PregnancyNCT00799500
Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing
A study testing Screening in people with Pregnancy and Bacterial Vaginosis, run by Montse Palacio at 1 site in Spain.
Trial summary
Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Bacterial Vaginosis, Preterm Delivery
- What is being tested?
- Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,049 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Dec 2010
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women
Who cannot join
- Diabetes mellitus (pre-gestational)
- Hypertension (pre-gestational)
- Malformations on ultrasonography at 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.
Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.
- Conditions
- Pregnancy, Bacterial Vaginosis, Preterm Delivery
- Being tested
- Screening
- Medical subject headings
- Vaginosis, Bacterial, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Weekly vaginal pH
| Study group | Role | What they receive |
|---|---|---|
| Weekly screening | Experimental | Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination. Receives: Other: Screening |
| Observation | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montse Palacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Montse Palacio, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799500
- Sponsor's protocol ID
- FIS06/0559
- Status last verified
- Apr 2013
- First submitted
- 28 Nov 2008
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.
- ClinicalTrials.gov ID
- NCT00799500
- Acronym / sponsor ID
- FIS06/0559
- Conditions
- Pregnancy, Bacterial Vaginosis, Preterm Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,049 participants (actual)
- Lead sponsor
- Montse PalacioUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Dec 2008 (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.
Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly screening | Experimental | Other: ScreeningScreening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination. |
| Observation | No intervention | –Usual care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women
Key exclusion criteria (3 listed)
- Diabetes mellitus (pre-gestational)
- Hypertension (pre-gestational)
- Malformations on ultrasonography at 12 weeks
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 |
|---|---|---|
| ScreeningWeekly vaginal pH | Other | Weekly screening |
Primary outcome
Preterm delivery rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Pregnancy and Bacterial Vaginosis, run by Montse Palacio at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 5 Apr 2013. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm delivery rate (time frame: 12 months). 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 5 Apr 2013.