<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/NCT03824119</url>
  </required_header>
  <id_info>
    <org_study_id>HS-17-00959</org_study_id>
    <nct_id>NCT03824119</nct_id>
  </id_info>
  <brief_title>Postpartum NSAIDS and Maternal Hypertension</brief_title>
  <official_title>Effect of Non-steroidal Anti-inflammatory Use on Blood Pressure in Women With Hypertensive Disorders of Pregnancy: A Randomized Open Label Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies have suggested that NSAID use causes an increase in blood pressure. Further,&#xD;
      blood pressure elevation has been noted in women with pregnancy related hypertensive disease&#xD;
      during the postpartum period. NSAIDs remain part of standard postpartum care in women with&#xD;
      hypertensive disease. The objective of this study is to determine whether postpartum standard&#xD;
      care withholding NSAID use is associated with a clinically significant reduction in&#xD;
      postpartum hypertension in women with pregnancy induced hypertension. The investigators&#xD;
      hypothesize that women with pregnancy induced hypertensive disease will be half as likely to&#xD;
      have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum.&#xD;
&#xD;
      This study is an open label randomized trial of women with antepartum hypertension. Women&#xD;
      will be randomized to receive standard postpartum care or standard postpartum care without&#xD;
      NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period&#xD;
      will begin at the time of delivery and will end at the time of hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to determine whether the withholding of NSAID use is&#xD;
      associated with a clinically significant decrease in postpartum hypertension in women with&#xD;
      antepartum hypertension. The investigators are interested in whether the use of NSAIDs&#xD;
      elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or&#xD;
      diastolic parameters) more frequently in hypertensive women. The investigators hypothesize&#xD;
      that among participants with hypertensive disease associated with pregnancy, those who have&#xD;
      NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to&#xD;
      have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared&#xD;
      to participants receiving standard care that includes NSAIDs (control arm).&#xD;
&#xD;
      This trial is a randomized, open label study investigating the effect of NSAID use on blood&#xD;
      pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or&#xD;
      pregnancy induced hypertension (PIH). The experimental group in this study will be women&#xD;
      randomized to withholding NSAIDs during the study period, as women with hypertension&#xD;
      routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension&#xD;
      [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be&#xD;
      enrolled antepartum and will be separated into two groups by the route of delivery: vaginal&#xD;
      vs. cesarean delivery. Participants in the control arm will be assigned to receive standard&#xD;
      care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm&#xD;
      will be assigned to receive standard care with NSAIDs withheld in the postpartum period for&#xD;
      the duration of hospitalization. The intervention period will last approximately 2-4 days and&#xD;
      will conclude at the time of hospital discharge.&#xD;
&#xD;
      Blood pressure measurements will be obtained and recorded routinely in the postpartum period&#xD;
      until hospital discharge. More frequent measurements may be performed in the event of severe&#xD;
      blood pressure elevations at the discretion of the provider and treating clinical team.&#xD;
      Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care.&#xD;
      Additional laboratory evaluations will be performed at the discretion of the provider. In&#xD;
      addition to blood pressure measurement, pain scale scores will be recorded daily using a&#xD;
      Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP&#xD;
      160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes&#xD;
      (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure,&#xD;
      death) will be documented and abstracted from the medical record.&#xD;
&#xD;
      A power calculation to estimate the appropriate number of subjects needed to detect a&#xD;
      difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power&#xD;
      demonstrates that approximately 100 subjects per group (50 in the experimental group and 50&#xD;
      in the control group) will be needed for each delivery route tested (vaginal and cesarean).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Anticipated">December 11, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 11, 2022</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants with blood pressure elevation</measure>
    <time_frame>24 hours postpartum</time_frame>
    <description>Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with blood pressure elevation</measure>
    <time_frame>48, 72 and 96 hours postpartum</time_frame>
    <description>Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with eclamptic Seizure</measure>
    <time_frame>Through study completion, up to 6 weeks postpartum</time_frame>
    <description>Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with stroke</measure>
    <time_frame>Through study completion, up to 6 weeks postpartum</time_frame>
    <description>New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initiation of anti-hypertensive medication</measure>
    <time_frame>Randomization through hospital discharge, an average of 3-7 days</time_frame>
    <description>Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain numerical rating scale (NRS) score</measure>
    <time_frame>Randomization through hospital discharge, measured daily, an average of 3-7 days</time_frame>
    <description>Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with renal failure</measure>
    <time_frame>Through study completion, up to 6 weeks postpartum</time_frame>
    <description>Creatinine &gt;1.1 or doubled</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with pulmonary edema</measure>
    <time_frame>Through study completion, up to 6 weeks postpartum</time_frame>
