<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/NCT02244385</url>
  </required_header>
  <id_info>
    <org_study_id>11/NW/0426</org_study_id>
    <nct_id>NCT02244385</nct_id>
  </id_info>
  <brief_title>Manchester Antenatal Vascular Service</brief_title>
  <acronym>MAViS</acronym>
  <official_title>Manchester Antenatal Vascular Service</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity)&#xD;
      will develop pre-eclampsia and or growth restriction. In addition, the frequency of&#xD;
      stillbirths in this group is dramatically increased over the general population. Pregnancy&#xD;
      complications in this very heterogeneous group are likely to be a combination of a failure of&#xD;
      the maternal vasculature to adapt to pregnancy and/or a failure of placental development. The&#xD;
      relative contribution of these two mechanisms is poorly understood and current preventative&#xD;
      strategies (aspirin) in this group only prevent a small number of adverse outcomes. This&#xD;
      important and complex group have been inadequately investigated to date mainly because of the&#xD;
      diversity of their underlying disease complicating prospective research studies.&#xD;
&#xD;
      The evolution of tools which allow more detailed assessments of both uteroplacental blood&#xD;
      flow and maternal vascular function will enable us to perform prospective studies in these&#xD;
      women and to develop targeted preventative measures. Recent biomarker studies have also&#xD;
      identified a number of biomarkers which have not yet been assessed in these high risk groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Blood Pressure</measure>
    <time_frame>At recruitment (&lt;14 weeks gestation) and at 16-18 weeks, 22-26 weeks &amp; 30-34 weeks gestation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vascular compliance</measure>
    <time_frame>At recruitment (&lt;14 weeks gestation) and at 16-18 weeks, 22-26 weeks &amp; 30-34 weeks gestation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uteroplacental assessment</measure>
    <time_frame>At recruitment (&lt;14 weeks gestation) and at 16-18 weeks, 22-26 weeks &amp; 30-34 weeks gestation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>urinary albumin</measure>
    <time_frame>At recruitment (&lt;14 weeks gestation) and at 16-18 weeks, 22-26 weeks &amp; 30-34 weeks gestation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary podocyte markers</measure>
    <time_frame>At recruitment (&lt;14 weeks gestation) and at 16-18 weeks, 22-26 weeks &amp; 30-34 weeks gestation</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">750</enrollment>
  <condition>Vascular Disease</condition>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <arm_group_label>Observation</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood sample Urine sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women will be approached about the study in a dedicated clinic run within the Maternal &amp;&#xD;
        Fetal Health Research Centre.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women with preexisting vascular disease:&#xD;
&#xD;
          1. chronic hypertension BP ≥140/90 at ≤14 weeks&#xD;
&#xD;
          2. chronic hypertension requiring antihypertensive treatment ≤ 14 weeks&#xD;
&#xD;
          3. pre gestational diabetes with evidence of vascular complications (hypertension,&#xD;
             nephropathy)&#xD;
&#xD;
          4. history of ischemic heart disease&#xD;
&#xD;
          5. previous early onset pre-eclampsia (delivery &lt; 32 weeks)&#xD;
&#xD;
          6. Obesity (BMI ≥ 40) with any history of hypertension or booking BP≥130/80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Women who do not meet the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenny Myers, PhD MRCOG BM BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maternal &amp; Fetal Health Research Centre, 5th Floor St Mary's Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vascular disease</keyword>
  <keyword>pregnancy</keyword>
  <keyword>chronic hypertension</keyword>
  <keyword>diabetes</keyword>
  <keyword>obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</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/NCT02244385
org study id: 11/NW/0426
nct id: NCT02244385
lead sponsor: 
collaborator: 
has dmc: No
25-30% of women with preexisting vascular disease (chronic hypertension/diabetes/obesity)
      will develop pre-eclampsia and or growth restriction. In addition, the frequency of
      stillbirths in this group is dramatically increased over the general population. Pregnancy
      complications in this very heterogeneous group are likely to be a combination of a failure of
      the maternal vasculature to adapt to pregnancy and/or a failure of placental development. The
      relative contribution of these two mechanisms is poorly understood and current preventative
      strategies (aspirin) in this group only prevent a small number of adverse outcomes. This
      important and complex group have been inadequately investigated to date mainly because of the
      diversity of their underlying disease complicating prospective research studies.

      The evolution of tools which allow more detailed assessments of both uteroplacental blood
      flow and maternal vascular function will enable us to perform prospective studies in these
      women and to develop targeted preventative measures. Recent biomarker studies have also
      identified a number of biomarkers which have not yet been assessed in these high risk groups.
observational model: Cohort
time perspective: Prospective
measure: Blood Pressure
time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
measure: Vascular compliance
time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
measure: Uteroplacental assessment
time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
measure: urinary albumin
time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
measure: Urinary podocyte markers
time frame: At recruitment (<14 weeks gestation) and at 16-18 weeks, 22-26 weeks & 30-34 weeks gestation
arm group label: Observation
description: No intervention
intervention type: Other
intervention name: no intervention
arm group label: Observation
Whole blood sample Urine sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jenny Myers, PhD MRCOG BM BS
role: Principal Investigator
affiliation: University of Manchester
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Vascular Diseases