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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00491270
Other study ID # F-7-20.6-1 VER-1
Secondary ID
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


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
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