<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/NCT02208011</url>
  </required_header>
  <id_info>
    <org_study_id>L8608-W13010</org_study_id>
    <nct_id>NCT02208011</nct_id>
  </id_info>
  <brief_title>A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes</brief_title>
  <official_title>A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University, Baton Rouge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Woman's Hospital, Louisiana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Innovations, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Louisiana State University, Baton Rouge</source>
  <brief_summary>
    <textblock>
      Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as&#xD;
      compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart&#xD;
      review after delivery.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
        -  English speaking&#xD;
&#xD;
        -  pregnant woman &gt;15 weeks gestation undergoing an exam for ruptured membranes&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
        -  Known placental previa&#xD;
&#xD;
        -  Active vaginal bleeding&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>evidence of ruptured membranes</measure>
    <time_frame>up to delivery of infant</time_frame>
  </primary_outcome>
  <enrollment type="Actual">140</enrollment>
  <condition>Evidence of Ruptured Membranes in Women Greater Than 15 Weekd</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured&#xD;
        membranes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  complaint of ruptured membranes&#xD;
&#xD;
          -  IUP &gt; 15 weeks gestation&#xD;
&#xD;
          -  English speaking, over the age of 18yrs old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active bleeding&#xD;
&#xD;
          -  placenta previa&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Woman's Hospital</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University, Baton Rouge</investigator_affiliation>
    <investigator_full_name>Iro Igbinosa</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
  </condition_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/NCT02208011
org study id: L8608-W13010
nct id: NCT02208011
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as
      compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart
      review after delivery.

      Inclusion Criteria:

        -  English speaking

        -  pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes

      Exclusion Criteria:

        -  Known placental previa

        -  Active vaginal bleeding
observational model: Cohort
time perspective: Prospective
measure: evidence of ruptured membranes
time frame: up to delivery of infant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University, Baton Rouge
investigator full name: Iro Igbinosa
investigator title: M.D.
mesh term: Fetal Membranes, Premature Rupture