<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/NCT04418557</url>
  </required_header>
  <id_info>
    <org_study_id>20200479</org_study_id>
    <nct_id>NCT04418557</nct_id>
  </id_info>
  <brief_title>COVID-19 and Obstetric Transmission</brief_title>
  <acronym>COVIDOB</acronym>
  <official_title>COVID-19 and Obstetric Transmission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cuyahoga County Board of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MetroHealth Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to capture data, laboratory markers, and clinical outcomes of&#xD;
      obstetric and neonatal outcomes in cases of COVID-19 during pregnancy and of pregnancies&#xD;
      exposed to a COVID-19 vaccine in Cuyahoga County.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A review of the 55 cases of obstetric COVID-19 cases world-wide demonstrate the following&#xD;
      fetal complications of COVID-19: miscarriage (2%), intrauterine growth restriction (IUGR;&#xD;
      10%), pre-eclampsia, and pre-term birth (39%). In Wuhan, China, nine women who were COVID-19&#xD;
      positive were surveilled for vertical transmission and overall obstetric and early neonatal&#xD;
      outcomes. Amniotic fluid, umbilical cord blood, and neonatal throat swabs were collected at&#xD;
      the time of delivery, and breastmilk samples were collected after lactation commenced. There&#xD;
      was no viral detection of COVID-19 demonstrated.2 However, two neonates in the United Kingdom&#xD;
      have tested positively for COVID-19 after delivery from an infected mother. Most recently,&#xD;
      antibodies were detected (IgM and IgG) in the serum of a neonate born via cesarean delivery&#xD;
      to a known positive mother. Therefore, vertical transmission has not been completely ruled&#xD;
      out.&#xD;
&#xD;
      Additionally, infection at varying times of pregnancy has not been well delineated or&#xD;
      correlated to neonatal or maternal outcomes at time of delivery. Therefore, there is a need&#xD;
      to continue surveying and documenting clinical findings in obstetric COVID-19 cases.&#xD;
&#xD;
      This study will follow pregnant women who are diagnosed during any point of their pregnancy&#xD;
      with COVID-19 and those who were vaccinated. during pregnancy. The aim will be to evaluate&#xD;
      maternal and neonatal specimens for the presence of COVID-19 virus, immune and cellular&#xD;
      response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Actual">July 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 15, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Presence of COVID-19 virus</measure>
    <time_frame>At time of delivery</time_frame>
    <description>Viral presence in any of the collected specimens</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of antibodies to COVID-19 virus</measure>
    <time_frame>At time of delivery and 24 hours of life of the newborn</time_frame>
    <description>Antibodies detected in any of the collected specimens</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Immune responses to COVID-19 virus What is the Immune responses of a mother infected with COVID-19 and neonates? What is the Immune responses of a mother infected with COVID-19 and neonates? Immune response to COVID-19 virus</measure>
    <time_frame>At time of delivery and 24 hours of life of the newborn</time_frame>
    <description>Innate/Adaptive cell function and immune response</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">64</enrollment>
  <condition>COVID</condition>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Pregnant women without COVID-19 Infection</arm_group_label>
    <description>Women who are tested for COVID-19 at the time of admission for labor and delivery and test negative</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant women with a history of COVID-19 infection</arm_group_label>
    <description>Women who are tested for COVID-19 at any point during their pregnancy, including at the time of admission for labor and delivery, and test positive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant women vaccinated for COVID-19</arm_group_label>
    <description>Women who are vaccinated against COVID-19 at any point during their pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>RT-PCR and antibody testing</intervention_name>
    <description>Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.</description>
    <arm_group_label>Pregnant women with a history of COVID-19 infection</arm_group_label>
    <arm_group_label>Pregnant women without COVID-19 Infection</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal blood, neonatal blood, amniotic fluid, amnion, chorion, umbilical cord, vaginal&#xD;
      secretion, cord blood, newborn throat swab, breastmilk&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who have been diagnosed with COVID-19 at any point of their pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 infection at any time of the pregnancy, or presumed case by symptoms and&#xD;
             direct contact with a positive case&#xD;
&#xD;
          -  Pregnancy documented by ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COVID-19 infection before or after pregnancy&#xD;
&#xD;
          -  Person under investigation, but not a presumed or known positive case&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>must be pregnant</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospitals 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>
  <results_reference>
    <citation>Dong L, Tian J, He S, Zhu C, Wang J, Liu C, Yang J. Possible Vertical Transmission of SARS-CoV-2 From an Infected Mother to Her Newborn. JAMA. 2020 May 12;323(18):1846-1848. doi: 10.1001/jama.2020.4621.</citation>
    <PMID>32215581</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32151335</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</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>Rachel Pope</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>Pregnancy Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_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/NCT04418557
org study id: 20200479
nct id: NCT04418557
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to capture data, laboratory markers, and clinical outcomes of
      obstetric and neonatal outcomes in cases of COVID-19 during pregnancy and of pregnancies
      exposed to a COVID-19 vaccine in Cuyahoga County.
