<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/NCT03298802</url>
  </required_header>
  <id_info>
    <org_study_id>16-0280</org_study_id>
    <nct_id>NCT03298802</nct_id>
  </id_info>
  <brief_title>Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide</brief_title>
  <official_title>Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or&#xD;
      gestational hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and&#xD;
      relapse of preeclampsia or gestational hypertension on readmission rates, need for additional&#xD;
      antihypertensive therapy and number of triage visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>double-blind randomized placebo controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Randomization will be performed by a person not involved in the clinical trial using a computer random list of numbers generated using STATA (StataCorp 14.0, Dallas, TX). This list of random number assignments will be kept secure and sent directly to the investigational drug service (IDS), who will be responsible for the allocation and dispensing of the medications</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of readmission and/or triage visits</measure>
    <time_frame>1-6 weeks postpartum</time_frame>
    <description>Any visit in the hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for additional antihypertensive therapy</measure>
    <time_frame>1-6 weeks postpartum</time_frame>
    <description>Requiring additional antihypertensive agents in the postpartum period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>1-6 weeks postpartum</time_frame>
    <description>Days that patient required to be in-house in the postpartum period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Additional doses of anti-hypertensive therapy</measure>
    <time_frame>1-6 weeks postpartum</time_frame>
    <description>Addition of total doses that patient received in the postpartum period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elevation of blood pressure &gt;150/90</measure>
    <time_frame>1-6 weeks postpartum</time_frame>
    <description>Hypertension definition in the postpartum period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe composite maternal morbidity</measure>
    <time_frame>1-6 weeks postpartum</time_frame>
    <description>o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of resources</measure>
    <time_frame>1-6 weeks postpartum</time_frame>
    <description>hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1-6 weeks Postpartum</time_frame>
    <description>Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">612</enrollment>
  <condition>Pre-Eclampsia</condition>
  <condition>Gestational Hypertension</condition>
  <condition>Superimposed Pre-Eclampsia</condition>
  <condition>Hypertension, Pregnancy-Induced</condition>
  <condition>Postpartum Pregnancy-Induced Hypertension</condition>
  <condition>Postpartum Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Hydrochlorothiazide 50mg Tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide 50mg Tablet</intervention_name>
    <description>Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.</description>
    <arm_group_label>Hydrochlorothiazide 50mg Tablet</arm_group_label>
    <other_name>HydroDIURIL, Microzide, Esidrix, Oretic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Tablet</intervention_name>
    <description>Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum</description>
    <arm_group_label>Placebo Tablet</arm_group_label>
    <other_name>sugar pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maternal age ≥ 18 years and &lt;50 years.&#xD;
&#xD;
          -  Diagnosis of gestational hypertension* or preeclampsia^ at any time during pregnancy,&#xD;
             labor or postpartum.&#xD;
&#xD;
               -  defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm&#xD;
                  Hg or greater, or both) or ^ defines as new-onset hypertension plus new-onset&#xD;
                  proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as&#xD;
                  hypertension in association with thrombocytopenia (platelet count less than&#xD;
                  100,000/microliter), impaired liver function (elevated blood levels of liver&#xD;
                  transaminases to twice the normal concentration), the new development of renal&#xD;
                  insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of&#xD;
                  serum creatinine in the absence of other renal disease), pulmonary edema, or&#xD;
                  new-onset cerebral or visual disturbances.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject requiring antihypertensive therapy at time of screening.&#xD;
&#xD;
          -  Planned discharge with oral anti-hypertensive medication.&#xD;
&#xD;
          -  Contraindication to hydrochlorothiazide (advanced renal failure or anuria,&#xD;
             hypersensitivity to sulfonamides).&#xD;
&#xD;
          -  Subject not able to follow up postpartum.&#xD;
&#xD;
          -  Lactose intolerance.&#xD;
&#xD;
          -  Pre-gestational diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women after delivery of neonate</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Saad, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Megan C Shepherd, M.D.</last_name>
    <phone>409-772-0312</phone>
    <email>mcshephe@UTMB.EDU</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ashley Salazar, RN</last_name>
    <phone>409-772-0312</phone>
    <email>assalaza@utmb.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. David's North Austin Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Gleason, RN</last_name>
      <phone>512-821-2540</phone>
      <email>Caroline.Gleason@hcahealthcare.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Saad, MD</last_name>
      <phone>409-747-6646</phone>
      <email>afsaad@utmb.edu</email>
    </contact>
    <contact_backup>
      <last_name>Megan C Shepherd, MD</last_name>
      <email>mcshephe@utmb.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>readmission</keyword>
  <keyword>triage visit for pregnancy related hypertension</keyword>
  <keyword>hydrochlorothiazide</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>
    <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>Hydrochlorothiazide</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/NCT03298802
org study id: 16-0280
nct id: NCT03298802
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or
      gestational hypertension.
To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and
      relapse of preeclampsia or gestational hypertension on readmission rates, need for additional
      antihypertensive therapy and number of triage visits.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double-blind randomized placebo controlled clinical trial
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: Randomization will be performed by a person not involved in the clinical trial using a computer random list of numbers generated using STATA (StataCorp 14.0, Dallas, TX). This list of random number assignments will be kept secure and sent directly to the investigational drug service (IDS), who will be responsible for the allocation and dispensing of the medications
measure: Rate of readmission and/or triage visits
time frame: 1-6 weeks postpartum
description: Any visit in the hospital
measure: Need for additional antihypertensive therapy
time frame: 1-6 weeks postpartum
description: Requiring additional antihypertensive agents in the postpartum period
measure: Length of hospital stay
time frame: 1-6 weeks postpartum
description: Days that patient required to be in-house in the postpartum period
measure: Total Additional doses of anti-hypertensive therapy
time frame: 1-6 weeks postpartum
description: Addition of total doses that patient received in the postpartum period
measure: Elevation of blood pressure >150/90
time frame: 1-6 weeks postpartum
description: Hypertension definition in the postpartum period
measure: Severe composite maternal morbidity
time frame: 1-6 weeks postpartum
description: o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death
measure: Use of resources
time frame: 1-6 weeks postpartum
description: hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.
measure: Adverse Events
time frame: 1-6 weeks Postpartum
description: Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
arm group label: Hydrochlorothiazide 50mg Tablet
arm group type: Active Comparator
description: Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
arm group label: Placebo Tablet
arm group type: Placebo Comparator
description: Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum
intervention type: Drug
intervention name: Hydrochlorothiazide 50mg Tablet
description: Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
arm group label: Hydrochlorothiazide 50mg Tablet
other name: HydroDIURIL, Microzide, Esidrix, Oretic
intervention type: Drug
intervention name: Placebo Tablet
description: Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum
arm group label: Placebo Tablet
other name: sugar pill
criteria: 
gender: Female
gender based: Yes
gender description: Women after delivery of neonate
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Antonio Saad, M.D.
role: Principal Investigator
affiliation: UTMB
last name: Megan C Shepherd, M.D.
phone: 409-772-0312
email: mcshephe@UTMB.EDU
last name: Ashley Salazar, RN
phone: 409-772-0312
email: assalaza@utmb.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Eclampsia
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension
mesh term: Hydrochlorothiazide
sharing ipd: No