    <description>Evidence of lung infiltrates on chest radiograph or CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who die</measure>
    <time_frame>From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Through hospital discharge, an average of 3-7 days</time_frame>
    <description>Number of days from delivery to hospital discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Preeclampsia</condition>
  <condition>Gestational Hypertension</condition>
  <condition>Superimposed Preeclampsia</condition>
  <condition>Chronic Hypertension in Obstetric Context</condition>
  <arm_group>
    <arm_group_label>Standard Postpartum Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Postpartum Care without NSAIDs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen 600 mg</intervention_name>
    <description>Standard postpartum care (including administration of NSAIDs)</description>
    <arm_group_label>Standard Postpartum Care</arm_group_label>
    <other_name>Standard Postpartum Care</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Postpartum Care without NSAIDs</intervention_name>
    <description>NSAID administration will be withheld from this group.</description>
    <arm_group_label>Standard Postpartum Care without NSAIDs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women 18 years or older delivering at LAC/USC Hospital&#xD;
&#xD;
          -  Delivery occurring at or after 20 weeks gestation&#xD;
&#xD;
          -  Diagnosis of antenatal hypertensive disorder: gestational hypertension, preeclampsia&#xD;
             without severe features, preeclampsia with severe features, superimposed preeclampsia,&#xD;
             eclampsia, chronic hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HELLP Syndrome&#xD;
&#xD;
          -  Renal dysfunction (Serum Creatinine &gt;1.1 in current pregnancy)&#xD;
&#xD;
          -  Known liver disease&#xD;
&#xD;
          -  Low platelet count (&lt;50,000 during hospital admission)&#xD;
&#xD;
          -  Known sensitivity or allergy to ibuprofen or acetaminophen&#xD;
&#xD;
          -  Use of therapeutic doses of anticoagulation&#xD;
&#xD;
          -  Postpartum hemorrhage requiring blood transfusion&#xD;
&#xD;
          -  Neonate with platelet disorder or thrombocytopenia in breastfeeding mother&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Sasso, MD</last_name>
    <phone>(323)409-3306</phone>
    <email>elizabeth.sasso@med.usc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ian O'Donnell</last_name>
    <phone>(323)409-3306</phone>
    <email>ian.odonnell@med.usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>LA County Hospital/University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sasso, MD</last_name>
      <phone>323-409-3306</phone>
      <email>elizabeth.sasso@med.usc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pope JE, Anderson JJ, Felson DT. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med. 1993 Feb 22;153(4):477-84.</citation>
    <PMID>8435027</PMID>
  </reference>
  <reference>
    <citation>Johnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med. 1994 Aug 15;121(4):289-300. doi: 10.7326/0003-4819-121-4-199408150-00011.</citation>
    <PMID>8037411</PMID>
  </reference>
  <reference>
    <citation>Curhan GC, Willett WC, Rosner B, Stampfer MJ. Frequency of analgesic use and risk of hypertension in younger women. Arch Intern Med. 2002 Oct 28;162(19):2204-8. doi: 10.1001/archinte.162.19.2204.</citation>
    <PMID>12390063</PMID>
  </reference>
  <reference>
    <citation>Makris A, Thornton C, Hennessy A. Postpartum hypertension and nonsteroidal analgesia. Am J Obstet Gynecol. 2004 Feb;190(2):577-8. doi: 10.1016/j.ajog.2003.08.030.</citation>
    <PMID>14981414</PMID>
  </reference>
  <reference>
    <citation>Schoenfeld A, Freedman S, Hod M, Ovadia Y. Antagonism of antihypertensive drug therapy in pregnancy by indomethacin? Am J Obstet Gynecol. 1989 Nov;161(5):1204-5. doi: 10.1016/0002-9378(89)90666-2.</citation>
    <PMID>2589441</PMID>
  </reference>
  <reference>
    <citation>Wasden SW, Ragsdale ES, Chasen ST, Skupski DW. Impact of non-steroidal anti-inflammatory drugs on hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Oct;4(4):259-63. doi: 10.1016/j.preghy.2014.06.001. Epub 2014 Jul 11.</citation>
    <PMID>26104814</PMID>
  </reference>
  <reference>
    <citation>Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.</citation>
    <PMID>28885417</PMID>
  </reference>
  <reference>
    <citation>Vigil-De Gracia P, Solis V, Ortega N. Ibuprofen versus acetaminophen as a post-partum analgesic for women with severe pre-eclampsia: randomized clinical study. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1279-1282. doi: 10.1080/14767058.2016.1210599. Epub 2016 Aug 2.</citation>
    <PMID>27384376</PMID>
  </reference>
  <reference>
    <citation>Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.</citation>
    <PMID>3769407</PMID>
  </reference>
  <reference>
    <citation>Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.</citation>
    <PMID>24150027</PMID>
  </reference>
  <reference>
    <citation>Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.</citation>
    <PMID>21963308</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Richard H. Lee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <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>Ibuprofen</mesh_term>
  </intervention_browse>
  <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/NCT03824119
org study id: HS-17-00959
nct id: NCT03824119
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Previous studies have suggested that NSAID use causes an increase in blood pressure. Further,
      blood pressure elevation has been noted in women with pregnancy related hypertensive disease
      during the postpartum period. NSAIDs remain part of standard postpartum care in women with
      hypertensive disease. The objective of this study is to determine whether postpartum standard
      care withholding NSAID use is associated with a clinically significant reduction in
      postpartum hypertension in women with pregnancy induced hypertension. The investigators
      hypothesize that women with pregnancy induced hypertensive disease will be half as likely to
      have blood pressure elevation of 150/100 mmHg in the first 24 hours postpartum.

