<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/NCT04482504</url>
  </required_header>
  <id_info>
    <org_study_id>EC/099/2019/UNBRuzinov</org_study_id>
    <nct_id>NCT04482504</nct_id>
  </id_info>
  <brief_title>Balance Disorders Related to Pregnancy</brief_title>
  <acronym>PRST</acronym>
  <official_title>Balance Disorders Related to Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Comenius University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Comenius University</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>
      Primary aim of this study is to evaluate postural equilibrium and risk of falls during&#xD;
      pregnancy by comparing static postural stability between pregnant and non-pregnant control&#xD;
      women. Secondary aim is to find out predisposing factors of falling during pregnancy using by&#xD;
      validated questionnaires focused on exercise activities and self-evaluation of postural&#xD;
      stability. The investigators also determine level of vitamin D in the blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several hormonal, anatomical and physiological changes occur in the female body during&#xD;
      pregnancy. These changes caused by pregnancy include significant weight gain, increased&#xD;
      ligamentous laxity and spinal lordosis, decreased neuromuscular control and abdominal muscle&#xD;
      strength, altered biomechanics and an anterior shift in the location of the centre of mass.&#xD;
      These alteration of pregnant woman body can lead to balance problems.&#xD;
&#xD;
      Falls during pregnancy are very common. Pregnant women especially in advanced stage of&#xD;
      pregnancy are at higher risk of falling compared to non-pregnant women. Falls during&#xD;
      pregnancy may cause maternal injuries such as bone fractures, joint sprains, muscle strains,&#xD;
      head injury, rupture of internal organs, abruptio placentae, rupture of the uterus and&#xD;
      membranes and occasionally maternal death or intrauterine fetal demise. Pregnant women are&#xD;
      hospitalized due to a fall 2,3 times more than non-pregnant reproductive-aged women.&#xD;
&#xD;
      There is few evidence in a literature about postural stability but not about risk factors,&#xD;
      that caused stability disorders. By determination of risk factors, the investigators can&#xD;
      reduce number of falls in pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</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>To determine differences of postural stability between pregnant and non-pregnant women.</measure>
    <time_frame>1 hour</time_frame>
    <description>To determine differences of postural stability between pregnant and non-pregnant women.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>find out predisposing factors of falling during pregnancy</measure>
    <time_frame>1 hour</time_frame>
    <description>Secondary aim is to find out predisposing factors of falling during pregnancy using by validated questionnaires focused on exercise activities and self-evaluation of postural stability.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">230</enrollment>
  <condition>Balance, Postural</condition>
  <condition>Fall</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>healthy pregnant women</arm_group_label>
    <description>200 healthy pregnant women in 36.-38. Week of pregnancy. The investigators involve every healthy pregnant woman in 36.-38. week of pregnancy.&#xD;
Exclusion criteria:&#xD;
Unwilling to participate&#xD;
Minors (under 18 years old)&#xD;
e) Unfamiliar with slovak language f) Multiple pregnancy g) Musculoskeletal and neurological abnormalities</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-pregnant women</arm_group_label>
    <description>30 non-pregnant healthy control women The investigators involve every healthy non-pregnant woman.&#xD;
Exclusion criteria:&#xD;
Unwilling to participate&#xD;
Minors (under 18 years old)&#xD;
e) Unfamiliar with slovak language f) Pregnancy g) Musculoskeletal and neurological abnormalities</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>3 tests: Posturography, Questionnaire, vitamin D</intervention_name>
    <description>Posturography platform Kistler 9281B Questionnaire focused on exercise activities and self-evaluation of postural stability The investigators also determine level of vitamin D in the blood.</description>
    <arm_group_label>healthy pregnant women</arm_group_label>
    <arm_group_label>non-pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant and non-pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The investigators involve every pregnant woman in 36.-38. week of pregnancy that&#xD;
             attending an outpatient clinic at 2nd Department of Obstetrics and Gynecology,&#xD;
             University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to participate&#xD;
&#xD;
          -  Minors (under 18 years old)&#xD;
&#xD;
          -  Musculoskeletal and neurological abnormalities&#xD;
&#xD;
          -  Unfamiliar with slovak language&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregrancy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic</name>
      <address>
        <city>Bratislava</city>
        <state>Slovensko</state>
        <zip>83232</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovakia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>static posturography</keyword>
  <keyword>Fall</keyword>
  <keyword>pregnancy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not yet setup.</ipd_description>
  </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/NCT04482504
org study id: EC/099/2019/UNBRuzinov
nct id: NCT04482504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary aim of this study is to evaluate postural equilibrium and risk of falls during
      pregnancy by comparing static postural stability between pregnant and non-pregnant control
      women. Secondary aim is to find out predisposing factors of falling during pregnancy using by
      validated questionnaires focused on exercise activities and self-evaluation of postural
      stability. The investigators also determine level of vitamin D in the blood.
Several hormonal, anatomical and physiological changes occur in the female body during
      pregnancy. These changes caused by pregnancy include significant weight gain, increased
      ligamentous laxity and spinal lordosis, decreased neuromuscular control and abdominal muscle
      strength, altered biomechanics and an anterior shift in the location of the centre of mass.
      These alteration of pregnant woman body can lead to balance problems.

      Falls during pregnancy are very common. Pregnant women especially in advanced stage of
      pregnancy are at higher risk of falling compared to non-pregnant women. Falls during
      pregnancy may cause maternal injuries such as bone fractures, joint sprains, muscle strains,
      head injury, rupture of internal organs, abruptio placentae, rupture of the uterus and
      membranes and occasionally maternal death or intrauterine fetal demise. Pregnant women are
      hospitalized due to a fall 2,3 times more than non-pregnant reproductive-aged women.

      There is few evidence in a literature about postural stability but not about risk factors,
      that caused stability disorders. By determination of risk factors, the investigators can
      reduce number of falls in pregnancy.
observational model: Cohort
time perspective: Prospective
measure: To determine differences of postural stability between pregnant and non-pregnant women.
time frame: 1 hour
description: To determine differences of postural stability between pregnant and non-pregnant women.
measure: find out predisposing factors of falling during pregnancy
time frame: 1 hour
description: Secondary aim is to find out predisposing factors of falling during pregnancy using by validated questionnaires focused on exercise activities and self-evaluation of postural stability.
arm group label: healthy pregnant women
description: 200 healthy pregnant women in 36.-38. Week of pregnancy. The investigators involve every healthy pregnant woman in 36.-38. week of pregnancy.
Exclusion criteria:
Unwilling to participate
Minors (under 18 years old)
e) Unfamiliar with slovak language f) Multiple pregnancy g) Musculoskeletal and neurological abnormalities
arm group label: non-pregnant women
description: 30 non-pregnant healthy control women The investigators involve every healthy non-pregnant woman.
Exclusion criteria:
Unwilling to participate
Minors (under 18 years old)
e) Unfamiliar with slovak language f) Pregnancy g) Musculoskeletal and neurological abnormalities
intervention type: Diagnostic Test
intervention name: 3 tests: Posturography, Questionnaire, vitamin D
description: Posturography platform Kistler 9281B Questionnaire focused on exercise activities and self-evaluation of postural stability The investigators also determine level of vitamin D in the blood.
arm group label: healthy pregnant women
arm group label: non-pregnant women
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregrancy
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Slovakia
responsible party type: Sponsor
mesh term: Vitamin D
sharing ipd: Undecided
ipd description: Not yet setup.