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

Common Sense Ltd.

Status and phase: Unknown; Phase 3

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

Treatments: Device: VA-SENSE

Study type: Interventional

Funder types: Other

Identifiers

NCT01152528

F-7-27.3-1

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind