<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/NCT04437576</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00020328</org_study_id>
    <nct_id>NCT04437576</nct_id>
  </id_info>
  <brief_title>Pregnancy and Latent Labor Biomarkers and Symptoms to Predict Cervical Dilation at Hospital Admission.</brief_title>
  <official_title>Pregnancy and Latent Labor Biomarkers and Symptoms to Predict Cervical Dilation at Hospital Admission.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bloomlife Technologies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Foundation, Oregon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>OHSU School of Nursing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed pilot investigation is a prospective, observational study of 300 healthy&#xD;
      nulliparous women with spontaneous term labor onset. The specific aims of this study are to:&#xD;
&#xD;
      Aim #1: Characterize IL-8 (pro-inflammatory biomarker), basal body temperature, maternal&#xD;
      heart rate, and electrical activity of the uterus prior to spontaneous onset of labor through&#xD;
      the onset of active labor among nulliparous women. IL-8 will be quantified weekly, daily&#xD;
      basal body temperature, as well as continuous maternal heart rate and electrical activity of&#xD;
      the uterus throughout the transition from late pregnancy into active labor.&#xD;
&#xD;
      Aim #2: Characterize latent labor symptoms among nulliparous women in spontaneous labor.&#xD;
      Using Likert scale, childbirth-specific, symptom-specific PROMIS measures,45 and open-ended&#xD;
      questions will be quantified and characterize latent labor symptoms (e.g., intensity,&#xD;
      frequency) and identify relevant themes.&#xD;
&#xD;
      Aim #3: Characterize trajectories of labor biomarkers and latent labor symptoms across latent&#xD;
      labor duration. A modified growth mixture modeling approach to quantify subgroup phenotypes&#xD;
      among nulliparous women in spontaneous latent labor will be employed.&#xD;
&#xD;
      Hypothesis 3.1. There will be significant congruence between higher biomarkers (e.g., higher&#xD;
      IL-8, more uterine electrical activity) and symptoms that are more intense and frequent.&#xD;
&#xD;
      Hypothesis 3.2. At least two classes of laboring women with distinct trajectories of change&#xD;
      in biomarkers and symptoms can be identified and will be associated with cervical dilation at&#xD;
      hospital admission.&#xD;
&#xD;
      Exploratory Aim: Characterize biomarkers among nulliparous women with spontaneous labor onset&#xD;
      vs. nulliparous women requiring labor induction for post-term gestation. Weekly IL-8, daily&#xD;
      basal body temperature, as well as continuous maternal heart rate and electrical activity of&#xD;
      the uterus throughout the transition from late pregnancy into active labor between those&#xD;
      whose labor begins spontaneously and those whose labors are induced for post-term gestation&#xD;
      will be quantified.&#xD;
&#xD;
      Exploratory Hypothesis. There will be different biomarker patterns between women with&#xD;
      spontaneous labor onset vs. those without.&#xD;
&#xD;
      The Standard descriptive and inferential statistics as well as growth mixture modeling for&#xD;
      quantitative aims will be used. The investigators will use thematic development for&#xD;
      qualitative aims.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 13, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Change in Interleukin-8 (IL-8) expression during latent phase of labor to delivery</measure>
    <time_frame>week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU</time_frame>
    <description>Measure of IL-8 in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Basal body temperature during latent phase of labor to delivery</measure>
    <time_frame>Daily from 37 weeks gestation until admission to hospital for labor</time_frame>
    <description>Measure body temperature first thing every morning until admission to hospital for birth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maternal heart rate during latent phase of labor to delivery</measure>
    <time_frame>Continuously from 37 weeks gestation until admission to hospital for labor</time_frame>
    <description>Wearable sensor worn to record heart rate continually.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in electrical activity of the uterus during latent phase of labor to delivery</measure>
    <time_frame>Continuously from 37 weeks gestation until admission to hospital for labor</time_frame>
    <description>Wearable sensor that records signals detected on the surface of the abdomen (e.g. signals generated by the uterus) and movements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterize latent labor symptoms among nulliparous women in spontaneous labor</measure>
    <time_frame>week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU</time_frame>
    <description>Quantify and characterize latent labor symptoms and identify relevant themes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize trajectories of latent labor biomarkers across latent labor duration</measure>
    <time_frame>week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU</time_frame>
    <description>Quantify subgroup phenotypes among nulliparous women in spontaneous latent labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize trajectories of latent labor symptoms across latent labor duration</measure>
    <time_frame>week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU</time_frame>
    <description>Quantify subgroup phenotypes among nulliparous women in spontaneous latent labor using growth mixture modeling viewing longitudinal change.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Basal body temperature comparison in spontaneous labor vs induction</measure>
    <time_frame>week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU</time_frame>
    <description>Quantified weekly basal body temperature comparison throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in continuous maternal heart rate comparison in spontaneous labor vs induction</measure>
    <time_frame>week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU</time_frame>
    <description>Quantified maternal heart rate comparison throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in IL-8 comparison in spontaneous labor vs induction</measure>
    <time_frame>week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU</time_frame>
    <description>Quantified weekly IL-8 comparison throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation.</description>
  </other_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Labor Onset Biomarkers</condition>
  <condition>Labor Onset</condition>
  <condition>Cervical Dilation</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This is a study of reproductive age women 20-39 years of age being performed at Oregon&#xD;
        Health &amp; Science University (OHSU) in Portland, OR. It will include subjects who present&#xD;
        for prenatal care in our outpatient Center for Women's Health Clinics and OHSU Labor and&#xD;
        Delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Nulliparous&#xD;
&#xD;
          2. Maternal age of at least 20 years of age.&#xD;
&#xD;
          3. Maternal age of no greater than 39 years of age.&#xD;
&#xD;
          4. Viable, term pregnancy: ≥ 37 weeks gestation at time of signing study consent.&#xD;
&#xD;
          5. Able to understand and provide an informed consent.&#xD;
&#xD;
          6. Able to understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multiple gestation (i.e., carrying &gt;1 fetus)&#xD;
&#xD;
          2. Managing complex comorbidities (e.g., preeclampsia)&#xD;
&#xD;
          3. Documented fetal congenital anomalies&#xD;
&#xD;
          4. Preterm labor and birth&#xD;
&#xD;
          5. Persistent breech fetal position at term&#xD;
&#xD;
          6. Fetal death prior to the onset of labor&#xD;
&#xD;
          7. Any indication for planned cesarean birth (e.g., placenta previa)&#xD;
&#xD;
          8. Induction of labor for medical indication (e.g., oligohydramnios)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ellen Tilden, PhD, CNM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Ellen Tilden</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dilatation, Pathologic</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/NCT04437576
org study id: STUDY00020328
nct id: NCT04437576
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The proposed pilot investigation is a prospective, observational study of 300 healthy
      nulliparous women with spontaneous term labor onset. The specific aims of this study are to:

