<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/NCT03026686</url>
  </required_header>
  <id_info>
    <org_study_id>24998</org_study_id>
    <nct_id>NCT03026686</nct_id>
  </id_info>
  <brief_title>Postpartum Readmission</brief_title>
  <official_title>Postpartum Preeclampsia Readmission</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>
      This is a retrospective chart review of women who labored and delivered in a single health&#xD;
      care center. From that large group the investigators will evaluate women who were re-admitted&#xD;
      in the post partum period for a hypertensive disorder. The study will also look at&#xD;
      &quot;Controls,&quot; a group of women with similar risk factors but did not require readmission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder&#xD;
      affects approximately 10 percent of pregnancies worldwide constituting one of the greatest&#xD;
      causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is&#xD;
      defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is&#xD;
      considered severe if blood pressure is increased substantially or symptoms of end-organ&#xD;
      damage (including fetal growth restriction) occur. There is no single reliable,&#xD;
      cost-effective screening test for preeclampsia, and there are no well-established measures&#xD;
      for primary prevention. Management before the onset of labor includes close monitoring of&#xD;
      maternal and fetal status. Management during delivery includes seizure prophylaxis with&#xD;
      magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the&#xD;
      ultimate treatment.&#xD;
&#xD;
      Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches,&#xD;
      right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of&#xD;
      eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness&#xD;
&#xD;
      Current obstetric treatment in the United States has resulted in a shift of eclampsia toward&#xD;
      the postpartum period, with most cases being seen as late post partum. During the post partum&#xD;
      period a patient's blood pressure peaks around 3-6 days post delivery, however most patients&#xD;
      are discharged home by 48 hours. This results in re-admission to the hospital for some women.&#xD;
      The investigator's goal is to review and evaluate women who have been readmitted for a&#xD;
      preeclampsia or eclampsia episode during the post partum period to assess if there are&#xD;
      preceding signs or symptoms leading to her re admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient personel&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>hypertension</measure>
    <time_frame>1 year</time_frame>
    <description>compare these two groups during the antepartum period, labor, delivery and post partum course for possible preceding signs (blood pressures) of those at risk for re admission for hypertensive disorders.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">335</enrollment>
  <condition>Postpartum Hypertension</condition>
  <arm_group>
    <arm_group_label>readmit</arm_group_label>
    <description>women who were re-admitted in the post partum period for a hypertensive disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>women with similar risk factors but did not require readmission</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women postpartum who are re-admitted for hypertension disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who labored and delivered at a single hospital Readmitted (within 6 weeks post&#xD;
             partum (PP) or less)to the hospital for hypertension disorder, with or without&#xD;
             hypertension (HTN in pregnancy), gestational hypertension (gHTN), pre eclampsia&#xD;
             (PreE), severe pre eclampsia (sPreE), HELLP (&quot;HELLP&quot; is an abbreviation of the three&#xD;
             main features of the syndrome: Hemolysis. Elevated Liver enzymes. Low Platelet&#xD;
             count.).&#xD;
&#xD;
        Controls Group with PreE, not readmitted or No PreE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospital readmission for other complications.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Goldkamp, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>October 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>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_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/NCT03026686
org study id: 24998
nct id: NCT03026686
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective chart review of women who labored and delivered in a single health
      care center. From that large group the investigators will evaluate women who were re-admitted
      in the post partum period for a hypertensive disorder. The study will also look at
      "Controls," a group of women with similar risk factors but did not require readmission.
Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder
      affects approximately 10 percent of pregnancies worldwide constituting one of the greatest
      causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is
      defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is
      considered severe if blood pressure is increased substantially or symptoms of end-organ
      damage (including fetal growth restriction) occur. There is no single reliable,
      cost-effective screening test for preeclampsia, and there are no well-established measures
      for primary prevention. Management before the onset of labor includes close monitoring of
      maternal and fetal status. Management during delivery includes seizure prophylaxis with
      magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the
      ultimate treatment.

      Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches,
      right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of
      eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness

      Current obstetric treatment in the United States has resulted in a shift of eclampsia toward
      the postpartum period, with most cases being seen as late post partum. During the post partum
      period a patient's blood pressure peaks around 3-6 days post delivery, however most patients
      are discharged home by 48 hours. This results in re-admission to the hospital for some women.
      The investigator's goal is to review and evaluate women who have been readmitted for a
      preeclampsia or eclampsia episode during the post partum period to assess if there are
      preceding signs or symptoms leading to her re admission.
observational model: Cohort
time perspective: Retrospective
measure: hypertension
time frame: 1 year
description: compare these two groups during the antepartum period, labor, delivery and post partum course for possible preceding signs (blood pressures) of those at risk for re admission for hypertensive disorders.
arm group label: readmit
description: women who were re-admitted in the post partum period for a hypertensive disorder
arm group label: Controls
description: women with similar risk factors but did not require readmission
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
last name: Jennifer Goldkamp, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Jennifer Goldkamp, MD
investigator title: Principal investigator
mesh term: Hypertension
sharing ipd: No