<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/NCT03277807</url>
  </required_header>
  <id_info>
    <org_study_id>EK 24-245 ex 11/12</org_study_id>
    <nct_id>NCT03277807</nct_id>
  </id_info>
  <brief_title>Physical Activity in Pregnancy</brief_title>
  <acronym>PAP</acronym>
  <official_title>Effect of Physical Activity in Pregnancy on Low Grade Inflammation: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</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>
      This prospective observational study assesses whether women who regularly exercise during&#xD;
      pregnancy show reduced low grade Inflammation, compared to women who are not regularly&#xD;
      exercising. Furthermore, the effects of regular physical activity in pregnancy on fetal and&#xD;
      neonatal outcomes will be investigated. 3 groups of pregnant women will be formed (group 1:&#xD;
      regularly physically active women; group 2: physically inactive women and group 3: women with&#xD;
      a history of preeclampsia or positive history of metabolic conditions increasing the risk of&#xD;
      hypertensive disorders in pregnancy).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnancy is a natural state of low grade inflammation in the mother and the feto-placental&#xD;
      unit. The severity of this inflammation increases with higher pregravid Body Mass Index&#xD;
      (BMI). This is reflected by an increase in pro-inflammatory cytokines in the maternal&#xD;
      circulation and in the placenta. It has been proposed that the pro-inflammatory maternal and&#xD;
      fetal environment plays a role in mediating pregnancy outcomes.&#xD;
&#xD;
      In non-pregnant individuals regular physical activity is associated with a reduced&#xD;
      inflammatory state. The overall objective of the study is to investigate the interaction of&#xD;
      maternal physical activity and pregnancy induced low-grade inflammation in the mother and&#xD;
      feto-placental unit, and to assess th resulting effects on prenatal and postnatal&#xD;
      development.&#xD;
&#xD;
      Specific research objective will be to study effects of maternal physical activity on:&#xD;
&#xD;
        1. low grade Inflammation in the mother an feto-placental unit;&#xD;
&#xD;
        2. maternal and fetal lipid profiles, including High Density Lipoprotein (HDL) proteome;&#xD;
&#xD;
        3. fetal growth and infant body composition;&#xD;
&#xD;
        4. transcriptomic and epigenetic profile in the placenta;&#xD;
&#xD;
        5. biomarkers of nutritive status;&#xD;
&#xD;
        6. psychological assessment: cardiac awareness; assessment of arterial stiffness;&#xD;
           stress-coping questionaire&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2013</start_date>
  <completion_date type="Actual">October 11, 2013</completion_date>
  <primary_completion_date type="Actual">October 11, 2013</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>low grade inflammation (in maternal and cord blood)</measure>
    <time_frame>1 year</time_frame>
    <description>clinical inflammation markers: C-reactive protein, cytokines and chemokine (IL1b, IL1a, IL-2, IL-5, IL-6,IL-12, TNFa, MCP-1, MIP1-a) measured by ELISA and multiplexing arrays</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>maternal and fetal (cord blood) lipid profiles</measure>
    <time_frame>1 year</time_frame>
    <description>triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neonatal body composition (% body fat)</measure>
    <time_frame>1 year</time_frame>
    <description>measured by air displacement plethysmography (Peapod)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal and newborn fat distribution</measure>
    <time_frame>1 year</time_frame>
    <description>subcutaneous adipose tissue thickness at 15 defined body sites, measured by a lipometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal growth</measure>
    <time_frame>1 year</time_frame>
    <description>measured by ultrasound scanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transcriptome of the placenta</measure>
    <time_frame>2 years</time_frame>
    <description>measured by full genome arrays</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>epigenetic analysis of the placenta</measure>
    <time_frame>2 years</time_frame>
    <description>analysed by 450k methylation arrays</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>biomarkers of nutritional status</measure>
    <time_frame>2 years</time_frame>
    <description>measurement of blood levels of fatty acids (DHA, EPA, 15:0, 17:0), vitamin A, B1, B2, B6, D2/D3, C, E, homocysteine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychological assessment</measure>
    <time_frame>1 year</time_frame>
    <description>assessment of arterial stiffness, stress coping questionnaire, cardiac awareness</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Pregnancy, Physical Activity</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <description>pregnant women who are physically active (spend a minimum of 150min/week with moderate to vigorous physical activity)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactive</arm_group_label>
    <description>pregnant women who are physically inactive (spend less than 150min/week with moderate to vigorous physical activity)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>risk for hypertensive disorders</arm_group_label>
    <description>pregnant women with a history of preeclampsia or positive history for metabolic conditions increasing the risk of hypertensive disorders in pregnancy</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      maternal venous blood (serum /plasma), cord blood (serum /plasma); placenta tissue (RNA&#xD;
      later);&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women with an ongoing healthy pregnancy. 3 groups will be formed: Group1 consists of women&#xD;
        performing moderate to vigorous physical activity (PA) before and in early pregnancy.&#xD;
        Group2 consists of women who are not physically active, and Group3 consists of women with a&#xD;
        risk of hypertensive disorders or metabolic diseases (not diabetes). PA before and in early&#xD;
        pregnancy will be assessed with a screening questionnaire. Women reporting a minimum of 150&#xD;
        mins of moderate to vigorous PA per week will be classified as active, women with less PA&#xD;
        will be classified as inactive. 20 women each group will be recruited not later than 14&#xD;
        weeks of gestation. Women will be recruited at the outpatient clinic at the Department of&#xD;
        Obstetrics and Gynecology, Medical University of Graz.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ongoing pregnancy no later than 14 weeks of gestation&#xD;
&#xD;
          -  giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not wanting to give birth at the University Hospital&#xD;
&#xD;
          -  gestational age &gt; 14 weeks of gestation&#xD;
&#xD;
          -  3 or more consecutive miscarriages&#xD;
&#xD;
          -  increased risk to or above 1:200 after combined test (Minimum parameters: maternal&#xD;
             age, fetal crown-rump length (CRL), nuchal translucency, nasal bone and maternal&#xD;
             biochemistry)&#xD;
&#xD;
          -  fetal anomalies associated with possible growth or genetic anomalies&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  diagnosed with Diabetes type 1 or 2 (T1D, T2D)&#xD;
&#xD;
          -  for groups 1 and 2: maternal metabolic risk factors (autoimmune conditions, increased&#xD;
             risk for thromboembolic events needing anticoagulative therapy)&#xD;
&#xD;
          -  for groups 1 and 2: pre-pregnancy hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bence Csapo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03277807
org study id: EK 24-245 ex 11/12
nct id: NCT03277807
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective observational study assesses whether women who regularly exercise during
      pregnancy show reduced low grade Inflammation, compared to women who are not regularly
      exercising. Furthermore, the effects of regular physical activity in pregnancy on fetal and
      neonatal outcomes will be investigated. 3 groups of pregnant women will be formed (group 1:
      regularly physically active women; group 2: physically inactive women and group 3: women with
      a history of preeclampsia or positive history of metabolic conditions increasing the risk of
      hypertensive disorders in pregnancy).
Pregnancy is a natural state of low grade inflammation in the mother and the feto-placental
      unit. The severity of this inflammation increases with higher pregravid Body Mass Index
      (BMI). This is reflected by an increase in pro-inflammatory cytokines in the maternal
      circulation and in the placenta. It has been proposed that the pro-inflammatory maternal and
      fetal environment plays a role in mediating pregnancy outcomes.

