xml: <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/NCT06042348</url>
    </required_header>
    <id_info>
      <org_study_id>W23.020</org_study_id>
      <nct_id>NCT06042348</nct_id>
    </id_info>
    <brief_title>Placenta Perfusion and Sufficiency Study</brief_title>
    <acronym>P2SS</acronym>
    <official_title>Placenta Perfusion and Sufficiency Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maxima Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maxima Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Ultrasonography will be used to determine the total blood flow to and from the uterus. This&#xD;
        is done by measuring the blood vessels coming from and going to the uterus. This wil&#xD;
        hopefully prove viable and open the possibility to further research in the clinical relevance&#xD;
        of these measurements.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This prospective pilot study takes place between 14- and 16-weeks' gestation (GA14 to 16&#xD;
        weeks). This is a feasibility study, as the perfusion measurements have not yet been&#xD;
        performed this early in pregnancy. First the feasibility is assessed, before conducting a&#xD;
        full-scale research project. The study will take place in a tertiary care obstetric centre,&#xD;
        Máxima Medical Center, in Veldhoven The Netherlands. Measurements will be done at the out&#xD;
        patient clinic of obstetrics. Duration of the study is 2 months. This gives ample time for&#xD;
        recruitment of the subjects.&#xD;
  &#xD;
        Recruitment will take place at the outpatient clinic of Máxima Medisch Centrum in Veldhoven.&#xD;
        Women with singleton pregnancies coming for their 11-12 weeks' gestational ultrasound, where&#xD;
        the pregnancy is dated, will be given a patient information folder in either Dutch or English&#xD;
        and asked if the researcher can contact them. Participation is completely on voluntary basis.&#xD;
        Patients will be called in the next days by the researcher to answer additional questions and&#xD;
        to ask if patients are willing to participate. Contact information of the researchers will be&#xD;
        available on the folder in case of questions.&#xD;
  &#xD;
        Upon inclusion, the patients will be scheduled for a visit to perform all relevant&#xD;
        measurements, henceforth referred to as 'measurement day' (MD) which is to take place between&#xD;
        14- and 16-weeks' gestation. The patient, henceforth to be referred to as participant, will&#xD;
        be asked to rest for 5 minutes in a supine position. After 5 minutes of rest the blood&#xD;
        pressure of the right arm will be measured, three times using the auto-sphygmomanometer. The&#xD;
        three measurements will then be used to calculate the average systolic and diastolic blood&#xD;
        pressures. After measurement of blood pressure, the ultrasound scan will be performed. The&#xD;
        uterine and placental vessels will be measured according to the standard operating procedure&#xD;
        attached to this document. All vessels will be measured 3 times during the ultrasound scan.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Uterine blood vessel flow</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>The feasibility of measuring placenta perfusion between 14-16 weeks of gestation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>uterine vessel differences</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>To assess whether there are differences in measurements between the two umbilical arteries</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relation between uterine vessels</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>To determine whether a relation between the uterine artery and vein flow exists</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Placenta Diseases, Diagnosis</condition>
    <condition>Pregnancy Related</condition>
    <condition>Female</condition>
    <condition>Human</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Trans abdominal ultrasound</intervention_name>
      <description>Ultra sound of the uterus and uterine blood vessels</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The base population are women with singleton pregnancies between 14- and 16 weeks'&#xD;
          gestation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Between 14-16 weeks gestation on measurement day&#xD;
  &#xD;
