<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/NCT02968316</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT02968316</nct_id>
  </id_info>
  <brief_title>Bioelectric Impedance Analysis and Pregnancy Outcomes</brief_title>
  <official_title>Bioelectric Impedance Analysis and Pregnancy Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maternal Fetal Medicine Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maternal Fetal Medicine Associates</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational study correlating Body Impedance Analysis (BIA) with&#xD;
      pregnancy outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BIA is a new method of measuring total body water, fat, and lean mass. It is measured&#xD;
      noninvasively, and the investigators plan on using the InBody analyzer (www.InBody.com) in&#xD;
      this study. The analysis takes a few seconds and only requires the participant to stand on a&#xD;
      small platform and grasp a small device in each hand. The machine then uses low electrical&#xD;
      current to analyze the body composition and produce a read-out.&#xD;
&#xD;
      The investigators plan on doing this analysis longitudinally across gestation in multiple&#xD;
      trimesters to analyze the ability to predict maternal morbid conditions prior to the current&#xD;
      clinically-based criteria as a novel marker to aid in routine prenatal care, as compared to&#xD;
      the traditional weight measurement currently being done.&#xD;
&#xD;
      Both increased maternal prepregnancy weight (body mass index) and increased maternal&#xD;
      gestational weight gain have been associated with increased risks of multiple obstetrical&#xD;
      complications (both maternal and fetal). The investigators seek to compare the current&#xD;
      standard with BIA in its ability to predict maternal/fetal adverse outcomes such as&#xD;
      gestational diabetes, preeclampsia, and cesarean delivery.&#xD;
&#xD;
      PRIOR RESEARCH&#xD;
&#xD;
      There are a few studies in pregnant patients correlating BIA and pregnancy outcomes:&#xD;
&#xD;
        1. Sween et al performed BIA on 370 women and found that body fat composition correlated&#xD;
           with the development of preeclampsia.&#xD;
&#xD;
        2. Gomes de Silva et al performed BIA in 65 women with preeclampsia and 51 controls and&#xD;
           found that BIA results differed between the two groups.&#xD;
&#xD;
        3. Marshall et al performed BIA on 41 pregnant women in the third trimester as part of a&#xD;
           multimodal analysis of body composition&#xD;
&#xD;
        4. Xu et al correlated BIA with the onset of gestational diabetes&#xD;
&#xD;
      PROTOCOL&#xD;
&#xD;
        -  Patients in this MFM practice will be approached at the time of their initial pregnancy&#xD;
           visit and asked to participate.&#xD;
&#xD;
        -  If they agree and sign informed consent, the following will occur:&#xD;
&#xD;
             -  The participant's name will be placed on a list of participants&#xD;
&#xD;
             -  The participant will have an InBody analysis performed by one of the office nurses&#xD;
                or medical assistants. The results will not be shared with the participant nor the&#xD;
                treating physicians. Rather, the results will be filed until after the participant&#xD;
                delivers.&#xD;
&#xD;
             -  Participants will have the InBody analysis performed in each trimester at the time&#xD;
                of scheduled office visits as well as at the post-partum visit, which is routinely&#xD;
                scheduled at approximately 6 weeks after delivery. Those results will also not be&#xD;
                shared with the participants or physicians.&#xD;
&#xD;
             -  After the postpartum visit, the data from the InBody analysis will be entered into&#xD;
                a de-identified database, along with the participant's baseline characteristics,&#xD;
                pregnancy events, and delivery outcomes, all of which are already in the&#xD;
                participant's office chart. No personal identifiers will be required for the&#xD;
                database. The data will be used to correlate InBody results with pregnancy&#xD;
                outcomes.&#xD;
&#xD;
             -  The only identifier will be the actual list of participants, which is required to&#xD;
                plan for who needs InBody analysis during their prenatal visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Preeclampsia</measure>
    <time_frame>from date of enrollment up to 6 weeks after delivery (within 1 year)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gestational diabetes</measure>
    <time_frame>from date of enrollment up to 6 weeks after delivery (within 1 year)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>cesarean delivery</measure>
    <time_frame>from date of enrollment up to delivery (within 1 year)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>neonatal birth weight</measure>
    <time_frame>from date of enrollment up to delivery (within 1 year)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gestational age at delivery</measure>
    <time_frame>from date of enrollment up to delivery (within 1 year)</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>all consecutive pregnant women presenting for prenatal care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BIA measurement</intervention_name>
    <description>observation only</description>
    <arm_group_label>Pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nathan Fox, MD</last_name>
    <phone>2127227409</phone>
    <email>nfox@mfmnyc.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>andrei rebarber, MD</last_name>
    <phone>2127227409</phone>
    <email>arebarber@mfmnyc.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maternal Fetal Medicine Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Nathan Fox, MD</last_name>
      <phone>212-722-7409</phone>
      <email>nfox@mfmnyc.com</email>
    </contact>
    <contact_backup>
      <last_name>Andrei Rebarber, MD</last_name>
      <phone>2127227409</phone>
      <email>arebarber@mfmnyc.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maternal Fetal Medicine Associates</investigator_affiliation>
    <investigator_full_name>Nathan Fox</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02968316
org study id: 1
nct id: NCT02968316
lead sponsor: 
has dmc: No
This is a prospective observational study correlating Body Impedance Analysis (BIA) with
      pregnancy outcomes.
BIA is a new method of measuring total body water, fat, and lean mass. It is measured
      noninvasively, and the investigators plan on using the InBody analyzer (www.InBody.com) in
      this study. The analysis takes a few seconds and only requires the participant to stand on a
      small platform and grasp a small device in each hand. The machine then uses low electrical
      current to analyze the body composition and produce a read-out.

