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

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ClinicalTrials.gov Identifier: NCT00491270
Recruitment Status : Unknown
Verified May 2011 by Western Galilee Hospital-Nahariya.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2007
Last Update Posted : May 25, 2011
Sponsor:
Collaborator:
Common Sense
Information provided by:
Western Galilee Hospital-Nahariya

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.

Condition or disease Intervention/treatment Phase
Vaginosis, Bacterial Abortion, Spontaneous Premature Birth Device: VS Sense Phase 3

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: VS Sense
    An applicator to diagnose pH increase above 5.2


Primary Outcome Measures :
  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. [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Commonsense, Commonsense, Cesarea
ClinicalTrials.gov Identifier: NCT00491270     History of Changes
Other Study ID Numbers: F-7-20.6-1 VER-1
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: May 2011

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

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