<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/NCT02199756</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-14-0370</org_study_id>
    <nct_id>NCT02199756</nct_id>
  </id_info>
  <brief_title>Nanovectors to Prevent Placental Passage of Tocolytic Agents</brief_title>
  <official_title>Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to find out whether indomethacin encapsulated within a nanovector&#xD;
      can stop contractions in pregnant human uterine tissue. Preterm delivery is a major&#xD;
      contributor to newborn deaths. The treatment of preterm labor includes medications that stop&#xD;
      contractions within the uterus, or womb. Indomethacin is effective in stopping uterine&#xD;
      contractions, but crosses the placenta to the unborn baby causing problems for the baby.&#xD;
      Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered&#xD;
      directly to the uterus using a nanovector, it may be an ideal medication to treat preterm&#xD;
      labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine&#xD;
      contractions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational study.&#xD;
&#xD;
      Subjects will undergo a biopsy from the middle of the upper margin of the uterine incision&#xD;
      measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean&#xD;
      section after delivery of the baby. Once the tissue is obtained, the site will be closed&#xD;
      using sutures similar to the usual closure of the uterus at cesarean section. This biopsy&#xD;
      will be taken to the laboratory to test whether the nanovector will increase or decrease&#xD;
      contractions in the uterus. Once this test is finished, the tissue will be frozen and test&#xD;
      for the absence or presence of the nanovector within the tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Uterine contractions</measure>
    <time_frame>3 hours</time_frame>
    <description>Uterine biopsies obtained from subjects will be placed in a specimen chamber that measures uterine contractility. Mean contractile intensity will be determined before and after exposure to oxytocin, indomethacin, liposomes and liposome indomethacin.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Preterm Labor</condition>
  <arm_group>
    <arm_group_label>Cesarean section</arm_group_label>
    <description>Women with cesarean section</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Uterine biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who will undergo elective cesarean section at term&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women undergoing elective cesarean section who are greater than 37 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerrie S Refuerzo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jerrie S Refuerzo, M.D.</last_name>
    <phone>713-500-6416</phone>
    <email>jerrie.s.refuerzo@uth.tmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Memorial Hermann Hospital Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Hutchinson, M.S.</last_name>
      <phone>713-500-6421</phone>
      <email>maria.keefer@uth.tmc.edu</email>
    </contact>
    <investigator>
      <last_name>Jerrie S Refuerzo, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>November 1, 2018</last_update_submitted>
  <last_update_submitted_qc>November 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Jerrie Refuerzo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Uterine contractions</keyword>
  <keyword>Indomethacin</keyword>
  <keyword>Nanovectors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor, Premature</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/NCT02199756
org study id: HSC-MS-14-0370
nct id: NCT02199756
lead sponsor: 
has dmc: No
The purpose of the study is to find out whether indomethacin encapsulated within a nanovector
      can stop contractions in pregnant human uterine tissue. Preterm delivery is a major
      contributor to newborn deaths. The treatment of preterm labor includes medications that stop
      contractions within the uterus, or womb. Indomethacin is effective in stopping uterine
      contractions, but crosses the placenta to the unborn baby causing problems for the baby.
      Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered
      directly to the uterus using a nanovector, it may be an ideal medication to treat preterm
      labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine
      contractions.
This is a prospective observational study.

      Subjects will undergo a biopsy from the middle of the upper margin of the uterine incision
      measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean
      section after delivery of the baby. Once the tissue is obtained, the site will be closed
      using sutures similar to the usual closure of the uterus at cesarean section. This biopsy
      will be taken to the laboratory to test whether the nanovector will increase or decrease
      contractions in the uterus. Once this test is finished, the tissue will be frozen and test
      for the absence or presence of the nanovector within the tissue.
observational model: Cohort
time perspective: Prospective
measure: Uterine contractions
time frame: 3 hours
description: Uterine biopsies obtained from subjects will be placed in a specimen chamber that measures uterine contractility. Mean contractile intensity will be determined before and after exposure to oxytocin, indomethacin, liposomes and liposome indomethacin.
arm group label: Cesarean section
description: Women with cesarean section
Uterine biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jerrie S Refuerzo, M.D.
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Jerrie S Refuerzo, M.D.
phone: 713-500-6416
email: jerrie.s.refuerzo@uth.tmc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Jerrie Refuerzo
investigator title: Associate Professor
mesh term: Obstetric Labor, Premature