Back to resultsBacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
Primary Purpose
Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
VS Sense
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginosis, Bacterial focused on measuring Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
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.
Sites / Locations
- Department of Obstetrics and Gynecology
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00491270
First Posted
June 24, 2007
Last Updated
May 24, 2011
Sponsor
Western Galilee Hospital-Nahariya
Collaborators
Common Sense
1. Study Identification
Unique Protocol Identification Number
NCT00491270
Brief Title
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
Official Title
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Western Galilee Hospital-Nahariya
Collaborators
Common Sense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
Keywords
Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
VS Sense
Intervention Description
An applicator to diagnose pH increase above 5.2
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Bornstein, MD
Phone
+972-4-9107720
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Bornstein, MD
Organizational Affiliation
Western Galilee Hospital-Nahariya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
Nahariya
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Bornstein, MD
12. IPD Sharing Statement
Learn more about this trial
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
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