      In non-pregnant individuals regular physical activity is associated with a reduced
      inflammatory state. The overall objective of the study is to investigate the interaction of
      maternal physical activity and pregnancy induced low-grade inflammation in the mother and
      feto-placental unit, and to assess th resulting effects on prenatal and postnatal
      development.

      Specific research objective will be to study effects of maternal physical activity on:

        1. low grade Inflammation in the mother an feto-placental unit;

        2. maternal and fetal lipid profiles, including High Density Lipoprotein (HDL) proteome;

        3. fetal growth and infant body composition;

        4. transcriptomic and epigenetic profile in the placenta;

        5. biomarkers of nutritive status;

        6. psychological assessment: cardiac awareness; assessment of arterial stiffness;
           stress-coping questionaire
observational model: Cohort
time perspective: Prospective
measure: low grade inflammation (in maternal and cord blood)
time frame: 1 year
description: clinical inflammation markers: C-reactive protein, cytokines and chemokine (IL1b, IL1a, IL-2, IL-5, IL-6,IL-12, TNFa, MCP-1, MIP1-a) measured by ELISA and multiplexing arrays
measure: maternal and fetal (cord blood) lipid profiles
time frame: 1 year
description: triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol
measure: neonatal body composition (% body fat)
time frame: 1 year
description: measured by air displacement plethysmography (Peapod)
measure: maternal and newborn fat distribution
time frame: 1 year
description: subcutaneous adipose tissue thickness at 15 defined body sites, measured by a lipometer
measure: fetal growth
time frame: 1 year
description: measured by ultrasound scanner
measure: transcriptome of the placenta
time frame: 2 years
description: measured by full genome arrays
measure: epigenetic analysis of the placenta
time frame: 2 years
description: analysed by 450k methylation arrays
measure: biomarkers of nutritional status
time frame: 2 years
description: measurement of blood levels of fatty acids (DHA, EPA, 15:0, 17:0), vitamin A, B1, B2, B6, D2/D3, C, E, homocysteine
measure: psychological assessment
time frame: 1 year
description: assessment of arterial stiffness, stress coping questionnaire, cardiac awareness
arm group label: Active
description: pregnant women who are physically active (spend a minimum of 150min/week with moderate to vigorous physical activity)
arm group label: Inactive
description: pregnant women who are physically inactive (spend less than 150min/week with moderate to vigorous physical activity)
arm group label: risk for hypertensive disorders
description: pregnant women with a history of preeclampsia or positive history for metabolic conditions increasing the risk of hypertensive disorders in pregnancy
maternal venous blood (serum /plasma), cord blood (serum /plasma); placenta tissue (RNA
      later);
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bence Csapo, MD
role: Principal Investigator
affiliation: Medical University of Graz
responsible party type: Sponsor