<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/NCT03831126</url>
  </required_header>
  <id_info>
    <org_study_id>PerFet_maternal_stress_fMEG</org_study_id>
    <nct_id>NCT03831126</nct_id>
  </id_info>
  <brief_title>Stress and Fetal Brain Development</brief_title>
  <official_title>The Impact of Stress on Fetal Brain Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      The current proposal aims to investigate the impact of acute stress on the fetal autonomic&#xD;
      nervous system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the last decades there is growing evidence that increased maternal stress levels lead to&#xD;
      an adverse effect on the physiological, metabolic and neuronal development of the fetus&#xD;
      during gestation with possible long-lasting effects. Several studies showed that maternal&#xD;
      stress also affects fetal endocrine processes during pregnancy and increases the risk for&#xD;
      childhood and adult obesity. Thus, the aim of the study is to investigate the effect of acute&#xD;
      stress related to the action of the artificial glucocorticoid betamethasone on fetal heart&#xD;
      and brain activity. The fetal activity will be measured with biomagnetic sensors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>fetal and maternal heart rate</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurement by fMEG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fetal and neonatal brain activity in response to auditory and visual stimuli</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurement by fMEG</description>
  </secondary_outcome>
  <other_outcome>
    <measure>blood sugar levels</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurement by fMEG</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>betamethasone treatment</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betamethason Sodium Phosphate</intervention_name>
    <description>First measurement: 12-36 hours after betamethasone treatment Second measurement: within five days after betamethasone treatment and two weeks Third measurement (neonatal measurement): 1-8 weeks after birh</description>
    <arm_group_label>betamethasone treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  German speakers (fluently)&#xD;
&#xD;
          -  Gestational age between 28 and 34 weeks&#xD;
&#xD;
          -  Treatment with Betamethasone for improvement of fetal lung function -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking (regularly)&#xD;
&#xD;
          -  Alcohol and drug consumption during pregnancy&#xD;
&#xD;
          -  Congenital fetal disorders&#xD;
&#xD;
          -  Women with bed rest&#xD;
&#xD;
          -  acute depression or other psychiatric disorder (self report)&#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_contact>
    <last_name>Jan Pauluschke-Fröhlich, MD</last_name>
    <phone>07071 2983111</phone>
    <email>jan.pauluschke-froehlich@med.uni-tuebingen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Tuebingen, Department of Women's Health</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miriam Linneweh, Dr</last_name>
      <phone>+4970712982211</phone>
      <email>miriam.linneweh@med.uni-tuebingen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Betamethasone benzoate</mesh_term>
    <mesh_term>Betamethasone sodium phosphate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03831126
org study id: PerFet_maternal_stress_fMEG
nct id: NCT03831126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current proposal aims to investigate the impact of acute stress on the fetal autonomic
      nervous system.
Over the last decades there is growing evidence that increased maternal stress levels lead to
      an adverse effect on the physiological, metabolic and neuronal development of the fetus
      during gestation with possible long-lasting effects. Several studies showed that maternal
      stress also affects fetal endocrine processes during pregnancy and increases the risk for
      childhood and adult obesity. Thus, the aim of the study is to investigate the effect of acute
      stress related to the action of the artificial glucocorticoid betamethasone on fetal heart
      and brain activity. The fetal activity will be measured with biomagnetic sensors.
observational model: Case-Only
time perspective: Prospective
measure: fetal and maternal heart rate
time frame: 8 weeks
description: Measurement by fMEG
measure: fetal and neonatal brain activity in response to auditory and visual stimuli
time frame: 8 weeks
description: Measurement by fMEG
measure: blood sugar levels
time frame: 8 weeks
description: Measurement by fMEG
arm group label: betamethasone treatment
intervention type: Drug
intervention name: Betamethason Sodium Phosphate
description: First measurement: 12-36 hours after betamethasone treatment Second measurement: within five days after betamethasone treatment and two weeks Third measurement (neonatal measurement): 1-8 weeks after birh
arm group label: betamethasone treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Pauluschke-Fröhlich, MD
phone: 07071 2983111
email: jan.pauluschke-froehlich@med.uni-tuebingen.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Betamethasone-17,21-dipropionate
mesh term: Betamethasone benzoate
mesh term: Betamethasone sodium phosphate