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

This study is not yet open for participant recruitment.
Verified May 2011 by Western Galilee Hospital-Nahariya
Sponsor:
Collaborator:
Common Sense
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00491270
First received: June 24, 2007
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Vaginosis, Bacterial
Abortion, Spontaneous
Premature Birth
 Device: VS Sense
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
Official Title: Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Further study details as provided by Western Galilee Hospital-Nahariya:

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. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: VS Sense
    An applicator to diagnose pH increase above 5.2
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491270

Contacts
Contact: Jacob Bornstein, MD +972-4-9107720

Locations
Israel
Department of Obstetrics and Gynecology Not yet recruiting
Nahariya, Israel
Contact: Jacob Bornstein, MD            
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Common Sense
Investigators
Principal Investigator: Jacob Bornstein, MD Western Galilee Hospital-Nahariya
  More Information

No publications provided

Responsible Party: Commonsense, Commonsense, Cesarea
ClinicalTrials.gov Identifier: NCT00491270     History of Changes
Other Study ID Numbers: F-7-20.6-1 VER-1
Study First Received: June 24, 2007
Last Updated: May 24, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Western Galilee Hospital-Nahariya:
Vaginosis, Bacterial
Abortion, Spontaneous
Premature Birth

Additional relevant MeSH terms:
Abortion, Spontaneous
Vaginosis, Bacterial
Premature Birth
Pregnancy Complications
Bacterial Infections
 Vaginitis
Vaginal Diseases
Genital Diseases, Female
Obstetric Labor, Premature
Obstetric Labor Complications

ClinicalTrials.gov processed this record on May 23, 2013