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

May 24, 2011 updated by: Western Galilee Hospital-Nahariya
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jacob Bornstein, MD
  • Phone Number: +972-4-9107720

Study Locations

  • Israel
      • Nahariya, Israel
        • Department of Obstetrics and gynecology
        • Contact:
          • Jacob Bornstein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Collaborators

Common Sense

Investigators

  • Principal Investigator: Jacob Bornstein, MD, Western Galilee Hospital-Nahariya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

June 24, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 26, 2007

Study Record Updates

Last Update Posted (Estimate)

May 25, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-7-20.6-1 VER-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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