<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/NCT04433364</url>
  </required_header>
  <id_info>
    <org_study_id>2020-02848 0604</org_study_id>
    <nct_id>NCT04433364</nct_id>
  </id_info>
  <brief_title>COPE - COVID-19 in Pregnancy and Early Childhood</brief_title>
  <acronym>COPE</acronym>
  <official_title>COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</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>
      Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human&#xD;
      race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both&#xD;
      for individual human lives as well as for the society and the health care sector. The&#xD;
      knowledge on how this new infection affects both the mother and the unborn child as well as&#xD;
      the outcomes for the mother and the child in the long run are unknown. What is known is based&#xD;
      on case-reports and small case-series solely. Both the coronaviruses causing Middle East&#xD;
      Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat&#xD;
      to pregnant women and their offspring, which leads to the question whether this could be the&#xD;
      case also for SARS-CoV-2.&#xD;
&#xD;
      Aims: To establish a biobank of biological material from infected as well as non-infected&#xD;
      pregnant women and their offspring. To combine this biobank with Swedish quality and health&#xD;
      care registers, computerized patient charts and questionnaire data, enabling both short-term&#xD;
      follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and&#xD;
      child. To study how the pandemic situation affects both the mother and her partner in their&#xD;
      experience of pregnancy, childbirth, and early parenthood.&#xD;
&#xD;
      Design: A national Swedish multicentre study. Women are included when they have a positive&#xD;
      test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19&#xD;
      group). Pregnant women without COVID-19 symptoms will be included at their routine visits&#xD;
      (Screening group). Blood samples and other biological material will be collected at different&#xD;
      time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy&#xD;
      Register as well as obligatory Swedish health registers. The biobank and its linkage to&#xD;
      health registers through the Swedish personal identification number will enable future&#xD;
      research. Child development will be followed during the first year of life by questionnaires&#xD;
      to the parents. Womens' and their partners' experience of childbirth and parenthood will be&#xD;
      studied in form of questionnaires as well as in form of interviews.&#xD;
&#xD;
      Conclusion: This project will help obstetricians and neonatologists better recognize clinical&#xD;
      manifestations of the virus, identify possible risk factors during pregnancy and tailor&#xD;
      therapies alongside providing right level of surveillance and management during pregnancy,&#xD;
      delivery, and child health care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">June 2, 2041</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>20 Years</target_duration>
  <primary_outcome>
    <measure>Biobank with linkage to registers</measure>
    <time_frame>1-20 years</time_frame>
    <description>establish a biobank and database with bio-samples from both women that are not tested and presumed healthy as well as possibly ill and women confirmed tested positive for SARS-CoV-2 and their infants linked to Swedish health care registers including socio-economic factors and use serological and viral analyses from the biological samples to evaluate maternal, fetal and neonatal outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Experiences of pregnancy during a pandemic</measure>
    <time_frame>1 year</time_frame>
    <description>study how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19-pandemic, both for women not tested and for women tested positive for SARS-CoV-2.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3834</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Covid-19</condition>
  <condition>Pregnancy Complications</condition>
  <condition>Pregnancy Preterm</condition>
  <condition>Pregnancy in Diabetic</condition>
  <condition>Neonatal Infection</condition>
  <arm_group>
    <arm_group_label>Screening group</arm_group_label>
    <description>a general population of women giving birth, called &quot;screening group&quot; included at routine antenatal visits, their partners, and children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 group</arm_group_label>
    <description>group of women testing positive for SARS-CoV-2 or falling ill with COVID-19, called &quot;COVID-19 group&quot;, their partners, and children</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biological samples, questionnaires and interviews</intervention_name>
    <description>Biological samples: to study impact of testing positive for SARS-CoV-2 during pregnancy samples taken in routine clinical care, samples from already existing research biobanks and the newly established COPE biobank will be used. Time-points: inclusion, at delivery mother and fetus. Covid-19 positive group only: 48-96 h, 2 months postpartum for mother and fetus.&#xD;
Questionnaires: Women and partners in both groups will fill out electronical questionnaires at different time points during pregnancy and until 12 months postpartum based on validated instruments to test for differences in Self-Efficacy, Anxiety and Depression, Health-related quality of life, Sense of Coherence, PTSD Symptoms, Postpartum Bonding, Childbirth experiences and Self-Efficacy of Breastfeeding. The child's health will be assessed regarding infection until 6 weeks of age and development until 4 years.&#xD;
Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth.</description>
    <arm_group_label>COVID-19 group</arm_group_label>
    <arm_group_label>Screening group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bloodsample from the mother antenatally, at inclusion and at delivery from healthy women, as&#xD;
      well as NPH-swab and placenta at delivery. Naval cord blood from healthy infants. From&#xD;
