<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/NCT01734460</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-12-RT-0510-12-TLV-CTIL</org_study_id>
    <nct_id>NCT01734460</nct_id>
  </id_info>
  <brief_title>Maternal Sleep Disordered Breathing and Fetal Growth</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <brief_summary>
    <textblock>
      Sleep disordered breathing (SDB) is a common condition affecting up to 9% of adults with&#xD;
      serious neurocognitive, metabolic and cardiovascular consequences that has a significant&#xD;
      impact on public health. Evidence indicates that the physiologic changes occurring during&#xD;
      pregnancy, particularly during the third trimester, increase the risk of those women to&#xD;
      develop SDB. As in the general population, SDB during pregnancy is more frequent among obese&#xD;
      women. In the light of the increasing prevalence of obesity among females of reproductive&#xD;
      age, SDB may thus have an increasingly significant impact on women's and children's health by&#xD;
      contributing to the adverse maternal and fetal outcomes associated with maternal obesity.&#xD;
&#xD;
      Only a limited amount of data is available on the consequences of maternal SDB during&#xD;
      pregnancy. Even less information is available on the effect of maternal SDB on fetal growth&#xD;
      and development. The current proposal is designed to specifically explore the effect of&#xD;
      maternal SDB on fetal growth.&#xD;
&#xD;
      It has been suggested that fetal growth as reflected in birth weight is a strong correlate&#xD;
      for conditions occurring in the intrauterine environment with potential long lasting&#xD;
      influence on a child's health.&#xD;
&#xD;
      Our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the&#xD;
      metabolic alterations associated with maternal SDB will affect fetal growth.&#xD;
&#xD;
      Using a variety of methods and a multidisciplinary approach, we will explore the following&#xD;
      objectives: 1) The effect of maternal SDB on fetal growth ; 2) To explore mechanisms that may&#xD;
      underlay the effect of maternal SDB on fetal growth 3) To explore the long term (first 3&#xD;
      years of life) effect of maternal SDB on a child's growth.&#xD;
&#xD;
      The results of this study will make an important contribution to the fields of women and&#xD;
      children's health. It will provide better insight into the mechanisms by which disrupted&#xD;
      maternal sleep affects fetal growth.&#xD;
&#xD;
      We expect that the findings from our study will enable the defining of a new treatable&#xD;
      clinical entity or syndrome: &quot;the infant of the gestational SDB mother&quot;, for which early&#xD;
      diagnosis and intervention might be of major importance to the newborn infant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <primary_completion_date type="Anticipated">December 2016</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>birth weight</measure>
    <time_frame>at birth</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>birth length</measure>
    <time_frame>at birth</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>birth head circumference</measure>
    <time_frame>at birth</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Sleep Disordered Breathing</condition>
  <arm_group>
    <arm_group_label>third trimester pregnant women</arm_group_label>
    <description>no intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        women health care centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  low risk third trimester pregnant women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy complications (preeclampsia, HTN, GDM),&#xD;
&#xD;
          -  any chronic medical condition.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Riva Tauman, MD</last_name>
    <email>tauman@tlvmc.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tel Aviv Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Riva Tauman, MD</last_name>
      <email>tauman@tlvmc.gov.il</email>
    </contact>
    <investigator>
      <last_name>Riva Tauman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Riva Tauman, MD</last_name>
      <email>tauman@tlvmc.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy, snoring, fetal growth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
  </condition_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/NCT01734460
org study id: TASMC-12-RT-0510-12-TLV-CTIL
nct id: NCT01734460
lead sponsor: 
Sleep disordered breathing (SDB) is a common condition affecting up to 9% of adults with
      serious neurocognitive, metabolic and cardiovascular consequences that has a significant
      impact on public health. Evidence indicates that the physiologic changes occurring during
      pregnancy, particularly during the third trimester, increase the risk of those women to
      develop SDB. As in the general population, SDB during pregnancy is more frequent among obese
      women. In the light of the increasing prevalence of obesity among females of reproductive
      age, SDB may thus have an increasingly significant impact on women's and children's health by
      contributing to the adverse maternal and fetal outcomes associated with maternal obesity.

      Only a limited amount of data is available on the consequences of maternal SDB during
      pregnancy. Even less information is available on the effect of maternal SDB on fetal growth
      and development. The current proposal is designed to specifically explore the effect of
      maternal SDB on fetal growth.

      It has been suggested that fetal growth as reflected in birth weight is a strong correlate
      for conditions occurring in the intrauterine environment with potential long lasting
      influence on a child's health.

      Our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the
      metabolic alterations associated with maternal SDB will affect fetal growth.

      Using a variety of methods and a multidisciplinary approach, we will explore the following
      objectives: 1) The effect of maternal SDB on fetal growth ; 2) To explore mechanisms that may
      underlay the effect of maternal SDB on fetal growth 3) To explore the long term (first 3
      years of life) effect of maternal SDB on a child's growth.

      The results of this study will make an important contribution to the fields of women and
      children's health. It will provide better insight into the mechanisms by which disrupted
      maternal sleep affects fetal growth.

      We expect that the findings from our study will enable the defining of a new treatable
      clinical entity or syndrome: "the infant of the gestational SDB mother", for which early
      diagnosis and intervention might be of major importance to the newborn infant.
observational model: Cohort
time perspective: Prospective
measure: birth weight
time frame: at birth
measure: birth length
time frame: at birth
measure: birth head circumference
time frame: at birth
arm group label: third trimester pregnant women
description: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Riva Tauman, MD
email: tauman@tlvmc.gov.il
facility: 
contact: 
investigator: 
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Sleep Apnea Syndromes