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 | Unknown Phase 3 DMC

• 1 other identifier: F-7-27.3-1
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

bacterial vaginosis; screening; abortion; preterm delivery

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

VA-SENSE DEVICE

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).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant subjects, aged 18-50 years, pregnancy week 10 or less or 20 or less, with history of previous preterm delivery.
• Subject is ready to sign an informed consent form.

You may not qualify if:

• Subject with ruptured membranes.
• Subject with signs and symptoms of bacterial vaginosis or Trichomoniasis infections.
• Subject with blood in her vaginal secretions.
• Subject is currently participating in another clinical study.
• Subject is unable or unwilling to cooperate with study procedures.

Sponsors & Collaborators

• Common Sense: lead

Study Sites (1)

Western Galilee Hospital

Nahariya, Western Galilee, 22100, Israel

Location

MeSH Terms

Conditions

Vaginitis; Vaginosis, Bacterial; Premature Birth; Preterm Premature Rupture of the Membranes

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Central Study Contacts

Hadar Kessary, PhD

CONTACT

972-4-6277101; HADAR@CS-COMMONSENSE.COM

Jacob Bornstein, Proffesor

CONTACT

972-4-9107517; mdjacob@techunix.technion.ac.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

IL (1)