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

NCT00491270 | Unknown Phase 3 DMC

• 1 other identifier: F-7-20.6-1 VER-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginosis, Bacterial; Abortion, Spontaneous; Premature Birth

Keywords

Vaginosis, Bacterial; Abortion, Spontaneous; Premature Birth

Outcome Measures

Primary Outcomes (1)

• 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.

  One year

Interventions

VS Sense DEVICE

An applicator to diagnose pH increase above 5.2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant subjects, aged 18-45 years, pregnancy week 26 to 36+6, with history of previous preterm delivery or with premature contractions.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead
• Common Sense: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology

Nahariya, Israel

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Abortion, Spontaneous; Premature Birth

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Jacob Bornstein, MD

  Western Galilee Hospital-Nahariya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Bornstein, MD

CONTACT

+972-4-9107720

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 24, 2007
• First Posted: June 26, 2007
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: August 1, 2013
• Last Updated: May 25, 2011

Record last verified: 2011-05

Locations

IL (1)