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/NCT06004674</url>
    </required_header>
    <id_info>
      <org_study_id>EH22-128</org_study_id>
      <nct_id>NCT06004674</nct_id>
    </id_info>
    <brief_title>Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project</brief_title>
    <official_title>Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project (UPPPP Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NorthShore University HealthSystem</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NorthShore University HealthSystem</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized clinical trial is to evaluate if we can use placental pathology&#xD;
        in a prior pregnancy which had an adverse outcome, such as early delivery, stillbirth, a baby&#xD;
        born smaller than expected, or severe forms of high blood pressure during pregnancy, to guide&#xD;
        treatment in the subsequent pregnancy and reduce risk of recurrent adverse pregnancy events.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Whether enoxaparin prevents recurrent adverse pregnancy outcomes among patients with a&#xD;
             prior adverse pregnancy outcome that occurred in the setting of maternal vascular&#xD;
             malperfusion (MVM).&#xD;
  &#xD;
          -  If enoxaparin reduces the occurrence or severity of MVM among patients with a prior&#xD;
             adverse pregnancy outcome that occurred in the setting of MVM.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this clinical trial, participants will undergo consent, blood samples will be collected,&#xD;
        and participants will be randomized in a 1:1 ratio to the enoxaparin or control groups at&#xD;
        their first study visit.&#xD;
  &#xD;
          -  Participants will return for a study visit within 1 week following randomization.&#xD;
  &#xD;
          -  If assigned to the enoxaparin, the participant will be asked to take a dose of the&#xD;
             enoxaparin once a day (40 mg daily) daily from 12 0/7 weeks and/or the start of&#xD;
             enrollment (whichever is later) and continue until 36 weeks gestational age, after which&#xD;
             enoxaparin will be discontinued.&#xD;
  &#xD;
          -  Participants in the control group will have care as usual, with no additional&#xD;
             medications.&#xD;
  &#xD;
          -  During this study, a study team member will collect a blood sample from all participants&#xD;
             at 20-24 weeks, 32-34 weeks, and at delivery.&#xD;
  &#xD;
          -  Participants in the enoxaparin group will have their blood work checked a week after&#xD;
             starting medication to ensure that they have no unanticipated side effects.&#xD;
  &#xD;
        Researchers will compare the enoxaparin group to the control group to see if enoxaparin&#xD;
        prevents or reduces the occurrence or severity of maternal vascular malperfusion (MVM) among&#xD;
        patients with a prior adverse pregnancy outcome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Placental pathologist will be masked to the outcome when assessing for maternal vascular malperfusion.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Composite Adverse Pregnancy outcome</measure>
      <time_frame>Enrollment through 6 weeks postpartum</time_frame>
      <description>Preeclampsia with severe features, small for gestational age infant, preterm delivery &lt;37 weeks, neonatal death, and maternal death</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maternal vascular malperfusion (MVM)</measure>
      <time_frame>Placenta collected at time of delivery</time_frame>
      <description>Presence/ absence of MVM on placental pathology</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preeclampsia with severe features</measure>
      <time_frame>Enrollment through 6 weeks postpartum</time_frame>
      <description>Defined by clinician</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Small for gestational age infant</measure>
      <time_frame>At time of delivery</time_frame>
      <description>By Fenton criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preterm delivery &lt; 37 weeks</measure>
      <time_frame>Assessed at time of delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal Death</measure>
      <time_frame>Assessed from time of delivery to 6 weeks postpartum</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal Death</measure>
      <time_frame>Assessed from enrollment to 6 weeks postpartum</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Adverse Pregnancy Outcome</condition>
    <arm_group>
      <arm_group_label>Enoxaparin Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the enoxaparin group will be asked to take a dose of the enoxaparin once a day (40 mg daily) daily from 12 0/7 weeks and/or start of enrollment (whichever is later), and continue until 36 weeks gestational age, after which enoxaparin will be discontinued.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this group will have standard care as usual, with no additional medications.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lovenox 40mg</intervention_name>
      <description>Enoxaparin is a blood thinner. It is approved for use in the prevention of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness; inpatient treatment of acute DVT with or without pulmonary embolism; outpatient treatment of acute DVT without pulmonary embolism; Prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction; treatment of acute ST-segment elevation myocardial infarction(STEMI) managed medically or with subsequent percutaneous coronary intervention. The use of Lovenox has been shown to be safe, and it has also been used widely off-label in pregnancy.</description>
      <arm_group_label>Enoxaparin Group</arm_group_label>
      <other_name>Enoxaparin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Eligibility Criteria:&#xD;
  &#xD;
          Inclusion (must meet all three criteria):&#xD;
  &#xD;
            1. Subjects with a prior adverse outcome in a prior pregnancy. Adverse outcome is defined&#xD;
               as prior singleton preterm birth ( &lt; 37 weeks), SGA infant (defined as birthweight &lt;&#xD;
               10th percentile), preeclampsia with severe features, or stillbirth (fetal demise after&#xD;
               20 weeks gestation), as certified by an obstetrician&#xD;
  &#xD;
            2. Patients with maternal vascular malperfusion on pathology from pregnancy with prior&#xD;
               adverse pregnancy outcome, as certified by a perinatal placental pathologist&#xD;
  &#xD;
            3. Current singleton pregnancy at &lt;16 6/7 weeks gestational age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Anticoagulation planned for current pregnancy (including warfarin, enoxaparin,&#xD;
               heparin)&#xD;
  &#xD;
            2. Known major fetal anomaly&#xD;
  &#xD;
            3. Contraindication to enoxaparin: Specifically active major bleeding, known&#xD;
               thrombocytopenia (platelets &lt;100), hypersensitivity to enoxaparin sodium,&#xD;
               hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol&#xD;
  &#xD;
            4. Chronic kidney disease with eGFR&lt; 60&#xD;
  &#xD;
            5. Known chronic liver disease with baseline AST/ALT &gt; 3 x upper limit of normal&#xD;
  &#xD;
            6. Subjects with mechanical prosthetic heart valves&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>This study will specifically recruit patients who are pregnant, and we anticipate that they will primarily be of female sex.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sunitha Suresh</last_name>
      <role>Principal Investigator</role>
      <affiliation>NorthShore University HealthSystem</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sunitha Suresh</last_name>
      <phone>(847) 570-2860</phone>
      <email>SSuresh@northshore.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Olivert Mbah</last_name>
      <phone>(847) 570 - 2243</phone>
      <email>OMbah@northshore.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>NorthShore University HealthSystem</investigator_affiliation>
      <investigator_full_name>Sunitha Suresh</investigator_full_name>
      <investigator_title>Physician, FPA</investigator_title>
    </responsible_party>
    <keyword>miscarriage</keyword>
    <keyword>preeclampsia</keyword>
    <keyword>preterm delivery</keyword>
    <keyword>stillbirth</keyword>
    <keyword>Low birth weight</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Enoxaparin</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06004674
  org study id: EH22-128
  nct id: NCT06004674
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this randomized clinical trial is to evaluate if we can use placental pathology
        in a prior pregnancy which had an adverse outcome, such as early delivery, stillbirth, a baby
        born smaller than expected, or severe forms of high blood pressure during pregnancy, to guide
        treatment in the subsequent pregnancy and reduce risk of recurrent adverse pregnancy events.
  