      covid-19 pos women: blood sample antenatally and at diagnosis as well as vaginal, rectal and&#xD;
      NPH swab and urinary sample. At delivery NPH-swabs as well as vaginal and rectal swabs and&#xD;
      urinary samples and blood and in case of caesarean section amnion fluid and spinal fluid.&#xD;
      Breastmilk at 48-96 hours after delivery. From the infant naval cord blood and at 48-96 hours&#xD;
      after delivery NPH-swab and rectal swab as well as blood sample. For the COVID-19 group a&#xD;
      follow-up visit during the first year after delivery for bloodsamples of mother and&#xD;
      child/children.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        18 years of age and above. Attending routine antenatal visits at a participating hospital&#xD;
        during the study period or are strongly suspicious of or diagnosed with Covid-19 during&#xD;
        pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women 18 years of age and above&#xD;
&#xD;
          -  Attending routine antenatal visits at a participating hospital during the study period&#xD;
             or are strongly suspicious of or diagnosed with Covid-19 during pregnancy.&#xD;
&#xD;
          -  For the questionnaire part: language knowledge (Swedish, English, Arabic, Somali)&#xD;
&#xD;
          -  For the interview part: Swedish language knowledge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Another language but selected ones&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Verena Sengpiel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Falu Hospital</name>
      <address>
        <city>Falun</city>
        <state>Dalarna</state>
        <zip>79182</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Halmstad lasarett</name>
      <address>
        <city>Halmstad</city>
        <state>Halland</state>
        <zip>30233</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Varbergs sjukhus</name>
      <address>
        <city>Varberg</city>
        <state>Halland</state>
        <zip>43237</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsingborgs lasarett</name>
      <address>
        <city>Helsingborg</city>
        <state>Skåne</state>
        <zip>25223</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skåne Universitetssjukhus</name>
      <address>
        <city>Lund</city>
        <state>Skåne</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eskiltuna hospital</name>
      <address>
        <city>Eskilstuna</city>
        <state>Södermanland</state>
        <zip>63003</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boras hospital</name>
      <address>
        <city>Boras</city>
        <state>VGR</state>
        <zip>50182</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Univeristy Hospital</name>
      <address>
        <city>Gothenburg</city>
        <state>VGR</state>
        <zip>41685</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryhovs sjukhus</name>
      <address>
        <city>Jönköping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kalmar Lasarett</name>
      <address>
        <city>Kalmar</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karlstad lasarett</name>
      <address>
        <city>Karlstad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kristiandstad länssjukhus</name>
      <address>
        <city>Kristianstad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skaraborgs sjukhus Skövde</name>
      <address>
        <city>Skövde</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BB Stockholm</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danderyd</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital Solna</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital- Huddinge</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Södersjukhuset</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Södertälje</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sundsvall</name>
      <address>
        <city>Sundsvall</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umeå University Hospital</name>
      <address>
        <city>Umeå</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Västerås</name>
      <address>
        <city>Västerås</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ystad</name>
      <address>
        <city>Ystad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Örebro University Hospital</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linköping University Hospital</name>
      <address>
        <city>Linköping</city>
        <state>Östergötland</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vrinnevisjukhuset</name>
      <address>
        <city>Norrköping</city>
        <state>Östergötland</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Verena Sengpiel</investigator_full_name>
    <investigator_title>MD, PhD, Senior Consultant</investigator_title>
  </responsible_party>
  <keyword>sars-cov2</keyword>
  <keyword>covid-19</keyword>
  <keyword>pregnancy</keyword>
  <keyword>neonatal</keyword>
  <keyword>long-term follow-up</keyword>
  <keyword>complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Outcome variables</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>2024</ipd_time_frame>
    <ipd_access_criteria>Ethical permission</ipd_access_criteria>
    <ipd_url>http://www.copestudien.se</ipd_url>
  </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/NCT04433364
org study id: 2020-02848 0604
nct id: NCT04433364
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human
      race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both
      for individual human lives as well as for the society and the health care sector. The
      knowledge on how this new infection affects both the mother and the unborn child as well as
      the outcomes for the mother and the child in the long run are unknown. What is known is based
      on case-reports and small case-series solely. Both the coronaviruses causing Middle East
      Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat
      to pregnant women and their offspring, which leads to the question whether this could be the
      case also for SARS-CoV-2.