      This study is an open label randomized trial of women with antepartum hypertension. Women
      will be randomized to receive standard postpartum care or standard postpartum care without
      NSAIDs. Blood pressure measurements and patient outcomes will be recorded. The study period
      will begin at the time of delivery and will end at the time of hospital discharge.
The objective of this study is to determine whether the withholding of NSAID use is
      associated with a clinically significant decrease in postpartum hypertension in women with
      antepartum hypertension. The investigators are interested in whether the use of NSAIDs
      elevates blood pressure to greater than or equal to 150/100 mmHg (by either systolic or
      diastolic parameters) more frequently in hypertensive women. The investigators hypothesize
      that among participants with hypertensive disease associated with pregnancy, those who have
      NSAIDs withheld from standard postpartum care (experimental arm) will be half as likely to
      have an increase of blood pressure of 150/100 mmHg in the first 24 hours postpartum compared
      to participants receiving standard care that includes NSAIDs (control arm).

      This trial is a randomized, open label study investigating the effect of NSAID use on blood
      pressure during the immediate postpartum period in women with chronic hypertension (cHTN) or
      pregnancy induced hypertension (PIH). The experimental group in this study will be women
      randomized to withholding NSAIDs during the study period, as women with hypertension
      routinely receive NSAIDs postpartum. Women with a diagnosis of pregnancy induced hypertension
      [gestational hypertension (gHTN), preeclampsia, superimposed preeclampsia, ] or cHTN will be
      enrolled antepartum and will be separated into two groups by the route of delivery: vaginal
      vs. cesarean delivery. Participants in the control arm will be assigned to receive standard
      care, which includes NSAIDs (ketorolac, ibuprofen) and participants in the experimental arm
      will be assigned to receive standard care with NSAIDs withheld in the postpartum period for
      the duration of hospitalization. The intervention period will last approximately 2-4 days and
      will conclude at the time of hospital discharge.

      Blood pressure measurements will be obtained and recorded routinely in the postpartum period
      until hospital discharge. More frequent measurements may be performed in the event of severe
      blood pressure elevations at the discretion of the provider and treating clinical team.
      Complete Blood Count (CBC) on postpartum Day 1 will be performed as part of standard care.
      Additional laboratory evaluations will be performed at the discretion of the provider. In
      addition to blood pressure measurement, pain scale scores will be recorded daily using a
      Numeric Pain Scale Score. Initiation of anti-hypertensive medication, severe hypertension (BP
      160/110 mmHg), treatment with magnesium sulfate and adverse maternal outcomes
      (cerebrovascular accident, congestive heart failure, pulmonary edema, eclamptic seizure,
      death) will be documented and abstracted from the medical record.