            -  Placenta anterior&#xD;
  &#xD;
            -  BMI &lt; 30kg/m2&#xD;
  &#xD;
            -  Ability to give consent&#xD;
  &#xD;
            -  Adequate mastery of the Dutch or English languages&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-intact pregnancy at 13 week's gestational echo.&#xD;
  &#xD;
            -  Vanishing twin&#xD;
  &#xD;
            -  Multiple gestations&#xD;
  &#xD;
            -  Congenital or anatomical anomalies at 13 weeks' gestational echo.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Loes Monen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maxima Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Maxima Medical Center</name>
        <address>
          <city>Veldhoven</city>
          <state>Braband</state>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sabnani</last_name>
        <phone>+31634385519</phone>
        <email>sahil_94@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Monen</last_name>
        <phone>(040) 888 8385</phone>
        <phone_ext>7338</phone_ext>
        <email>Loes.Monen@mmc.nl</email>
      </contact_backup>
      <investigator>
        <last_name>Loes Monen</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <reference>
      <citation>Gude NM, Roberts CT, Kalionis B, King RG. Growth and function of the normal human placenta. Thromb Res. 2004;114(5-6):397-407. doi: 10.1016/j.thromres.2004.06.038.</citation>
      <PMID>15507270</PMID>
    </reference>
    <reference>
      <citation>Fadl S, Moshiri M, Fligner CL, Katz DS, Dighe M. Placental Imaging: Normal Appearance with Review of Pathologic Findings. Radiographics. 2017 May-Jun;37(3):979-998. doi: 10.1148/rg.2017160155.</citation>
      <PMID>28493802</PMID>
    </reference>
    <reference>
      <citation>Brosens I, Pijnenborg R, Vercruysse L, Romero R. The &quot;Great Obstetrical Syndromes&quot; are associated with disorders of deep placentation. Am J Obstet Gynecol. 2011 Mar;204(3):193-201. doi: 10.1016/j.ajog.2010.08.009. Epub 2010 Nov 20.</citation>
      <PMID>21094932</PMID>
    </reference>
    <reference>
      <citation>Schiffer V, van Haren A, De Cubber L, Bons J, Coumans A, van Kuijk SM, Spaanderman M, Al-Nasiry S. Ultrasound evaluation of the placenta in healthy and placental syndrome pregnancies: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2021 Jul;262:45-56. doi: 10.1016/j.ejogrb.2021.04.042. Epub 2021 May 4.</citation>
      <PMID>33984727</PMID>
    </reference>
    <reference>
      <citation>Mol BWJ, Roberts CT, Thangaratinam S, Magee LA, de Groot CJM, Hofmeyr GJ. Pre-eclampsia. Lancet. 2016 Mar 5;387(10022):999-1011. doi: 10.1016/S0140-6736(15)00070-7. Epub 2015 Sep 2.</citation>
      <PMID>26342729</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Maxima Medical Center</investigator_affiliation>
      <investigator_full_name>Sahil Joseph Gregory Manoj Sabnani</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Placenta</keyword>
    <keyword>Human</keyword>
    <keyword>Pregnancy</keyword>
    <keyword>Early pregnancy</keyword>
    <keyword>Hypertension disorders</keyword>
    <keyword>Uterus</keyword>
    <keyword>Uterine artery</keyword>
    <keyword>Uterine vein</keyword>
    <keyword>Placental circulation</keyword>
    <keyword>Placenta physiology</keyword>
    <keyword>Netherlands</keyword>
    <keyword>Placenta development</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Placenta Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042348
  org study id: W23.020
  nct id: NCT06042348
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Ultrasonography will be used to determine the total blood flow to and from the uterus. This
        is done by measuring the blood vessels coming from and going to the uterus. This wil
        hopefully prove viable and open the possibility to further research in the clinical relevance
        of these measurements.
  This prospective pilot study takes place between 14- and 16-weeks' gestation (GA14 to 16
        weeks). This is a feasibility study, as the perfusion measurements have not yet been
        performed this early in pregnancy. First the feasibility is assessed, before conducting a
        full-scale research project. The study will take place in a tertiary care obstetric centre,
        Máxima Medical Center, in Veldhoven The Netherlands. Measurements will be done at the out
        patient clinic of obstetrics. Duration of the study is 2 months. This gives ample time for
        recruitment of the subjects.