      Aim #1: Characterize IL-8 (pro-inflammatory biomarker), basal body temperature, maternal
      heart rate, and electrical activity of the uterus prior to spontaneous onset of labor through
      the onset of active labor among nulliparous women. IL-8 will be quantified weekly, daily
      basal body temperature, as well as continuous maternal heart rate and electrical activity of
      the uterus throughout the transition from late pregnancy into active labor.

      Aim #2: Characterize latent labor symptoms among nulliparous women in spontaneous labor.
      Using Likert scale, childbirth-specific, symptom-specific PROMIS measures,45 and open-ended
      questions will be quantified and characterize latent labor symptoms (e.g., intensity,
      frequency) and identify relevant themes.

      Aim #3: Characterize trajectories of labor biomarkers and latent labor symptoms across latent
      labor duration. A modified growth mixture modeling approach to quantify subgroup phenotypes
      among nulliparous women in spontaneous latent labor will be employed.

      Hypothesis 3.1. There will be significant congruence between higher biomarkers (e.g., higher
      IL-8, more uterine electrical activity) and symptoms that are more intense and frequent.

      Hypothesis 3.2. At least two classes of laboring women with distinct trajectories of change
      in biomarkers and symptoms can be identified and will be associated with cervical dilation at
      hospital admission.

      Exploratory Aim: Characterize biomarkers among nulliparous women with spontaneous labor onset
      vs. nulliparous women requiring labor induction for post-term gestation. Weekly IL-8, daily
      basal body temperature, as well as continuous maternal heart rate and electrical activity of
      the uterus throughout the transition from late pregnancy into active labor between those
      whose labor begins spontaneously and those whose labors are induced for post-term gestation
      will be quantified.

      Exploratory Hypothesis. There will be different biomarker patterns between women with
      spontaneous labor onset vs. those without.

      The Standard descriptive and inferential statistics as well as growth mixture modeling for
      quantitative aims will be used. The investigators will use thematic development for
      qualitative aims.
observational model: Cohort
time perspective: Prospective
measure: Change in Interleukin-8 (IL-8) expression during latent phase of labor to delivery
time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
description: Measure of IL-8 in serum
measure: Changes in Basal body temperature during latent phase of labor to delivery
time frame: Daily from 37 weeks gestation until admission to hospital for labor
description: Measure body temperature first thing every morning until admission to hospital for birth.
measure: Change in Maternal heart rate during latent phase of labor to delivery
time frame: Continuously from 37 weeks gestation until admission to hospital for labor
description: Wearable sensor worn to record heart rate continually.
measure: Change in electrical activity of the uterus during latent phase of labor to delivery
time frame: Continuously from 37 weeks gestation until admission to hospital for labor
description: Wearable sensor that records signals detected on the surface of the abdomen (e.g. signals generated by the uterus) and movements.
measure: Characterize latent labor symptoms among nulliparous women in spontaneous labor
time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
description: Quantify and characterize latent labor symptoms and identify relevant themes
measure: Characterize trajectories of latent labor biomarkers across latent labor duration
time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
description: Quantify subgroup phenotypes among nulliparous women in spontaneous latent labor
measure: Characterize trajectories of latent labor symptoms across latent labor duration
time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
description: Quantify subgroup phenotypes among nulliparous women in spontaneous latent labor using growth mixture modeling viewing longitudinal change.
measure: Change in Basal body temperature comparison in spontaneous labor vs induction
time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
description: Quantified weekly basal body temperature comparison throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation.
measure: Changes in continuous maternal heart rate comparison in spontaneous labor vs induction
time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
description: Quantified maternal heart rate comparison throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation.
measure: Changes in IL-8 comparison in spontaneous labor vs induction
time frame: week 37, week 38, week 39, week 40, week 41, week 42, upon admission for labor to OHSU
description: Quantified weekly IL-8 comparison throughout the transition from late pregnancy into active labor between those whose labor begins spontaneously and those whose labors are induced for post-term gestation.
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
last name: Ellen Tilden, PhD, CNM
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Ellen Tilden
investigator title: Assistant Professor
mesh term: Dilatation, Pathologic
sharing ipd: No