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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00491270
• Other study ID #: F-7-20.6-1 VER-1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 24, 2007
• Last updated: May 24, 2011
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: May 2011
• Source: Western Galilee Hospital-Nahariya
• Contact: Jacob Bornstein, MD
• Phone: +972-4-9107720
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Premature Birth
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
Israel	Department of Obstetrics and Gynecology	Nahariya

Sponsors (2)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya	Common Sense

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		One year	No