<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03303859</url>
  </required_header>
  <id_info>
    <org_study_id>13/B/19</org_study_id>
    <nct_id>NCT03303859</nct_id>
  </id_info>
  <brief_title>Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I</brief_title>
  <acronym>VaMap</acronym>
  <official_title>Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preterm delivery is a public health priority in Martinique, a French oversees territory&#xD;
      located in the Caribbean, with a rate of 10,5% substantially higher than in Continental&#xD;
      France (7,5%). Bacterial vaginosis is an imbalance of vaginal flora known to be associated&#xD;
      with preterm delivery risk. Studies driven in the United States have pointed out that 50% of&#xD;
      the excess in preterm birth rate observed in Afro-American population compared to Caucasian&#xD;
      population may be attributable to infection. Bacterial vaginosis appears much more prevalent&#xD;
      in our population than in Continental France (approximatively 30% versus 7%) and may&#xD;
      constitute an explanation to the discrepancy in preterm delivery rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bacterial vaginosis during pregnancy is considered as a risk factor for preterm birth since&#xD;
      the 1990's. A meta-analysis realized in 2003 found an Odds ratio of 2.4 for preterm delivery&#xD;
      among women with bacterial vaginosis carriage, culminating at 7.5 when carriage before 17&#xD;
      weeks gestation was considered. Preterm delivery is a pregnancy complication known to be more&#xD;
      prevalent among patients of African descent. Various hypothesis have been tested to account&#xD;
      for this observed discrepancy and several authors consider that up to 50% of the difference&#xD;
      in preterm delivery rate between Afro-american and Caucasians may have and infectious origin,&#xD;
      with up to 30% attributable to a very different bacterial vaginosis carriage among patients&#xD;
      of various ethnic origin. Several factors may interfere in the link observed between&#xD;
      bacterial vaginosis and preterm delivery, which are also unevenly distributed among women of&#xD;
      different ethnic origin. Exposure to stress, low socio-economic status, single marital status&#xD;
      or low access to prenatal care are among those factors. Thus analyzing a relation between&#xD;
      bacterial vaginosis and preterm delivery mandates to control for such factors. The present&#xD;
      study will proceed to a vaginal sampling before 17 gestational age (GA) to diagnose a&#xD;
      bacterial vaginosis through the Nugent score which is the standard diagnostic method for this&#xD;
      pathology. At the same time, a written survey concerning stressful events in the past 12&#xD;
      months is submitted to volunteer patients in order to use the social readjustment rating&#xD;
      scale by Holmes and Rahe and to account for the role of stress as a potential confounding&#xD;
      factor. Socio-demographic data, obstetrical history and complications during pregnancy were&#xD;
      also recorded and patients followed-up prospectively until delivery. Caregivers were blinded&#xD;
      to the results of initial vaginal sampling. No alteration of the normal pregnancy follow-up&#xD;
      was required by the study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2013</start_date>
  <completion_date type="Actual">June 23, 2017</completion_date>
  <primary_completion_date type="Actual">June 26, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm delivery before 37 weeks gestation</measure>
    <time_frame>37 weeks gestation</time_frame>
    <description>Rate of preterm delivery</description>
  </primary_outcome>
  <enrollment type="Actual">511</enrollment>
  <condition>Bacterial Vaginosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bacterial vaginosis</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Bacterial vaginosis appears much more prevalent in Martinique than in Continental France&#xD;
        (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in&#xD;
        preterm delivery rate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women followed-up since the beginning of pregnancy in the study center and&#xD;
             supposed to deliver in this same center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous preterm delivery,&#xD;
&#xD;
          -  Previous late abortion,&#xD;
&#xD;
          -  Multiple pregnancy,&#xD;
&#xD;
          -  Cervical cerclage before inclusion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jean-Luc VOLUMENIE</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Martinique</affiliation>
  </overall_official>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>May 28, 2018</last_update_submitted>
  <last_update_submitted_qc>May 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bacterial vaginosis, preterm delivery, Martinique, stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03303859
org study id: 13/B/19
nct id: NCT03303859
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Preterm delivery before 37 weeks gestation
time frame: 37 weeks gestation
description: Rate of preterm delivery
intervention type: Diagnostic Test
intervention name: Bacterial vaginosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Jean-Luc VOLUMENIE
role: Principal Investigator
affiliation: CHU de Martinique
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Premature Birth
mesh term: Vaginal Diseases
sharing ipd: No