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

Western Galilee Hospital-Nahariya

Status and phase

Unknown

Phase 3

Conditions

Abortion, Spontaneous

Vaginosis, Bacterial

Premature Birth

Treatments

Device: VS Sense

Study type

Interventional

Funder types

Other

Identifiers

NCT00491270

F-7-20.6-1 VER-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.