<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/NCT03772080</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20180789</org_study_id>
    <nct_id>NCT03772080</nct_id>
  </id_info>
  <brief_title>Prematurity Education in High Risk Pregnancies</brief_title>
  <official_title>Early Education of Prematurity in High Risk Pregnancies-A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rainbow Babies and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prematurity is associated with significant morbidity and mortality. Given the high risk of&#xD;
      death and disability, it is important for parents to understand the complications of&#xD;
      prematurity so they can make decisions for their child. Unfortunately, these discussions&#xD;
      often occur in the acute setting of threatened preterm labor when stress and anxiety make&#xD;
      comprehension difficult. This study aims to improve parental understanding by providing early&#xD;
      education of prematurity in the clinic setting for patients at high risk of preterm delivery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parental knowledge of prematurity.</measure>
    <time_frame>Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.</time_frame>
    <description>Questionnaire to assess parental knowledge regarding basic concepts of prematurity, associated complications and factors that improve survival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental satisfaction with prematurity education.</measure>
    <time_frame>Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.</time_frame>
    <description>Survey to assess usefulness of web-based educational tool and satisfaction with early education of prematurity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental anxiety.</measure>
    <time_frame>Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.</time_frame>
    <description>Evaluation of parental anxiety associated with prematurity using validated six-item short-form of the Spielberger State-Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory (STAI) measures presence and severity of anxiety. The inventory consists of two self-reporting subscales that evaluate the current state of anxiety (state anxiety subscale), as well as the propensity towards being anxious (trait anxiety subscale). The range for total score is 20-80, with a higher score indicating greater anxiety. The six-item version of the Spielberger State-Trait Anxiety Inventory (STAI: Y-6 item) is composed of three-questions from the original state anxiety subscale and three-questions from the original trait anxiety subscale. This shortened six-item inventory is a reliable and valid instrument when compared to the full forty-question inventory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal compliance with maternal-fetal medicine provider follow up.</measure>
    <time_frame>Outcome will be assessed up to 9 months following completion of the counseling intervention. Data will be analyzed and reported at the completion of the study.</time_frame>
    <description>Frequency of no show and cancelled appointments during remainder of pregnancy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Prematurity</condition>
  <condition>High Risk Pregnancy</condition>
  <arm_group>
    <arm_group_label>Early counseling of prematurity in high-risk pregnancies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard counseling of prematurity in high-risk pregnancies</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early counseling of prematurity in high-risk pregnancies.</intervention_name>
    <description>Standardized information regarding prematurity, including associated complications and ways to decrease chances of preterm birth using web-based educational platform.</description>
    <arm_group_label>Early counseling of prematurity in high-risk pregnancies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for&#xD;
             premature delivery.&#xD;
&#xD;
               1. Premature delivery defined as &lt;37 0/7 weeks gestation.&#xD;
&#xD;
               2. Any pregnant woman seen in the Maternal-Fetal Medicine Clinic deemed to be at&#xD;
                  high risk for premature delivery.&#xD;
&#xD;
          2. Pregnant women 16 years and older.&#xD;
&#xD;
          3. Pregnancy with singleton or twin gestation.&#xD;
&#xD;
          4. No major congenital malformation.&#xD;
&#xD;
          5. Women who are English speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women &lt;22 0/7 or &gt;35 0/7 weeks gestational age.&#xD;
&#xD;
          2. Pregnant women less than 16 years old.&#xD;
&#xD;
          3. Multiple gestation greater than twins (triplets, quadruplets, etc).&#xD;
&#xD;
          4. Known major congenital malformation.&#xD;
&#xD;
          5. Women who are non-English speaking.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca A Fish, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH, Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UH Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</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>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Rebecca Fish</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Antenatal Counseling</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT03772080
org study id: STUDY20180789
nct id: NCT03772080
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prematurity is associated with significant morbidity and mortality. Given the high risk of
      death and disability, it is important for parents to understand the complications of
      prematurity so they can make decisions for their child. Unfortunately, these discussions
      often occur in the acute setting of threatened preterm labor when stress and anxiety make
      comprehension difficult. This study aims to improve parental understanding by providing early
      education of prematurity in the clinic setting for patients at high risk of preterm delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Parental knowledge of prematurity.
time frame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
description: Questionnaire to assess parental knowledge regarding basic concepts of prematurity, associated complications and factors that improve survival.
measure: Parental satisfaction with prematurity education.
time frame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
description: Survey to assess usefulness of web-based educational tool and satisfaction with early education of prematurity.
measure: Parental anxiety.
time frame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
description: Evaluation of parental anxiety associated with prematurity using validated six-item short-form of the Spielberger State-Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory (STAI) measures presence and severity of anxiety. The inventory consists of two self-reporting subscales that evaluate the current state of anxiety (state anxiety subscale), as well as the propensity towards being anxious (trait anxiety subscale). The range for total score is 20-80, with a higher score indicating greater anxiety. The six-item version of the Spielberger State-Trait Anxiety Inventory (STAI: Y-6 item) is composed of three-questions from the original state anxiety subscale and three-questions from the original trait anxiety subscale. This shortened six-item inventory is a reliable and valid instrument when compared to the full forty-question inventory.
measure: Maternal compliance with maternal-fetal medicine provider follow up.
time frame: Outcome will be assessed up to 9 months following completion of the counseling intervention. Data will be analyzed and reported at the completion of the study.
description: Frequency of no show and cancelled appointments during remainder of pregnancy.
arm group label: Early counseling of prematurity in high-risk pregnancies
arm group type: Experimental
arm group label: Standard counseling of prematurity in high-risk pregnancies
arm group type: No Intervention
intervention type: Other
intervention name: Early counseling of prematurity in high-risk pregnancies.
description: Standardized information regarding prematurity, including associated complications and ways to decrease chances of preterm birth using web-based educational platform.
arm group label: Early counseling of prematurity in high-risk pregnancies
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca A Fish, MD
role: Principal Investigator
affiliation: UH, Cleveland Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Rebecca Fish
investigator title: Principal Investigator
mesh term: Premature Birth
sharing ipd: No