  
        Recruitment will take place at the outpatient clinic of Máxima Medisch Centrum in Veldhoven.
        Women with singleton pregnancies coming for their 11-12 weeks' gestational ultrasound, where
        the pregnancy is dated, will be given a patient information folder in either Dutch or English
        and asked if the researcher can contact them. Participation is completely on voluntary basis.
        Patients will be called in the next days by the researcher to answer additional questions and
        to ask if patients are willing to participate. Contact information of the researchers will be
        available on the folder in case of questions.
  
        Upon inclusion, the patients will be scheduled for a visit to perform all relevant
        measurements, henceforth referred to as 'measurement day' (MD) which is to take place between
        14- and 16-weeks' gestation. The patient, henceforth to be referred to as participant, will
        be asked to rest for 5 minutes in a supine position. After 5 minutes of rest the blood
        pressure of the right arm will be measured, three times using the auto-sphygmomanometer. The
        three measurements will then be used to calculate the average systolic and diastolic blood
        pressures. After measurement of blood pressure, the ultrasound scan will be performed. The
        uterine and placental vessels will be measured according to the standard operating procedure
        attached to this document. All vessels will be measured 3 times during the ultrasound scan.
  observational model: Cohort
  time perspective: Prospective
  measure: Uterine blood vessel flow
  time frame: Through study completion, an average of 1 year
  description: The feasibility of measuring placenta perfusion between 14-16 weeks of gestation
  measure: uterine vessel differences
  time frame: Through study completion, an average of 1 year
  description: To assess whether there are differences in measurements between the two umbilical arteries
  measure: Relation between uterine vessels
  time frame: Through study completion, an average of 1 year
  description: To determine whether a relation between the uterine artery and vein flow exists
  arm group label: Group 1
  intervention type: Diagnostic Test
  intervention name: Trans abdominal ultrasound
  description: Ultra sound of the uterus and uterine blood vessels
  arm group label: Group 1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Loes Monen
  role: Principal Investigator
  affiliation: Maxima Medical Center
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Netherlands
  citation: Gude NM, Roberts CT, Kalionis B, King RG. Growth and function of the normal human placenta. Thromb Res. 2004;114(5-6):397-407. doi: 10.1016/j.thromres.2004.06.038.
  PMID: 15507270
  citation: Fadl S, Moshiri M, Fligner CL, Katz DS, Dighe M. Placental Imaging: Normal Appearance with Review of Pathologic Findings. Radiographics. 2017 May-Jun;37(3):979-998. doi: 10.1148/rg.2017160155.
  PMID: 28493802
  citation: Brosens I, Pijnenborg R, Vercruysse L, Romero R. The "Great Obstetrical Syndromes" are associated with disorders of deep placentation. Am J Obstet Gynecol. 2011 Mar;204(3):193-201. doi: 10.1016/j.ajog.2010.08.009. Epub 2010 Nov 20.
  PMID: 21094932
  citation: Schiffer V, van Haren A, De Cubber L, Bons J, Coumans A, van Kuijk SM, Spaanderman M, Al-Nasiry S. Ultrasound evaluation of the placenta in healthy and placental syndrome pregnancies: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2021 Jul;262:45-56. doi: 10.1016/j.ejogrb.2021.04.042. Epub 2021 May 4.
  PMID: 33984727
  citation: Mol BWJ, Roberts CT, Thangaratinam S, Magee LA, de Groot CJM, Hofmeyr GJ. Pre-eclampsia. Lancet. 2016 Mar 5;387(10022):999-1011. doi: 10.1016/S0140-6736(15)00070-7. Epub 2015 Sep 2.
  PMID: 26342729
  responsible party type: Principal Investigator
  investigator affiliation: Maxima Medical Center
  investigator full name: Sahil Joseph Gregory Manoj Sabnani
  investigator title: Principal Investigator
  mesh term: Placenta Diseases
  sharing ipd: Undecided