<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/NCT02983240</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601699 - A</org_study_id>
    <secondary_id>OCR26522</secondary_id>
    <secondary_id>E-BIO CORP</secondary_id>
    <nct_id>NCT02983240</nct_id>
  </id_info>
  <brief_title>Electrical Inhibition of Human Preterm Contractions</brief_title>
  <official_title>Electrical Inhibition (EI): A Preliminary Study to Prevent the Uterine Contractions of Human Preterm Labor and Preterm Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>e-Bio Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>e-Bio Corp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore a new method to stop preterm uterine contractions&#xD;
      using an electrical device. The device, an &quot;electrical pacemaker for the uterus,&quot; has been&#xD;
      approved by the Food and Drug Administration (FDA) for clinical research in pregnant women.&#xD;
      The purpose of this study is to evaluate the feasibility and safety of the device. The&#xD;
      investigators hypothesize that human preterm uterine contractions can be safely and&#xD;
      objectively inhibited with a weak electrical current provided by an electrical inhibition&#xD;
      (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI&#xD;
      exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the effectiveness of a new method of preventing the&#xD;
      human preterm uterine contractions of labor during electrical monitoring. The objective is to&#xD;
      test a method for the inhibition of human preterm uterine contractions with an electrical&#xD;
      pacemaker, electrical inhibition (EI). The study will investigate EI associated changes in&#xD;
      preterm uterine contraction frequency as monitored by objective uterine tocodynamometry and&#xD;
      adjunct electromyography (EMG) and electrohysterogram (EHG). The endpoint is the&#xD;
      statistically significant EI induced decrease in the gold standard tocodynamometric monitored&#xD;
      preterm uterine contraction frequency. The adjunct EMG and EHG monitoring provides valuable&#xD;
      adjunct data about the electrical activity of the preterm uterine contractions and the effect&#xD;
      of EI on this activity.&#xD;
&#xD;
      The investigators hypothesize that human preterm uterine contractions can be safely and&#xD;
      objectively inhibited with a weak electrical current provided by an electrical inhibition&#xD;
      (EI)/uterine pacemaker device. This effect can be assessed by the use of a non-invasive&#xD;
      tocodynamometer. It has been previously been shown that the frequency of contractions during&#xD;
      preterm labor can be lowered by EI applied by the use of an intravaginal catheter carrying&#xD;
      electrodes similar to a cardiac pacemaker (Karsdon et al). The investigators hypothesize that&#xD;
      this effect relates to the timing and length of EI exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">January 21, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 21, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring</measure>
    <time_frame>Change from 20, 40, and 80 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>FHR pattern as measured by the maternal-fetal monitor</measure>
    <time_frame>Change from 60 and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EMG monitoring as measured by LaborView Device</measure>
    <time_frame>Change from 60 and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EHG monitoring as measured by LaborView Device</measure>
    <time_frame>Change from 60 and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fECG monitoring as measured by LaborView Device</measure>
    <time_frame>Change from 60 and 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal pain medication administration</measure>
    <time_frame>Before and after use of electrical uterine pacemaker, assessed up to 120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal heart rate</measure>
    <time_frame>Change from 60 and 120 minutes</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>Before and after use of electrical uterine pacemaker, assessed up to 120 minutes</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Preterm Labor</condition>
  <condition>PreTerm Birth</condition>
  <condition>Preterm Labor With Delivery Nos</condition>
  <arm_group>
    <arm_group_label>60 Minute Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 20-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>80 Minute Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 40-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>120 Minute Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 80-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical Uterine Pacemaker</intervention_name>
