Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery

Western Galilee Hospital-Nahariya100 enrolled

Overview

To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.

This is an open-label, comparative, and prospective study. Pregnant women, pregnancy week 26 to 36+6, between the ages 18-45, who were hospitalized in the high risk department, with history of previous preterm delivery and/or with premature contractions. Patient with premature ruptured membrane will be excluded. In the hospital pregnant women with history of previous preterm delivery or with premature contractions, (participants) will be examined by speculum with no lubricant, The clinician will use the VS-SENSE to sample vaginal secretions and will immediately observe and record the color obtained.Should the VS-SENSE produce positive results the physician will consider giving clindamycin treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

100

Conditions

Vaginosis, Bacterial Abortion, Spontaneous Premature Birth

Interventions

VS SenseDEVICE

An applicator to diagnose pH increase above 5.2

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant subjects, aged 18-45 years, pregnancy week 26 to 36+6, with history of previous preterm delivery or with premature contractions. Exclusion Criteria: * Subject with ruptured membranes. * Subject with signs and symptoms of pelvic inflammatory disease. * Subject who has used vaginal douching within 12 hours prior to arrival at the hospital. * Subject who has applied local antiseptic, antibiotic or vaginal treatment within the previous 3 days. * Subjects who have had sexual intercourse within the last 12 hours. * Subject with blood in her vaginal secretions. * Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study. * Subject is unable or unwilling to cooperate with study procedures.

Locations (1)

Department of Obstetrics and Gynecology

Nahariya, Israel

Outcomes

Primary Outcomes

Does screening for BV using VS-SENSE in pregnant women with h/o preterm delivery or with premature contractions, and treatment will reduce or prevent Late miscarriage, preterm birth, preterm PROM, chorioamnionitis, and postpartum endometritis.

Time frame: One year

Central Contacts

Jacob Bornstein, MD

CONTACT

+972-4-9107720

Data from ClinicalTrials.gov

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