<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/NCT03011567</url>
  </required_header>
  <id_info>
    <org_study_id>663-15</org_study_id>
    <nct_id>NCT03011567</nct_id>
  </id_info>
  <brief_title>Hypertension In Postpartum Preeclampsia Study</brief_title>
  <acronym>HIPPS</acronym>
  <official_title>A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MemorialCare Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MemorialCare Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs)&#xD;
      administered during the postpartum period influence blood pressure in women with hypertensive&#xD;
      disorders of pregnancy. The study design is a prospective double blinded randomized control&#xD;
      trial with participants randomized to receive postpartum analgesic regimens with and without&#xD;
      NSAIDs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain&#xD;
      in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been&#xD;
      shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been&#xD;
      raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the&#xD;
      potential for increased blood pressure in patients with chronic hypertensive disorders&#xD;
      receiving these agents. Notably, these studies were conducted on patients with longstanding&#xD;
      chronic hypertension, which included males and non-pregnant females, and it is therefore&#xD;
      unclear whether this recommendation is appropriate for patients with transient hypertensive&#xD;
      disorders of pregnancy.&#xD;
&#xD;
      This protocol describes a randomized trial to evaluate whether NSAIDs influence blood&#xD;
      pressure parameters in patients with hypertensive disorders of pregnancy. Patients with&#xD;
      severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women&#xD;
      with mild hypertensive disorders of pregnancy (Mild HDP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</primary_completion_date>
  <phase>N/A</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>Average Mean Arterial Blood Pressure</measure>
    <time_frame>Averaged from all blood pressures measured through study completion, an average of 3 days</time_frame>
    <description>Primary outcome for HDP-Mild Study Group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with at least one episode of severe blood pressure postpartum (systolic &gt;=160 or diastolic &gt;=105mmHg) during inpatient postpartum hospitalization</measure>
    <time_frame>Through study completion, an average of 3 days</time_frame>
    <description>Primary outcome for HDP- Severe Study Group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay</measure>
    <time_frame>Through study completion, an average of 3 days</time_frame>
    <description>Pain control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient Blood Pressure Measurement</measure>
    <time_frame>3 days after discharge from the hospital</time_frame>
    <description>Outpatient postpartum blood pressure measurement within 3 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction/Side Effects</measure>
    <time_frame>Through study completion, an average of 3 days</time_frame>
    <description>Patient satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Through study completion, an average of 3 days</time_frame>
    <description>Length of Hospital Stay after delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diuresis</measure>
    <time_frame>Through study completion, an average of 3 days</time_frame>
    <description>Hourly urine output</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Hypertension, Pregnancy-Induced</condition>
  <arm_group>
    <arm_group_label>Severe HDP- NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will be assigned a postpartum analgesic regimen with ibuprofen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild HDP- NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will be assigned a postpartum analgesic regimen with ibuprofen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe HDP- No NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will be assigned a postpartum analgesic regimen with acetaminophen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild HDP- No NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will be assigned a postpartum analgesic regimen with acetaminophen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Participants will receive acetaminophen for postpartum mild pain relief</description>
    <arm_group_label>Mild HDP- No NSAID</arm_group_label>
    <arm_group_label>Severe HDP- No NSAID</arm_group_label>
    <other_name>Tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>Participants will receive ibuprofen for postpartum mild pain relief</description>
    <arm_group_label>Mild HDP- NSAID</arm_group_label>
    <arm_group_label>Severe HDP- NSAID</arm_group_label>
    <other_name>Motrin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Delivery occurred at equal to or greater than 24 0/7 weeks gestational age&#xD;
&#xD;
          -  Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine&#xD;
             practice) or Obstetric Clinic resident services&#xD;
&#xD;
          -  Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:&#xD;
&#xD;
          -  Gestational hypertension&#xD;
&#xD;
          -  Preeclampsia without severe features&#xD;
&#xD;
          -  Preeclampsia with severe features&#xD;
&#xD;
          -  Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome&#xD;
&#xD;
          -  Eclampsia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic hypertension or documentation of elevated blood pressures before&#xD;
             20 weeks gestational age.&#xD;
&#xD;
          -  Severe hypertension: Patients with at least one severe blood pressure measurement&#xD;
             (systolic &gt;160mmHg or diastolic &gt;105mmHg) prior to randomization&#xD;
&#xD;
          -  Renal dysfunction (Serum creatinine measurement &gt;1.3mg/dL during the current&#xD;
             pregnancy)&#xD;
&#xD;
          -  Low platelet count (recorded measurement &lt;50,000 during hospital admission)&#xD;
&#xD;
          -  Significant liver dysfunction (AST or ALT &gt;500)&#xD;
&#xD;
          -  Known sensitivities to ibuprofen or acetaminophen&#xD;
&#xD;
          -  Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine&#xD;
             prophylaxis of venous thromboembolism is acceptable)&#xD;
&#xD;
          -  Postpartum hemorrhage requiring transfusion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer McNulty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Long Beach Memorial Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miller Children and Women Hospital Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postpartum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 11, 2022</submitted>
    <returned>December 9, 2022</returned>
    <submitted>March 7, 2023</submitted>
    <returned>April 4, 2023</returned>
    <submitted>July 13, 2023</submitted>
    <returned>August 1, 2023</returned>
  </pending_results>
  <!-- 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/NCT03011567
org study id: 663-15
nct id: NCT03011567
lead sponsor: 
has dmc: Yes
This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs)
      administered during the postpartum period influence blood pressure in women with hypertensive
      disorders of pregnancy. The study design is a prospective double blinded randomized control
      trial with participants randomized to receive postpartum analgesic regimens with and without
      NSAIDs.
Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain
      in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been
      shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been
      raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the
      potential for increased blood pressure in patients with chronic hypertensive disorders
      receiving these agents. Notably, these studies were conducted on patients with longstanding
      chronic hypertension, which included males and non-pregnant females, and it is therefore
      unclear whether this recommendation is appropriate for patients with transient hypertensive
      disorders of pregnancy.

      This protocol describes a randomized trial to evaluate whether NSAIDs influence blood
      pressure parameters in patients with hypertensive disorders of pregnancy. Patients with
      severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women
      with mild hypertensive disorders of pregnancy (Mild HDP).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Average Mean Arterial Blood Pressure
time frame: Averaged from all blood pressures measured through study completion, an average of 3 days
description: Primary outcome for HDP-Mild Study Group
measure: Proportion of participants with at least one episode of severe blood pressure postpartum (systolic >=160 or diastolic >=105mmHg) during inpatient postpartum hospitalization
time frame: Through study completion, an average of 3 days
description: Primary outcome for HDP- Severe Study Group
measure: Wong-Baker Facial Grimace Pain Scale Scores During Inpatient Postpartum Hospital Stay
time frame: Through study completion, an average of 3 days
description: Pain control
measure: Outpatient Blood Pressure Measurement
time frame: 3 days after discharge from the hospital
description: Outpatient postpartum blood pressure measurement within 3 days after discharge
measure: Patient Satisfaction/Side Effects
time frame: Through study completion, an average of 3 days
description: Patient satisfaction
measure: Length of Hospital Stay
time frame: Through study completion, an average of 3 days
description: Length of Hospital Stay after delivery
measure: Diuresis
time frame: Through study completion, an average of 3 days
description: Hourly urine output
arm group label: Severe HDP- NSAID
arm group type: Experimental
description: This arm will be assigned a postpartum analgesic regimen with ibuprofen.
arm group label: Mild HDP- NSAID
arm group type: Experimental
description: This arm will be assigned a postpartum analgesic regimen with ibuprofen.
arm group label: Severe HDP- No NSAID
arm group type: Experimental
description: This arm will be assigned a postpartum analgesic regimen with acetaminophen.
arm group label: Mild HDP- No NSAID
arm group type: Experimental
description: This arm will be assigned a postpartum analgesic regimen with acetaminophen.
intervention type: Drug
intervention name: Acetaminophen
description: Participants will receive acetaminophen for postpartum mild pain relief
arm group label: Mild HDP- No NSAID
arm group label: Severe HDP- No NSAID
other name: Tylenol
intervention type: Drug
intervention name: Ibuprofen
description: Participants will receive ibuprofen for postpartum mild pain relief
arm group label: Mild HDP- NSAID
arm group label: Severe HDP- NSAID
other name: Motrin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer McNulty, MD
role: Principal Investigator
affiliation: Long Beach Memorial Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension
mesh term: Acetaminophen
mesh term: Ibuprofen
sharing ipd: Undecided
submitted: November 11, 2022
returned: December 9, 2022
submitted: March 7, 2023
returned: April 4, 2023
submitted: July 13, 2023
returned: August 1, 2023