<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/NCT03028194</url>
  </required_header>
  <id_info>
    <org_study_id>MHST2014-06</org_study_id>
    <nct_id>NCT03028194</nct_id>
  </id_info>
  <brief_title>Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia</brief_title>
  <official_title>Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Thomas Hospital, Panama</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Thomas Hospital, Panama</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>
      Use of Postpartum uterine curettage in reducing hospitalization time or in improving the&#xD;
      clinical evolution of the patient with preeclampsia/eclampsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters&#xD;
      in patients with preeclampsia or eclampsia.&#xD;
&#xD;
      A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage&#xD;
      (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed&#xD;
      at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">December 11, 2016</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>6 hours</time_frame>
    <description>Arterial blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>12 hours</time_frame>
    <description>Arterial blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>24 hours</time_frame>
    <description>Arterial blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>48 hours</time_frame>
    <description>Arterial Blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).</measure>
    <time_frame>6 hours</time_frame>
    <description>Number of patients with an abnormal laboratory value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).</measure>
    <time_frame>12 hours</time_frame>
    <description>Number of patients with an abnormal laboratory value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of patients with an abnormal laboratory value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).</measure>
    <time_frame>48 hours</time_frame>
    <description>Number of patients with an abnormal laboratory value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seizures</measure>
    <time_frame>48 hours</time_frame>
    <description>Number of participants with the development of seizures after birth.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">442</enrollment>
  <condition>Pre-Eclampsia</condition>
  <condition>Eclampsia</condition>
  <arm_group>
    <arm_group_label>Curettage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Postpartum uterine curettage performed immediately after delivery of the placenta.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No procedure performed after delivery of the placenta.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Curettage</intervention_name>
    <description>Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.</description>
    <arm_group_label>Curettage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>No procedure after delivery of the placenta</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age 24 weeks or more.&#xD;
&#xD;
          -  Preeclampsia/eclampsia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy or seizures previous to pregnancy.&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Heart disease&#xD;
&#xD;
          -  Liver disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osvaldo Reyes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Saint Thomas Hospital, Panama</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Thomas H</name>
      <address>
        <city>Panama</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Thomas Maternity Hospital</name>
      <address>
        <city>Panama</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Panama</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Thomas Hospital, Panama</investigator_affiliation>
    <investigator_full_name>Osvaldo A. Reyes T.</investigator_full_name>
    <investigator_title>Head of the Research Department</investigator_title>
  </responsible_party>
  <keyword>Pre-eclampsia</keyword>
  <keyword>Eclampsia</keyword>
  <keyword>Postpartum uterine curettage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</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/NCT03028194
org study id: MHST2014-06
nct id: NCT03028194
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Use of Postpartum uterine curettage in reducing hospitalization time or in improving the
      clinical evolution of the patient with preeclampsia/eclampsia.
To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters
      in patients with preeclampsia or eclampsia.

      A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage
      (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed
      at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Systolic and diastolic blood pressure
time frame: 6 hours
description: Arterial blood pressure
measure: Systolic and diastolic blood pressure
time frame: 12 hours
description: Arterial blood pressure
measure: Systolic and diastolic blood pressure
time frame: 24 hours
description: Arterial blood pressure
measure: Systolic and diastolic blood pressure
time frame: 48 hours
description: Arterial Blood pressure
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
time frame: 6 hours
description: Number of patients with an abnormal laboratory value
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
time frame: 12 hours
description: Number of patients with an abnormal laboratory value
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
time frame: 24 hours
description: Number of patients with an abnormal laboratory value
measure: Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
time frame: 48 hours
description: Number of patients with an abnormal laboratory value
measure: Seizures
time frame: 48 hours
description: Number of participants with the development of seizures after birth.
arm group label: Curettage
arm group type: Experimental
description: Postpartum uterine curettage performed immediately after delivery of the placenta.
arm group label: Placebo
arm group type: Placebo Comparator
description: No procedure performed after delivery of the placenta.
intervention type: Procedure
intervention name: Curettage
description: Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.
arm group label: Curettage
intervention type: Procedure
intervention name: Placebo
description: No procedure after delivery of the placenta
arm group label: Placebo
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: No
last name: Osvaldo Reyes, MD
role: Study Chair
affiliation: Saint Thomas Hospital, Panama
facility: 
facility: 
country: Panama
responsible party type: Principal Investigator
investigator affiliation: Saint Thomas Hospital, Panama
investigator full name: Osvaldo A. Reyes T.
investigator title: Head of the Research Department
mesh term: Pre-Eclampsia
mesh term: Eclampsia
sharing ipd: No