      Aims: To establish a biobank of biological material from infected as well as non-infected
      pregnant women and their offspring. To combine this biobank with Swedish quality and health
      care registers, computerized patient charts and questionnaire data, enabling both short-term
      follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and
      child. To study how the pandemic situation affects both the mother and her partner in their
      experience of pregnancy, childbirth, and early parenthood.

      Design: A national Swedish multicentre study. Women are included when they have a positive
      test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19
      group). Pregnant women without COVID-19 symptoms will be included at their routine visits
      (Screening group). Blood samples and other biological material will be collected at different
      time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy
      Register as well as obligatory Swedish health registers. The biobank and its linkage to
      health registers through the Swedish personal identification number will enable future
      research. Child development will be followed during the first year of life by questionnaires
      to the parents. Womens' and their partners' experience of childbirth and parenthood will be
      studied in form of questionnaires as well as in form of interviews.

      Conclusion: This project will help obstetricians and neonatologists better recognize clinical
      manifestations of the virus, identify possible risk factors during pregnancy and tailor
      therapies alongside providing right level of surveillance and management during pregnancy,
      delivery, and child health care.
observational model: Cohort
time perspective: Prospective
measure: Biobank with linkage to registers
time frame: 1-20 years
description: establish a biobank and database with bio-samples from both women that are not tested and presumed healthy as well as possibly ill and women confirmed tested positive for SARS-CoV-2 and their infants linked to Swedish health care registers including socio-economic factors and use serological and viral analyses from the biological samples to evaluate maternal, fetal and neonatal outcomes.
measure: Experiences of pregnancy during a pandemic
time frame: 1 year
description: study how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19-pandemic, both for women not tested and for women tested positive for SARS-CoV-2.
arm group label: Screening group
description: a general population of women giving birth, called "screening group" included at routine antenatal visits, their partners, and children
arm group label: COVID-19 group
description: group of women testing positive for SARS-CoV-2 or falling ill with COVID-19, called "COVID-19 group", their partners, and children
intervention type: Other
intervention name: biological samples, questionnaires and interviews
description: Biological samples: to study impact of testing positive for SARS-CoV-2 during pregnancy samples taken in routine clinical care, samples from already existing research biobanks and the newly established COPE biobank will be used. Time-points: inclusion, at delivery mother and fetus. Covid-19 positive group only: 48-96 h, 2 months postpartum for mother and fetus.
Questionnaires: Women and partners in both groups will fill out electronical questionnaires at different time points during pregnancy and until 12 months postpartum based on validated instruments to test for differences in Self-Efficacy, Anxiety and Depression, Health-related quality of life, Sense of Coherence, PTSD Symptoms, Postpartum Bonding, Childbirth experiences and Self-Efficacy of Breastfeeding. The child's health will be assessed regarding infection until 6 weeks of age and development until 4 years.
Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth.
arm group label: COVID-19 group
arm group label: Screening group
Bloodsample from the mother antenatally, at inclusion and at delivery from healthy women, as
      well as NPH-swab and placenta at delivery. Naval cord blood from healthy infants. From
      covid-19 pos women: blood sample antenatally and at diagnosis as well as vaginal, rectal and
      NPH swab and urinary sample. At delivery NPH-swabs as well as vaginal and rectal swabs and
      urinary samples and blood and in case of caesarean section amnion fluid and spinal fluid.
      Breastmilk at 48-96 hours after delivery. From the infant naval cord blood and at 48-96 hours
      after delivery NPH-swab and rectal swab as well as blood sample. For the COVID-19 group a
      follow-up visit during the first year after delivery for bloodsamples of mother and
      child/children.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Verena Sengpiel, MD, PhD
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Sweden
facility: 
facility: 
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country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Verena Sengpiel
investigator title: MD, PhD, Senior Consultant
mesh term: COVID-19
mesh term: Pregnancy Complications
mesh term: Pregnancy in Diabetics
sharing ipd: Yes
ipd description: Outcome variables
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: 2024
ipd access criteria: Ethical permission
ipd url: http://www.copestudien.se