginosis
preterm delivery
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Premature Birth
Vaginal Diseases
Abortion, Spontaneous
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Genital Diseases, Female
Bacterial Infections