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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01152528

Enrollment

248

Registered

2010-06-29

Start date

2010-07-31

Completion date

2011-06-30

Last updated

2010-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis, Late Miscarriage, Preterm Birth, Preterm Premature Rupture of Membranes, Vaginal Infections

Keywords

bacterial vaginosis, screening, abortion, preterm delivery

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.

Interventions

DEVICEVA-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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of preterm birth, gestational week at delivery.	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.

Countries

Israel

Contacts

Primary ContactHadar Kessary, PhD

HADAR@CS-COMMONSENSE.COM972-4-6277101

Backup ContactJacob Bornstein, Proffesor

mdjacob@techunix.technion.ac.il972-4-9107517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026