      A power calculation to estimate the appropriate number of subjects needed to detect a
      difference of 30% in the primary outcome, with an alpha level of 0.05 and 80% power
      demonstrates that approximately 100 subjects per group (50 in the experimental group and 50
      in the control group) will be needed for each delivery route tested (vaginal and cesarean).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of participants with blood pressure elevation
time frame: 24 hours postpartum
description: Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
measure: Proportion of participants with blood pressure elevation
time frame: 48, 72 and 96 hours postpartum
description: Incidence of Systolic Blood Pressure of 150 mmHg or Diastolic Blood Pressure of 100 mmHg or above
measure: Number of participants with eclamptic Seizure
time frame: Through study completion, up to 6 weeks postpartum
description: Documented occurrence of new onset generalized tonic-clonic seizure(s) or coma in a woman with preeclampsia
measure: Number of participants with stroke
time frame: Through study completion, up to 6 weeks postpartum
description: New onset neurologic deficit associated with neuroimaging (CT scan or MRI) evidence of brain infarction or bleeding
measure: Initiation of anti-hypertensive medication
time frame: Randomization through hospital discharge, an average of 3-7 days
description: Provider documentation of initiation of anti-hypertensive medication (e.g. nifedipine, labetalol)
measure: Pain numerical rating scale (NRS) score
time frame: Randomization through hospital discharge, measured daily, an average of 3-7 days
description: Numerical pain scale score 0-10; 0= no pain and 10=worst possible pain; total score reported
measure: Number of participants with renal failure
time frame: Through study completion, up to 6 weeks postpartum
description: Creatinine >1.1 or doubled
measure: Number of participants with pulmonary edema
time frame: Through study completion, up to 6 weeks postpartum
description: Evidence of lung infiltrates on chest radiograph or CT scan
measure: Number of participants who die
time frame: From the date of randomization through date of death from any cause, assessed up to 6 weeks postpartum
measure: Length of hospital stay
time frame: Through hospital discharge, an average of 3-7 days
description: Number of days from delivery to hospital discharge
arm group label: Standard Postpartum Care
arm group type: Active Comparator
description: Subjects will receive NSAIDs (e.g. ibuprofen, ketorolac) for routine postpartum pain management.
arm group label: Standard Postpartum Care without NSAIDs
arm group type: Active Comparator
description: Subjects will receive standard postpartum care without NSAID administration for pain management. Acetaminophen or narcotics will be substituted for ibuprofen as indicated by provider.
intervention type: Drug
intervention name: Ibuprofen 600 mg
description: Standard postpartum care (including administration of NSAIDs)
arm group label: Standard Postpartum Care
other name: Standard Postpartum Care
intervention type: Other
intervention name: Standard Postpartum Care without NSAIDs
description: NSAID administration will be withheld from this group.
arm group label: Standard Postpartum Care without NSAIDs
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Lee, MD
role: Principal Investigator
affiliation: University of Southern California
last name: Elizabeth Sasso, MD
phone: (323)409-3306
email: elizabeth.sasso@med.usc.edu
last name: Ian O'Donnell
phone: (323)409-3306
email: ian.odonnell@med.usc.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Pope JE, Anderson JJ, Felson DT. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med. 1993 Feb 22;153(4):477-84.
PMID: 8435027
citation: Johnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med. 1994 Aug 15;121(4):289-300. doi: 10.7326/0003-4819-121-4-199408150-00011.
PMID: 8037411
citation: Curhan GC, Willett WC, Rosner B, Stampfer MJ. Frequency of analgesic use and risk of hypertension in younger women. Arch Intern Med. 2002 Oct 28;162(19):2204-8. doi: 10.1001/archinte.162.19.2204.
PMID: 12390063
citation: Makris A, Thornton C, Hennessy A. Postpartum hypertension and nonsteroidal analgesia. Am J Obstet Gynecol. 2004 Feb;190(2):577-8. doi: 10.1016/j.ajog.2003.08.030.
PMID: 14981414
citation: Schoenfeld A, Freedman S, Hod M, Ovadia Y. Antagonism of antihypertensive drug therapy in pregnancy by indomethacin? Am J Obstet Gynecol. 1989 Nov;161(5):1204-5. doi: 10.1016/0002-9378(89)90666-2.
PMID: 2589441
citation: Wasden SW, Ragsdale ES, Chasen ST, Skupski DW. Impact of non-steroidal anti-inflammatory drugs on hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Oct;4(4):259-63. doi: 10.1016/j.preghy.2014.06.001. Epub 2014 Jul 11.
PMID: 26104814
citation: Viteri OA, England JA, Alrais MA, Lash KA, Villegas MI, Ashimi Balogun OA, Chauhan SP, Sibai BM. Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women With Preeclampsia With Severe Features. Obstet Gynecol. 2017 Oct;130(4):830-835. doi: 10.1097/AOG.0000000000002247.
PMID: 28885417
citation: Vigil-De Gracia P, Solis V, Ortega N. Ibuprofen versus acetaminophen as a post-partum analgesic for women with severe pre-eclampsia: randomized clinical study. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1279-1282. doi: 10.1080/14767058.2016.1210599. Epub 2016 Aug 2.
PMID: 27384376
citation: Walters BN, Thompson ME, Lee A, de Swiet M. Blood pressure in the puerperium. Clin Sci (Lond). 1986 Nov;71(5):589-94. doi: 10.1042/cs0710589.
PMID: 3769407
citation: Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
PMID: 24150027
citation: Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012 Jun;206(6):470-5. doi: 10.1016/j.ajog.2011.09.002. Epub 2011 Sep 16.
PMID: 21963308
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Richard H. Lee
investigator title: Associate Professor
mesh term: Pre-Eclampsia
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension
mesh term: Ibuprofen
sharing ipd: No