<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/NCT01722708</url>
  </required_header>
  <id_info>
    <org_study_id>0012-12-EMC</org_study_id>
    <nct_id>NCT01722708</nct_id>
  </id_info>
  <brief_title>Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies</brief_title>
  <official_title>Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk&#xD;
      pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated.&#xD;
      Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The&#xD;
      purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the&#xD;
      treatment of abnormal vaginal flora in high risk pregnancies. For this purpose, pregnant&#xD;
      women who are considered high risk for preterm labor and were diagnosed with abnormal vaginal&#xD;
      flora will be randomly treated either with clindamycin or metronidazole. Eradication of the&#xD;
      abnormal flora and adverse effects will be monitored and compared&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">August 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora</measure>
    <time_frame>Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The prevalence of adverse effects</measure>
    <time_frame>During the antibacterial treatment which is 1 week of therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The prevalence of late abortions and preterm deliveries</measure>
    <time_frame>From date of randomization until the date of delivery or abortion, assessed up to 28 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the correlation between Nugent score , physical examination and Ph indicators</measure>
    <time_frame>The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Abnormal Vaginal Flora</condition>
  <condition>Clindamycin Vs Metronidazole</condition>
  <condition>High Risk Pregnancies for Preterm Labor</condition>
  <arm_group>
    <arm_group_label>clindamycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>metronidazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clindamycin</intervention_name>
    <description>Oral clindamycin 300 Milligrams*2/Day for a week</description>
    <arm_group_label>clindamycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole</intervention_name>
    <description>Oral metronidazole 500 Milligrams*2/Day for a week</description>
    <arm_group_label>metronidazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women at increased risk for preterm labor (preterm cervical effacement,&#xD;
             preterm uterine contractions, twins pregnancy, vaginal bleeding, past preterm&#xD;
             delivery)&#xD;
&#xD;
          -  Age above 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to the tested antibiotics&#xD;
&#xD;
          -  Antibacterial treatment in the week before the vaginal culture was taken&#xD;
&#xD;
          -  preterm premature rupture of membranes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zohar Nachum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departement of obstetric and gynecology, HaEmek medical center</name>
      <address>
        <city>Afula</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departement of obstetric and gynecology, Poriya Medical Center</name>
      <address>
        <city>Tiberias</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abnormal vaginal flora</keyword>
  <keyword>clindamycin Vs metronidazole</keyword>
  <keyword>High risk pregnancies for preterm labor</keyword>
  <keyword>Preterm labor</keyword>
  <keyword>Late abortion</keyword>
  <keyword>bacterial vaginosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01722708
org study id: 0012-12-EMC
nct id: NCT01722708
lead sponsor: 
has dmc: No
Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk
      pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated.
      Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The
      purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the
      treatment of abnormal vaginal flora in high risk pregnancies. For this purpose, pregnant
      women who are considered high risk for preterm labor and were diagnosed with abnormal vaginal
      flora will be randomly treated either with clindamycin or metronidazole. Eradication of the
      abnormal flora and adverse effects will be monitored and compared
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
time frame: Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment
measure: The prevalence of adverse effects
time frame: During the antibacterial treatment which is 1 week of therapy
measure: The prevalence of late abortions and preterm deliveries
time frame: From date of randomization until the date of delivery or abortion, assessed up to 28 weeks
measure: Assessing the correlation between Nugent score , physical examination and Ph indicators
time frame: The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation
arm group label: clindamycin
arm group type: Experimental
arm group label: metronidazole
arm group type: Experimental
intervention type: Drug
intervention name: Clindamycin
description: Oral clindamycin 300 Milligrams*2/Day for a week
arm group label: clindamycin
intervention type: Drug
intervention name: Metronidazole
description: Oral metronidazole 500 Milligrams*2/Day for a week
arm group label: metronidazole
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zohar Nachum, MD
role: Principal Investigator
affiliation: Departement of obstetric and gynecology, HaEmek medical center, Afula, Israel
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Obstetric Labor, Premature
mesh term: Metronidazole
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate