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

Phase 3

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

• Registration Number: NCT01152528
• Lead Sponsor: Common Sense

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Last Update Submitted: 2010-06-28
• Study First Posted: 2010-06-29
• Last Update Posted: 2010-06-29
• Study Start: 2010-07
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 248

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Western Galilee Hospital; 🇮🇱 Nahariya, Western Galilee, Israel