    <description>The catheter is placed under ultrasound guidance into the posterior vaginal fornix next to the external cervical os. The electrode connectors are attached to the EI device. Activating the EI device involves: 1) turning the current pulse duration rotary dial clockwise to the desired setting; this is an important setting and should be set at 20ms; 2) turning the current frequency rotary dial clockwise to the desired setting; 3) turn on the EI device on with the on/off toggle switch; 4) SLOWLY turning the current strength rotary dial clockwise to the desired setting, at this time the red light should be flashing. Usually 5-10mA of current is sufficient, but 20 mA is a maximum. Based on the tocometer recordings the least amount of EI current is given to inhibit the uterine contractions.</description>
    <arm_group_label>120 Minute Study</arm_group_label>
    <arm_group_label>60 Minute Study</arm_group_label>
    <arm_group_label>80 Minute Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Wong-Baker pain score ≤ 6&#xD;
&#xD;
          -  Pregnancy Depression Scale score &lt; 16&#xD;
&#xD;
          -  Informed consent form signed and dated by patient&#xD;
&#xD;
          -  Be willing and able to comply with study requirements&#xD;
&#xD;
          -  Be between 18-50 years of age&#xD;
&#xD;
          -  Be between 23 to 36 5/7 weeks pregnant with a singleton gestation&#xD;
&#xD;
          -  Cervical dilation of ≤ 6 cm&#xD;
&#xD;
          -  A normal spontaneous vaginal delivery (NSVD) expected&#xD;
&#xD;
          -  Suspected to have preterm labor, as defined by the American College of Obstetricians&#xD;
             and Gynecologists and the American Academy of Pediatrics, as follows.78&#xD;
&#xD;
               -  Persistent uterine contractions (4 every 20 minutes, or 8 every 60 minutes)&#xD;
&#xD;
               -  And any one or more of the following:&#xD;
&#xD;
               -  Documented cervical change&#xD;
&#xD;
               -  1 cm cervical dilatation and progressing&#xD;
&#xD;
                  -&gt; 80% cervical effacement&#xD;
&#xD;
               -  Be admitted to the maternity unit with the diagnosis of preterm labor or preterm&#xD;
                  contractions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe preeclampsia&#xD;
&#xD;
          -  Severe abruption placenta&#xD;
&#xD;
          -  Abnormal placentation (i.e. placenta previa)&#xD;
&#xD;
          -  Rupture of amniotic membranes&#xD;
&#xD;
          -  Active preterm labor with cervical dilation &gt; 6 cm&#xD;
&#xD;
          -  Exposed amniotic membranes&#xD;
&#xD;
          -  Vaginal bleeding &gt; 10 cc&#xD;
&#xD;
          -  Frank chorioamnionitis&#xD;
&#xD;
          -  Fetal death&#xD;
&#xD;
          -  Fetal anomaly incompatible with life&#xD;
&#xD;
          -  Severe fetal growth restriction (EFW &lt; 5%)&#xD;
&#xD;
          -  Uterine anomalies (i.e. bicornuate uterus, uterine didelphys)&#xD;
&#xD;
          -  Mature fetal lung studies&#xD;
&#xD;
          -  Maternal cardiac arrhythmias&#xD;
&#xD;
          -  HIV, Hepatitis C, Hepatitis B&#xD;
&#xD;
          -  History of herpes simplex virus (HSV)&#xD;
&#xD;
          -  A permanent cardiac pacemaker&#xD;
&#xD;
          -  A fetal cardiac arrhythmia&#xD;
&#xD;
          -  Contraindication for tocolysis e.g. premature rupture of the amniotic membranes&#xD;
             allowing for ascending intrauterine infection with group B streptococcus or GBS (beta&#xD;
             hemolytic streptococcus, S. agalactiae) or other micro-organisms.&#xD;
&#xD;
          -  IV or po narcotic pain medication &lt; 12 hours prior to admission (regional anesthesia,&#xD;
             long acting oral maintenance opiates i.e. methadone, Suboxone, Subutex not included in&#xD;
             exclusion criteria)&#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>Jeffrey Karsdon, MD</last_name>
    <role>Study Chair</role>
    <affiliation>New York University Lagone Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Smulian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>John Smulian, MD</last_name>
    <phone>352-273-7580</phone>
    <email>jsmulian@ufl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Smulian, MD</last_name>
      <phone>352-273-7580</phone>
      <email>jsmulian@ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeffrey Karsdon, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fred Naftolin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Smulian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lauren Silva, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Erica Smith, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcella Rodriguez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tony Wen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Samuel Wu, PHD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136.</citation>
    <PMID>23089601</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Obstetric Labor, Premature</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/NCT02983240
org study id: IRB201601699 - A
secondary id: OCR26522
secondary id: E-BIO CORP
nct id: NCT02983240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to explore a new method to stop preterm uterine contractions
      using an electrical device. The device, an "electrical pacemaker for the uterus," has been
      approved by the Food and Drug Administration (FDA) for clinical research in pregnant women.
