Va-Sense

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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bacterial vaginosis screening abortion preterm delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Common Sense

Locations

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Western Galilee Hospital

Nahariya, Western Galilee, Israel

Site Status

Countries

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Israel

Central Contacts

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Hadar Kessary, PhD

Role: CONTACT

Phone: 972-4-6277101

Email: [email protected]

Jacob Bornstein, Proffesor

Role: CONTACT

Phone: 972-4-9107517

Email: [email protected]

Facility Contacts

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hadar kessary, PhD

Role: primary

Jacob Bonstein, Prof

Role: backup

Other Identifiers

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F-7-27.3-1

Identifier Type: -

Identifier Source: org_study_id

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