      The investigators plan on doing this analysis longitudinally across gestation in multiple
      trimesters to analyze the ability to predict maternal morbid conditions prior to the current
      clinically-based criteria as a novel marker to aid in routine prenatal care, as compared to
      the traditional weight measurement currently being done.

      Both increased maternal prepregnancy weight (body mass index) and increased maternal
      gestational weight gain have been associated with increased risks of multiple obstetrical
      complications (both maternal and fetal). The investigators seek to compare the current
      standard with BIA in its ability to predict maternal/fetal adverse outcomes such as
      gestational diabetes, preeclampsia, and cesarean delivery.

      PRIOR RESEARCH

      There are a few studies in pregnant patients correlating BIA and pregnancy outcomes:

        1. Sween et al performed BIA on 370 women and found that body fat composition correlated
           with the development of preeclampsia.

        2. Gomes de Silva et al performed BIA in 65 women with preeclampsia and 51 controls and
           found that BIA results differed between the two groups.

        3. Marshall et al performed BIA on 41 pregnant women in the third trimester as part of a
           multimodal analysis of body composition

        4. Xu et al correlated BIA with the onset of gestational diabetes

      PROTOCOL

        -  Patients in this MFM practice will be approached at the time of their initial pregnancy
           visit and asked to participate.

        -  If they agree and sign informed consent, the following will occur:

             -  The participant's name will be placed on a list of participants

             -  The participant will have an InBody analysis performed by one of the office nurses
                or medical assistants. The results will not be shared with the participant nor the
                treating physicians. Rather, the results will be filed until after the participant
                delivers.

             -  Participants will have the InBody analysis performed in each trimester at the time
                of scheduled office visits as well as at the post-partum visit, which is routinely
                scheduled at approximately 6 weeks after delivery. Those results will also not be
                shared with the participants or physicians.

             -  After the postpartum visit, the data from the InBody analysis will be entered into
                a de-identified database, along with the participant's baseline characteristics,
                pregnancy events, and delivery outcomes, all of which are already in the
                participant's office chart. No personal identifiers will be required for the
                database. The data will be used to correlate InBody results with pregnancy
                outcomes.

             -  The only identifier will be the actual list of participants, which is required to
                plan for who needs InBody analysis during their prenatal visit.
observational model: Cohort
time perspective: Prospective
measure: Preeclampsia
time frame: from date of enrollment up to 6 weeks after delivery (within 1 year)
measure: gestational diabetes
time frame: from date of enrollment up to 6 weeks after delivery (within 1 year)
measure: cesarean delivery
time frame: from date of enrollment up to delivery (within 1 year)
measure: neonatal birth weight
time frame: from date of enrollment up to delivery (within 1 year)
measure: gestational age at delivery
time frame: from date of enrollment up to delivery (within 1 year)
arm group label: Pregnant women
description: all consecutive pregnant women presenting for prenatal care
intervention type: Other
intervention name: BIA measurement
description: observation only
arm group label: Pregnant women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nathan Fox, MD
phone: 2127227409
email: nfox@mfmnyc.com
last name: andrei rebarber, MD
phone: 2127227409
email: arebarber@mfmnyc.com
facility: 
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Maternal Fetal Medicine Associates
investigator full name: Nathan Fox
investigator title: Physician
mesh term: Pregnancy Complications
sharing ipd: No