      The purpose of this study is to evaluate the feasibility and safety of the device. The
      investigators hypothesize that human preterm uterine contractions can be safely and
      objectively inhibited with a weak electrical current provided by an electrical inhibition
      (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI
      exposure.
The purpose of this study is to determine the effectiveness of a new method of preventing the
      human preterm uterine contractions of labor during electrical monitoring. The objective is to
      test a method for the inhibition of human preterm uterine contractions with an electrical
      pacemaker, electrical inhibition (EI). The study will investigate EI associated changes in
      preterm uterine contraction frequency as monitored by objective uterine tocodynamometry and
      adjunct electromyography (EMG) and electrohysterogram (EHG). The endpoint is the
      statistically significant EI induced decrease in the gold standard tocodynamometric monitored
      preterm uterine contraction frequency. The adjunct EMG and EHG monitoring provides valuable
      adjunct data about the electrical activity of the preterm uterine contractions and the effect
      of EI on this activity.

      The investigators hypothesize that human preterm uterine contractions can be safely and
      objectively inhibited with a weak electrical current provided by an electrical inhibition
      (EI)/uterine pacemaker device. This effect can be assessed by the use of a non-invasive
      tocodynamometer. It has been previously been shown that the frequency of contractions during
      preterm labor can be lowered by EI applied by the use of an intravaginal catheter carrying
      electrodes similar to a cardiac pacemaker (Karsdon et al). The investigators hypothesize that
      this effect relates to the timing and length of EI exposure.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Uterine contraction frequency during labor as measured by external uterine tocodynamometric monitoring
time frame: Change from 20, 40, and 80 minutes
measure: FHR pattern as measured by the maternal-fetal monitor
time frame: Change from 60 and 120 minutes
measure: EMG monitoring as measured by LaborView Device
time frame: Change from 60 and 120 minutes
measure: EHG monitoring as measured by LaborView Device
time frame: Change from 60 and 120 minutes
measure: fECG monitoring as measured by LaborView Device
time frame: Change from 60 and 120 minutes
measure: Maternal pain medication administration
time frame: Before and after use of electrical uterine pacemaker, assessed up to 120 minutes
measure: Maternal heart rate
time frame: Change from 60 and 120 minutes
measure: Adverse events
time frame: Before and after use of electrical uterine pacemaker, assessed up to 120 minutes
arm group label: 60 Minute Study
arm group type: Experimental
description: After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 20-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.
arm group label: 80 Minute Study
arm group type: Experimental
description: After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 40-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.
arm group label: 120 Minute Study
arm group type: Experimental
description: After a 20-minute pre-intervention control period the electrical inhibition will be used intermittently, only when there is monitored contraction, during the 80-minute intervention study period. At the end of the intervention period there will be a 20-minute post-intervention control period. The FHR patterns, tocogram, EMG and EHG, and fECG recordings will be compared to before and after the use of the electrical uterine pacemaker device.
intervention type: Device
intervention name: Electrical Uterine Pacemaker
description: The catheter is placed under ultrasound guidance into the posterior vaginal fornix next to the external cervical os. The electrode connectors are attached to the EI device. Activating the EI device involves: 1) turning the current pulse duration rotary dial clockwise to the desired setting; this is an important setting and should be set at 20ms; 2) turning the current frequency rotary dial clockwise to the desired setting; 3) turn on the EI device on with the on/off toggle switch; 4) SLOWLY turning the current strength rotary dial clockwise to the desired setting, at this time the red light should be flashing. Usually 5-10mA of current is sufficient, but 20 mA is a maximum. Based on the tocometer recordings the least amount of EI current is given to inhibit the uterine contractions.
arm group label: 120 Minute Study
arm group label: 60 Minute Study
arm group label: 80 Minute Study
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Karsdon, MD
role: Study Chair
affiliation: New York University Lagone Medical Center
last name: John Smulian, MD
role: Principal Investigator
affiliation: University of Florida
last name: John Smulian, MD
phone: 352-273-7580
email: jsmulian@ufl.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
citation: Karsdon J, El Daouk M, Huang WM, Ashmead GG. Electrical pacemaker as a safe and feasible method for decreasing the uterine contractions of human preterm labor. J Perinat Med. 2012 Nov;40(6):697-700. doi: 10.1515/jpm-2012-0136.
PMID: 23089601
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
sharing ipd: No