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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

June 24, 2007
May 24, 2011
January 2011
January 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00491270 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
  • Vaginosis, Bacterial
  • Abortion, Spontaneous
  • Premature Birth
Device: VS Sense
An applicator to diagnose pH increase above 5.2
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
August 2013
January 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
Yes
Contact: Jacob Bornstein, MD +972-4-9107720
Israel
 
NCT00491270
F-7-20.6-1 VER-1
Yes
Commonsense, Commonsense, Cesarea
Western Galilee Hospital-Nahariya
Common Sense
Principal Investigator: Jacob Bornstein, MD Western Galilee Hospital-Nahariya
Western Galilee Hospital-Nahariya
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP