Bacterial VaginosisVaMapNCT03303859
Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I
An observational study of Bacterial Vaginosis, run by University Hospital Center of Martinique.
Trial summary
Preterm delivery is a public health priority in Martinique, a French oversees territory located in the Caribbean, with a rate of 10,5% substantially higher than in Continental France (7,5%). Bacterial vaginosis is an imbalance of vaginal flora known to be associated with preterm delivery risk. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Bacterial vaginosis
- How many people
- 511 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2013to 23 Jun 2017
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: Bacterial vaginosis appears much more prevalent in Martinique than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.
Who may be able to join
- All women followed-up since the beginning of pregnancy in the study center and supposed to deliver in this same center
Who cannot join
- Previous preterm delivery,
- Previous late abortion,
- Multiple pregnancy,
- Cervical cerclage before inclusion
About this study
Preterm delivery is a public health priority in Martinique, a French oversees territory located in the Caribbean, with a rate of 10,5% substantially higher than in Continental France (7,5%). Bacterial vaginosis is an imbalance of vaginal flora known to be associated with preterm delivery risk. Studies driven in the United States have pointed out that 50% of the excess in preterm birth rate observed in Afro-American population compared to Caucasian population may be attributable to infection. Bacterial vaginosis appears much more prevalent in our population than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.
Read the detailed description
Bacterial vaginosis during pregnancy is considered as a risk factor for preterm birth since the 1990's. A meta-analysis realized in 2003 found an Odds ratio of 2.4 for preterm delivery among women with bacterial vaginosis carriage, culminating at 7.5 when carriage before 17 weeks gestation was considered. Preterm delivery is a pregnancy complication known to be more prevalent among patients of African descent. Various hypothesis have been tested to account for this observed discrepancy and several authors consider that up to 50% of the difference in preterm delivery rate between Afro-american and Caucasians may have and infectious origin, with up to 30% attributable to a very different bacterial vaginosis carriage among patients of various ethnic origin. Several factors may interfere in the link observed between bacterial vaginosis and preterm delivery, which are also unevenly distributed among women of different ethnic origin. Exposure to stress, low socio-economic status, single marital status or low access to prenatal care are among those factors. Thus analyzing a relation between bacterial vaginosis and preterm delivery mandates to control for such factors. The present study will proceed to a vaginal sampling before 17 gestational age (GA) to diagnose a bacterial vaginosis through the Nugent score which is the standard diagnostic method for this pathology. At the same time, a written survey concerning stressful events in the past 12 months is submitted to volunteer patients in order to use the social readjustment rating scale by Holmes and Rahe and to account for the role of stress as a potential confounding factor. Socio-demographic data, obstetrical history and complications during pregnancy were also recorded and patients followed-up prospectively until delivery. Caregivers were blinded to the results of initial vaginal sampling. No alteration of the normal pregnancy follow-up was required by the study design.
- Conditions
- Bacterial Vaginosis
- Being tested
- Bacterial vaginosis
- Keywords
- Bacterial vaginosis, preterm delivery, Martinique, stress
- 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.
Bacterial vaginosisDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm delivery before 37 weeks gestation
Rate of preterm delivery
Measured: 37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start18 Dec 2013
- Primary completion26 Jun 2016
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc VOLUMENIE, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303859
- Sponsor's protocol ID
- 13/B/19
- Acronym
- VaMap
- Status last verified
- May 2018
- First submitted
- 3 Oct 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I
- ClinicalTrials.gov ID
- NCT03303859
- Acronym / sponsor ID
- VaMap / 13/B/19
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial vaginosis, preterm delivery, Martinique, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 18 Dec 2013 (actual)
- Primary completion
- 26 Jun 2016 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 6 Oct 2017 (actual)
- 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.
Preterm delivery is a public health priority in Martinique, a French oversees territory located in the Caribbean, with a rate of 10,5% substantially higher than in Continental France (7,5%). Bacterial vaginosis is an imbalance of vaginal flora known to be associated with preterm delivery risk. Studies driven in the United States have pointed out that 50% of the excess in preterm birth rate observed in Afro-American population compared to Caucasian population may be attributable to infection. Bacterial vaginosis appears much more prevalent in our population than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.
Detailed description
Bacterial vaginosis during pregnancy is considered as a risk factor for preterm birth since the 1990's. A meta-analysis realized in 2003 found an Odds ratio of 2.4 for preterm delivery among women with bacterial vaginosis carriage, culminating at 7.5 when carriage before 17 weeks gestation was considered. Preterm delivery is a pregnancy complication known to be more prevalent among patients of African descent. Various hypothesis have been tested to account for this observed discrepancy and several authors consider that up to 50% of the difference in preterm delivery rate between Afro-american and Caucasians may have and infectious origin, with up to 30% attributable to a very different bacterial vaginosis carriage among patients of various ethnic origin. Several factors may interfere in the link observed between bacterial vaginosis and preterm delivery, which are also unevenly distributed among women of different ethnic origin. Exposure to stress, low socio-economic status, single marital status or low access to prenatal care are among those factors. Thus analyzing a relation between bacterial vaginosis and preterm delivery mandates to control for such factors. The present study will proceed to a vaginal sampling before 17 gestational age (GA) to diagnose a bacterial vaginosis through the Nugent score which is the standard diagnostic method for this pathology. At the same time, a written survey concerning stressful events in the past 12 months is submitted to volunteer patients in order to use the social readjustment rating scale by Holmes and Rahe and to account for the role of stress as a potential confounding factor. Socio-demographic data, obstetrical history and complications during pregnancy were also recorded and patients followed-up prospectively until delivery. Caregivers were blinded to the results of initial vaginal sampling. No alteration of the normal pregnancy follow-up was required by the study design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Bacterial vaginosis appears much more prevalent in Martinique than in Continental France (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.
Key inclusion criteria (1 listed)
- All women followed-up since the beginning of pregnancy in the study center and supposed to deliver in this same center
Key exclusion criteria (4 listed)
- Previous preterm delivery,
- Previous late abortion,
- Multiple pregnancy,
- Cervical cerclage before inclusion
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 |
|---|---|---|
| Bacterial vaginosis | Diagnostic test | – |
Primary outcome
Preterm delivery before 37 weeks gestation
Time frame: 37 weeks gestation
Rate of preterm delivery
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 30 May 2018.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
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)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
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.
Jean-Luc VOLUMENIE principal investigator
CHU de Martinique
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Vaginosis, run by University Hospital Center of Martinique.
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 4 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 before 37 weeks gestation (time frame: 37 weeks gestation). 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 30 May 2018.