<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/NCT01669525</url>
  </required_header>
  <id_info>
    <org_study_id>811129</org_study_id>
    <nct_id>NCT01669525</nct_id>
  </id_info>
  <brief_title>Placental Growth and Adverse Pregnancy Outcomes</brief_title>
  <official_title>Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study to determine if measurement of maternal serum biomarkers and&#xD;
      evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental&#xD;
      dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes,&#xD;
      including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed&#xD;
      for measurement of placental volumes during pregnancy. It may be that quantitative assessment&#xD;
      of early placental growth can help identify pregnancies at risk for adverse outcome.&#xD;
      Furthermore, various novel serum analytes have been proposed as predictors of adverse&#xD;
      outcome. The investigators seek to prospectively measure placental volume and diameter at&#xD;
      11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In&#xD;
      addition, the investigators seek to investigate the relationship between placental growth and&#xD;
      serum levels of various biomarkers to see if improved detection of adverse outcome can be&#xD;
      achieved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Small for gestational birth weight (SGA-dichotomous)</measure>
    <time_frame>from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)</time_frame>
    <description>Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.</measure>
    <time_frame>post partum</time_frame>
    <description>Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1043</enrollment>
  <condition>Hypertension Induced by Pregnancy</condition>
  <condition>Pre-Eclampsia</condition>
  <condition>IUGR</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal serum will be collected. Placental biopsies may be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Singleton pregnancies presenting for Sequential Screen prior to 14 weeks gestation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All singleton gestations presenting for Sequential Screen testing at HUP&#xD;
&#xD;
          -  patients competent to provide verbal informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple gestations&#xD;
&#xD;
          -  patients not competent to provide informed consent&#xD;
&#xD;
          -  patients found to be too late for the Sequential Screen&#xD;
&#xD;
          -  pregnancy losses 20 weeks gestation&#xD;
&#xD;
          -  major fetal anomalies&#xD;
&#xD;
          -  patient delivering outside of the UPHS&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadav Schwartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>July 17, 2017</last_update_submitted>
  <last_update_submitted_qc>July 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Hypertension, Pregnancy-Induced</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/NCT01669525
org study id: 811129
nct id: NCT01669525
lead sponsor: 
has dmc: No
The purpose of this study to determine if measurement of maternal serum biomarkers and
      evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy
      outcomes.
The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental
      dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes,
      including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed
      for measurement of placental volumes during pregnancy. It may be that quantitative assessment
      of early placental growth can help identify pregnancies at risk for adverse outcome.
      Furthermore, various novel serum analytes have been proposed as predictors of adverse
      outcome. The investigators seek to prospectively measure placental volume and diameter at
      11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In
      addition, the investigators seek to investigate the relationship between placental growth and
      serum levels of various biomarkers to see if improved detection of adverse outcome can be
      achieved.
observational model: Cohort
time perspective: Prospective
measure: Small for gestational birth weight (SGA-dichotomous)
time frame: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)
description: Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.
measure: Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.
time frame: post partum
description: Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.
arm group label: No treatment
description: Singleton pregnancies presenting to the Genetic Counselor for Sequential Screening prior to 14 weeks gestation.
Maternal serum will be collected. Placental biopsies may be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nadav Schwartz, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Hypertension, Pregnancy-Induced