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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

NCT01152528 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2010-06-29

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • Common Sense

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01152528 on ClinicalTrials.gov