        The main questions it aims to answer are:
  
          -  Whether enoxaparin prevents recurrent adverse pregnancy outcomes among patients with a
             prior adverse pregnancy outcome that occurred in the setting of maternal vascular
             malperfusion (MVM).
  
          -  If enoxaparin reduces the occurrence or severity of MVM among patients with a prior
             adverse pregnancy outcome that occurred in the setting of MVM.
  In this clinical trial, participants will undergo consent, blood samples will be collected,
        and participants will be randomized in a 1:1 ratio to the enoxaparin or control groups at
        their first study visit.
  
          -  Participants will return for a study visit within 1 week following randomization.
  
          -  If assigned to the enoxaparin, the participant will be asked to take a dose of the
             enoxaparin once a day (40 mg daily) daily from 12 0/7 weeks and/or the start of
             enrollment (whichever is later) and continue until 36 weeks gestational age, after which
             enoxaparin will be discontinued.
  
          -  Participants in the control group will have care as usual, with no additional
             medications.
  
          -  During this study, a study team member will collect a blood sample from all participants
             at 20-24 weeks, 32-34 weeks, and at delivery.
  
          -  Participants in the enoxaparin group will have their blood work checked a week after
             starting medication to ensure that they have no unanticipated side effects.
  
        Researchers will compare the enoxaparin group to the control group to see if enoxaparin
        prevents or reduces the occurrence or severity of maternal vascular malperfusion (MVM) among
        patients with a prior adverse pregnancy outcome.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Placental pathologist will be masked to the outcome when assessing for maternal vascular malperfusion.
  measure: Composite Adverse Pregnancy outcome
  time frame: Enrollment through 6 weeks postpartum
  description: Preeclampsia with severe features, small for gestational age infant, preterm delivery <37 weeks, neonatal death, and maternal death
  measure: Maternal vascular malperfusion (MVM)
  time frame: Placenta collected at time of delivery
  description: Presence/ absence of MVM on placental pathology
  measure: Preeclampsia with severe features
  time frame: Enrollment through 6 weeks postpartum
  description: Defined by clinician
  measure: Small for gestational age infant
  time frame: At time of delivery
  description: By Fenton criteria
  measure: Preterm delivery < 37 weeks
  time frame: Assessed at time of delivery
  measure: Neonatal Death
  time frame: Assessed from time of delivery to 6 weeks postpartum
  measure: Maternal Death
  time frame: Assessed from enrollment to 6 weeks postpartum
  arm group label: Enoxaparin Group
  arm group type: Experimental
  description: Participants in the enoxaparin group will be asked to take a dose of the enoxaparin once a day (40 mg daily) daily from 12 0/7 weeks and/or start of enrollment (whichever is later), and continue until 36 weeks gestational age, after which enoxaparin will be discontinued.
  arm group label: Control Group
  arm group type: No Intervention
  description: Participants in this group will have standard care as usual, with no additional medications.
  intervention type: Drug
  intervention name: Lovenox 40mg
  description: Enoxaparin is a blood thinner. It is approved for use in the prevention of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness; inpatient treatment of acute DVT with or without pulmonary embolism; outpatient treatment of acute DVT without pulmonary embolism; Prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction; treatment of acute ST-segment elevation myocardial infarction(STEMI) managed medically or with subsequent percutaneous coronary intervention. The use of Lovenox has been shown to be safe, and it has also been used widely off-label in pregnancy.
  arm group label: Enoxaparin Group
  other name: Enoxaparin
  criteria: 
  gender: All
  gender based: Yes
  gender description: This study will specifically recruit patients who are pregnant, and we anticipate that they will primarily be of female sex.
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Sunitha Suresh
  role: Principal Investigator
  affiliation: NorthShore University HealthSystem
  last name: Sunitha Suresh
  phone: (847) 570-2860
  email: SSuresh@northshore.org
  last name: Olivert Mbah
  phone: (847) 570 - 2243
  email: OMbah@northshore.org
  responsible party type: Principal Investigator
  investigator affiliation: NorthShore University HealthSystem
  investigator full name: Sunitha Suresh
  investigator title: Physician, FPA
  mesh term: Enoxaparin