xml: <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/NCT05970874</url>
    </required_header>
    <id_info>
      <org_study_id>06-2022/10</org_study_id>
      <nct_id>NCT05970874</nct_id>
    </id_info>
    <brief_title>Evaluation of Hand Grip Strength in Pregnant COVID-19 Patients</brief_title>
    <official_title>Musculoskeletal Pain in Pregnant Infected With COVID-19, Evaluation of Fatigue and Muscle Grip Strength</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karaman Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karaman Training and Research Hospital</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>
        It was presented as a cross-sectional, single-center, retrospective case series. Pregnant&#xD;
        women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were included in&#xD;
        the study. The relationship between patients' musculoskeletal symptoms and signs and hand&#xD;
        grip strength was investigated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Covid 19 is the disease defined for strains infected with severe acute respiratory syndrome&#xD;
        coronavirus 2(Sars-CoV-2). Hand grip strength is a non-invasive, easily applicable, objective&#xD;
        parameter. It was presented as a cross-sectional, single-center, retrospective case series.&#xD;
        Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were&#xD;
        included in the study. The relationship between patients' musculoskeletal symptoms and signs&#xD;
        and hand grip strength was investigated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">May 30, 2022</completion_date>
    <primary_completion_date type="Actual">May 1, 2022</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Hand grip strength assessment</measure>
      <time_frame>The first 24 hours after admission to the service.</time_frame>
      <description>Hand grip strength assessment in pregnancy Covid 19.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>symptoms</measure>
      <time_frame>The first 24 hours after admission to the service.</time_frame>
      <description>Common symptoms of pregnant Covid 19 patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>laboratory findings</measure>
      <time_frame>The first 24 hours after admission to the service.</time_frame>
      <description>Common laboratory findings of pregnant Covid 19 patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaccine</measure>
      <time_frame>pre-infection period was questioned</time_frame>
      <description>Vaccine rate of pregnant Covid 19 patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Smoking</measure>
      <time_frame>pre-infection period was questioned</time_frame>
      <description>Smoking rate of pregnant Covid 19 patients.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">23</enrollment>
    <condition>COVID-19</condition>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>pregnant covid 19 patients</arm_group_label>
      <description>pregnant covid 19 patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hand grip strength measureme</intervention_name>
      <description>Hand grip strength (HSG) was measured in kg with the CAMRY Digital Hand Dynamometer (Model No. EH101, CAMRY).</description>
      <arm_group_label>pregnant covid 19 patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          pregnant covid 19 patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with orthopedic defects in the dominant hand and wrist and those with hand,&#xD;
               wrist and shoulder involvement on the side of the measurement related to&#xD;
               rheumatological diseases were excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hatice Toprak</last_name>
      <role>Principal Investigator</role>
      <affiliation>dr.tprk@hotmail.com</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hatice Toprak</name>
        <address>
          <city>Karaman</city>
          <state>Merkez</state>
          <zip>70200</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>Musculoskeletal Symptom</keyword>
    <keyword>Hand Grip Muscle Streng</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970874
  org study id: 06-2022/10
  nct id: NCT05970874
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It was presented as a cross-sectional, single-center, retrospective case series. Pregnant
        women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were included in
        the study. The relationship between patients' musculoskeletal symptoms and signs and hand
        grip strength was investigated.
  Covid 19 is the disease defined for strains infected with severe acute respiratory syndrome
        coronavirus 2(Sars-CoV-2). Hand grip strength is a non-invasive, easily applicable, objective
        parameter. It was presented as a cross-sectional, single-center, retrospective case series.
        Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were
        included in the study. The relationship between patients' musculoskeletal symptoms and signs
        and hand grip strength was investigated.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Hand grip strength assessment
  time frame: The first 24 hours after admission to the service.
  description: Hand grip strength assessment in pregnancy Covid 19.
  measure: symptoms
  time frame: The first 24 hours after admission to the service.
  description: Common symptoms of pregnant Covid 19 patients.
  measure: laboratory findings
  time frame: The first 24 hours after admission to the service.
  description: Common laboratory findings of pregnant Covid 19 patients.
  measure: Vaccine
  time frame: pre-infection period was questioned
  description: Vaccine rate of pregnant Covid 19 patients.
  measure: Smoking
  time frame: pre-infection period was questioned
  description: Smoking rate of pregnant Covid 19 patients.
  arm group label: pregnant covid 19 patients
  description: pregnant covid 19 patients
  intervention type: Device
  intervention name: Hand grip strength measureme
  description: Hand grip strength (HSG) was measured in kg with the CAMRY Digital Hand Dynamometer (Model No. EH101, CAMRY).
  arm group label: pregnant covid 19 patients
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Hatice Toprak
  role: Principal Investigator
  affiliation: dr.tprk@hotmail.com
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No