Vaginosis, BacterialPhase 3NCT00491270
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
A Phase 3 study testing VS Sense in people with Vaginosis, Bacterial and Abortion, Spontaneous, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
- What is being tested?
- VS Sense
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant subjects, aged 18-45 years, pregnancy week 26 to 36+6, with history of previous preterm delivery or with premature contractions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jacob Bornstein, MD contact
Israel1 site
Department of Obstetrics and Gynecology
Nahariya
Jacob Bornstein, MD
About this study
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.
Read the 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.
- Conditions
- Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
- Being tested
- VS Sense
- Keywords
- Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
- Medical subject headings
- Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS SenseDevice
An applicator to diagnose pH increase above 5.2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Collaborators
- Common Sense
- Investigators
- Jacob Bornstein, MD, Principal investigator, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491270
- Sponsor's protocol ID
- F-7-20.6-1 VER-1
- Status last verified
- May 2011
- First submitted
- 24 Jun 2007
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
- ClinicalTrials.gov ID
- NCT00491270
- Acronym / sponsor ID
- F-7-20.6-1 VER-1
- Conditions
- Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
- Keywords
- Vaginosis, Bacterial, Abortion, Spontaneous, Premature Birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Collaborators
- Common Sense
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant subjects, aged 18-45 years, pregnancy week 26 to 36+6, with history of previous preterm delivery or with premature contractions.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VS SenseAn applicator to diagnose pH increase above 5.2 | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
Related trials for Vaginosis, Bacterial
Enrolling by invitationObservational study
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Bornstein, MD contact
Jacob Bornstein, MD principal investigator
Western Galilee Hospital-Nahariya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VS Sense in people with Vaginosis, Bacterial and Abortion, Spontaneous, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Bornstein, MD (+972-4-9107720), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2011.