<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/NCT02221830</url>
  </required_header>
  <id_info>
    <org_study_id>13-2738</org_study_id>
    <secondary_id>UL1TR001082</secondary_id>
    <nct_id>NCT02221830</nct_id>
  </id_info>
  <brief_title>Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)</brief_title>
  <acronym>PHP3</acronym>
  <official_title>Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in&#xD;
      patients with pre-eclampsia (PE)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this study is to evaluate the efficacy of postpartum 24 hour oxytocin&#xD;
      infusion as a prevention-oriented strategy to reduce blood loss in patients with&#xD;
      pre-eclampsia (PE) in a blinded, placebo controlled, randomized controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">July 17, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 2019</primary_completion_date>
  <phase>Early Phase 1</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Postpartum hematocrit</measure>
    <time_frame>24 hours postpartum</time_frame>
    <description>Postpartum hematocrit (collected 24 hours after delivery unless patient receives blood transfusion, then pre-transfusion hematocrit will be used)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary postpartum hemorrhage</measure>
    <time_frame>Before discharge from hospital</time_frame>
    <description>Considered to be &gt;500ml with vaginal deliveries,or, &gt;1000ml with cesarean sections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss at delivery</measure>
    <time_frame>Before discharge from hospital</time_frame>
    <description>Estimated blood loss at delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum blood loss</measure>
    <time_frame>24 hours postpartum</time_frame>
    <description>Postpartum blood loss: 24hrs postpartum, as measured by pad counts and weights.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal Saline (standard of care)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>normal saline + oxytocin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>This intervention utilizes a Placebo Camparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. vaginal or cesarean delivery at a gestational age greater than or equal to 20 weeks&#xD;
             gestational age;&#xD;
&#xD;
          2. diagnosis of preeclampsia (PE defined using standard definitions based on the ACOG&#xD;
             bulletin and the NIH Working Group on High Blood Pressure in Pregnancy (i.e., a&#xD;
             systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater&#xD;
             than 90 mm Hg on at least 2 occasions at least 6 hours apart after 20 weeks gestation&#xD;
             and proteinuria of &gt; 300mg per 24 hour period or &gt; 1+ on dipstick).&#xD;
&#xD;
          3. patients treated with magnesium sulfate for 24 hours post partum at 2g/hr (standard of&#xD;
             care when deemed appropriate by clinician for seizure prophylaxis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. abnormal placentation (previa, accreta, etc)&#xD;
&#xD;
          2. antenatal hemorrhage&#xD;
&#xD;
          3. contraindication to oxytocin&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Hermesch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Clinical and Translational Research Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</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>Pre-Eclampsia</mesh_term>
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_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/NCT02221830
org study id: 13-2738
secondary id: UL1TR001082
nct id: NCT02221830
lead sponsor: 
has dmc: No
is fda regulated device: No
Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in
      patients with pre-eclampsia (PE)
The overall goal of this study is to evaluate the efficacy of postpartum 24 hour oxytocin
      infusion as a prevention-oriented strategy to reduce blood loss in patients with
      pre-eclampsia (PE) in a blinded, placebo controlled, randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Evaluation of Postpartum hematocrit
time frame: 24 hours postpartum
description: Postpartum hematocrit (collected 24 hours after delivery unless patient receives blood transfusion, then pre-transfusion hematocrit will be used)
measure: Primary postpartum hemorrhage
time frame: Before discharge from hospital
description: Considered to be >500ml with vaginal deliveries,or, >1000ml with cesarean sections.
measure: Estimated blood loss at delivery
time frame: Before discharge from hospital
description: Estimated blood loss at delivery
measure: Postpartum blood loss
time frame: 24 hours postpartum
description: Postpartum blood loss: 24hrs postpartum, as measured by pad counts and weights.
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal Saline (standard of care)
arm group label: Treatment
arm group type: Experimental
description: normal saline + oxytocin
intervention type: Drug
intervention name: Oxytocin
description: Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)
arm group label: Treatment
intervention type: Drug
intervention name: Placebo
description: This intervention utilizes a Placebo Camparator
arm group label: Placebo
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 45 Years
healthy volunteers: No
last name: Amy Hermesch, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin