<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/NCT03026673</url>
  </required_header>
  <id_info>
    <org_study_id>26975</org_study_id>
    <nct_id>NCT03026673</nct_id>
  </id_info>
  <brief_title>Retrospective Review of NSAIDS in the Postpartum Period</brief_title>
  <official_title>Hypertension and NSAIDS in the Postpartum Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</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>
      Chart review of women who have delivered an infant in a single health care system to&#xD;
      determine if NSAID use increases blood pressures in the postpartum period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common medication used for pain&#xD;
      relief in the postpartum period in the United States. For pain relief of uterine involution,&#xD;
      NSAIDs have shown to be superior to placebo, and equivalent or superior to narcotics. In 2013&#xD;
      the American College of Obstetricians and Gynecologists (ACOG) discouraged the use of NSAIDs&#xD;
      in women with pre-eclampsia due to concerns for inadvertently increasing blood pressure. This&#xD;
      recommendation is based on non-obstetrics literature, which tended to show a small increase&#xD;
      of blood pressures in patients who use NSAIDS. However the literature is mixed, particularly&#xD;
      on ibuprofen which is the most common NSAID used in the postpartum. Of the two meta-analysis&#xD;
      that are commonly referenced, Pope et al found a decrease of -0.3 (+/- 2.57) mmHg in mean&#xD;
      arterial pressure (MAP) in patients with hypertension treated with ibuprofen, and Johnson et&#xD;
      al identified an average of 5mmHg increase in blood pressure with ibuprofen use. A large&#xD;
      study of 18,325 patients who were treated with NSAIDS or COX-2 inhibitors, found an average&#xD;
      of a 2.1 (+/- 0.5) mmHg increase in blood pressure with ibuprofen administration.&#xD;
&#xD;
      There are two articles available in the obstetrics literature on the topic of NSAIDS in women&#xD;
      with hypertension disorders. The first is by Makis et al, and is a case series of six women,&#xD;
      with discussion of two cases. The explanations of hypertension causes are limited and&#xD;
      possible alternate diagnoses are not discussed (6). The second by Wasden et al is a&#xD;
      retrospective study of women who had the diagnosis of severe hypertension disorders in&#xD;
      pregnancy. The patients were matched 2:1 for women exposed to NSAIDs versus those who did not&#xD;
      receive NSAIDs. MAPs were compared, and there was no difference found between the two groups.&#xD;
      This second study is better designed and is likely representative of the true outcome of&#xD;
      NSAID use in pre-eclamptic women, as the general literature shows a small, non-clinically&#xD;
      significant change in blood pressure readings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    staff shortage&#xD;
  </why_stopped>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pain relief</measure>
    <time_frame>1 year</time_frame>
    <description>to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Post Partum Pain</condition>
  <arm_group>
    <arm_group_label>NSAID use</arm_group_label>
    <description>The purpose of this study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NSAID use</intervention_name>
    <description>The purpose of the study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.</description>
    <arm_group_label>NSAID use</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant, All ethnic backgrounds will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  received NSAIDs post delivery for pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Goldkamp, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Mary's Health Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Jennifer Goldkamp, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03026673
org study id: 26975
nct id: NCT03026673
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chart review of women who have delivered an infant in a single health care system to
      determine if NSAID use increases blood pressures in the postpartum period.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common medication used for pain
      relief in the postpartum period in the United States. For pain relief of uterine involution,
      NSAIDs have shown to be superior to placebo, and equivalent or superior to narcotics. In 2013
      the American College of Obstetricians and Gynecologists (ACOG) discouraged the use of NSAIDs
      in women with pre-eclampsia due to concerns for inadvertently increasing blood pressure. This
      recommendation is based on non-obstetrics literature, which tended to show a small increase
      of blood pressures in patients who use NSAIDS. However the literature is mixed, particularly
      on ibuprofen which is the most common NSAID used in the postpartum. Of the two meta-analysis
      that are commonly referenced, Pope et al found a decrease of -0.3 (+/- 2.57) mmHg in mean
      arterial pressure (MAP) in patients with hypertension treated with ibuprofen, and Johnson et
      al identified an average of 5mmHg increase in blood pressure with ibuprofen use. A large
      study of 18,325 patients who were treated with NSAIDS or COX-2 inhibitors, found an average
      of a 2.1 (+/- 0.5) mmHg increase in blood pressure with ibuprofen administration.

      There are two articles available in the obstetrics literature on the topic of NSAIDS in women
      with hypertension disorders. The first is by Makis et al, and is a case series of six women,
      with discussion of two cases. The explanations of hypertension causes are limited and
      possible alternate diagnoses are not discussed (6). The second by Wasden et al is a
      retrospective study of women who had the diagnosis of severe hypertension disorders in
      pregnancy. The patients were matched 2:1 for women exposed to NSAIDs versus those who did not
      receive NSAIDs. MAPs were compared, and there was no difference found between the two groups.
      This second study is better designed and is likely representative of the true outcome of
      NSAID use in pre-eclamptic women, as the general literature shows a small, non-clinically
      significant change in blood pressure readings.
observational model: Cohort
time perspective: Retrospective
measure: pain relief
time frame: 1 year
description: to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period
arm group label: NSAID use
description: The purpose of this study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.
intervention type: Other
intervention name: NSAID use
description: The purpose of the study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.
arm group label: NSAID use
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 12 Years
maximum age: 45 Years
healthy volunteers: No
last name: Jennifer Goldkamp, MD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Jennifer Goldkamp, MD
investigator title: Principal Investigator
sharing ipd: No