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

NCT ID: NCT00491270

Last Updated: 2011-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

Detailed 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.

Conditions

Vaginosis, Bacterial; Abortion, Spontaneous; Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

VS Sense

An applicator to diagnose pH increase above 5.2

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Common Sense

OTHER

Sponsor Role: collaborator

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Commonsense, Cesarea

Principal Investigators

Jacob Bornstein, MD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital-Nahariya

Locations

Department of Obstetrics and Gynecology

Nahariya, , Israel

Countries

Israel

Central Contacts

Jacob Bornstein, MD

Role: CONTACT

+972-4-9107720

Facility Contacts

Jacob Bornstein, MD

Role: primary

Other Identifiers

F-7-20.6-1 VER-1

Identifier Type: -

Identifier Source: org_study_id