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

Preterm Birth Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01152528
• Other study ID #: F-7-27.3-1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 28, 2010
• Last updated: June 28, 2010
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: Common Sense
• Contact: Hadar Kessary, PhD
• Phone: 972-4-6277101
• Email: HADAR[@]CS-COMMONSENSE.COM
• Is FDA regulated: No
• Health authority: Ministry of Health : Israel
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 248
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Nahariya	Western Galilee

Sponsors (1)

Lead Sponsor	Collaborator
Common Sense

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of preterm birth, gestational week at delivery.	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.	9 months	No