A review of the 55 cases of obstetric COVID-19 cases world-wide demonstrate the following
      fetal complications of COVID-19: miscarriage (2%), intrauterine growth restriction (IUGR;
      10%), pre-eclampsia, and pre-term birth (39%). In Wuhan, China, nine women who were COVID-19
      positive were surveilled for vertical transmission and overall obstetric and early neonatal
      outcomes. Amniotic fluid, umbilical cord blood, and neonatal throat swabs were collected at
      the time of delivery, and breastmilk samples were collected after lactation commenced. There
      was no viral detection of COVID-19 demonstrated.2 However, two neonates in the United Kingdom
      have tested positively for COVID-19 after delivery from an infected mother. Most recently,
      antibodies were detected (IgM and IgG) in the serum of a neonate born via cesarean delivery
      to a known positive mother. Therefore, vertical transmission has not been completely ruled
      out.

      Additionally, infection at varying times of pregnancy has not been well delineated or
      correlated to neonatal or maternal outcomes at time of delivery. Therefore, there is a need
      to continue surveying and documenting clinical findings in obstetric COVID-19 cases.

      This study will follow pregnant women who are diagnosed during any point of their pregnancy
      with COVID-19 and those who were vaccinated. during pregnancy. The aim will be to evaluate
      maternal and neonatal specimens for the presence of COVID-19 virus, immune and cellular
      response.
observational model: Case-Control
time perspective: Prospective
measure: Presence of COVID-19 virus
time frame: At time of delivery
description: Viral presence in any of the collected specimens
measure: Presence of antibodies to COVID-19 virus
time frame: At time of delivery and 24 hours of life of the newborn
description: Antibodies detected in any of the collected specimens
measure: Immune responses to COVID-19 virus What is the Immune responses of a mother infected with COVID-19 and neonates? What is the Immune responses of a mother infected with COVID-19 and neonates? Immune response to COVID-19 virus
time frame: At time of delivery and 24 hours of life of the newborn
description: Innate/Adaptive cell function and immune response
arm group label: Pregnant women without COVID-19 Infection
description: Women who are tested for COVID-19 at the time of admission for labor and delivery and test negative
arm group label: Pregnant women with a history of COVID-19 infection
description: Women who are tested for COVID-19 at any point during their pregnancy, including at the time of admission for labor and delivery, and test positive
arm group label: Pregnant women vaccinated for COVID-19
description: Women who are vaccinated against COVID-19 at any point during their pregnancy
intervention type: Diagnostic Test
intervention name: RT-PCR and antibody testing
description: Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.
arm group label: Pregnant women with a history of COVID-19 infection
arm group label: Pregnant women without COVID-19 Infection
Maternal blood, neonatal blood, amniotic fluid, amnion, chorion, umbilical cord, vaginal
      secretion, cord blood, newborn throat swab, breastmilk
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: must be pregnant
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Dong L, Tian J, He S, Zhu C, Wang J, Liu C, Yang J. Possible Vertical Transmission of SARS-CoV-2 From an Infected Mother to Her Newborn. JAMA. 2020 May 12;323(18):1846-1848. doi: 10.1001/jama.2020.4621.
PMID: 32215581
citation: Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, Li J, Zhao D, Xu D, Gong Q, Liao J, Yang H, Hou W, Zhang Y. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020 Mar 7;395(10226):809-815. doi: 10.1016/S0140-6736(20)30360-3. Epub 2020 Feb 12. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32151335
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Rachel Pope
investigator title: Assistant Professor
mesh term: Pregnancy Complications
mesh term: Antibodies
sharing ipd: No