<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/NCT02989025</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0029</org_study_id>
    <nct_id>NCT02989025</nct_id>
  </id_info>
  <brief_title>Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia</brief_title>
  <acronym>PROGRESS</acronym>
  <official_title>Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Babbette Lamarca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to&#xD;
      mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OBGYN house and attending staff on duty caring for the patient will determine&#xD;
      appropriateness for study inclusion. The treating physician will then immediately contact the&#xD;
      MFM fellow on call and Research Division personnel to facilitate the initiation of study&#xD;
      procedures, including the consent process and baseline blood tests. Once enrolled with&#xD;
      informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and&#xD;
      every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected&#xD;
      at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the&#xD;
      first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs&#xD;
      (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will&#xD;
      also collect information of the mother and newborn while in the hospital and until discharge&#xD;
      including de-identified routine ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of maternal and perinatal outcomes</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of maternal BP trends</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change is being assessed in Maternal Outcomes</measure>
    <time_frame>24 hours</time_frame>
    <description>Assessment of maternal BP trends</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change is being assessed in Maternal Outcomes</measure>
    <time_frame>48 hours</time_frame>
    <description>Assessment of maternal BP trends</description>
  </other_outcome>
  <other_outcome>
    <measure>Change is being assessed in Maternal Outcomes</measure>
    <time_frame>Until delivery</time_frame>
    <description>Assessment of maternal BP trends</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Placental Abruption</measure>
    <time_frame>Baseline until delivery</time_frame>
    <description>Assessment of Placental Abruption</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Pulmonary edema</measure>
    <time_frame>Change from Baseline until delivery</time_frame>
    <description>Assessment of Pulmonary edema</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Acute Kidney Injury</measure>
    <time_frame>Change from Baseline until delivery</time_frame>
    <description>Assessment of Acute Kidney Injury</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of DIC</measure>
    <time_frame>Change from Baseline until delivery</time_frame>
    <description>Assessment of DIC</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of neurological events</measure>
    <time_frame>Change from Baseline until delivery</time_frame>
    <description>Assessment of neurological events</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of laboratory results</measure>
    <time_frame>Change from Baseline until delivery</time_frame>
    <description>Assessment of laboratory results</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Biomarkers</measure>
    <time_frame>Change from Baseline until delivery</time_frame>
    <description>Assessment of Biomarkers</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Infant Weight</measure>
    <time_frame>Delivery</time_frame>
    <description>Assessment of Infant Weight</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of APGAR score</measure>
    <time_frame>Delivery</time_frame>
    <description>Assessment of APGAR score</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of NICU stays</measure>
    <time_frame>Delivery</time_frame>
    <description>Assessment of NICU stays</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Interventricular hemorrhage</measure>
    <time_frame>Delivery</time_frame>
    <description>Assessment of Interventricular hemorrhage</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Respiratory Distress Syndrome</measure>
    <time_frame>Delivery</time_frame>
    <description>Assessment of Respiratory Distress Syndrome</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Necrotizing enterocolitis (NEC)</measure>
    <time_frame>Delivery</time_frame>
    <description>Assessment of Necrotizing enterocolitis (NEC)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>To determine how close the molecular markers are with 17 OHPC added to the management protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>17 OHPC</intervention_name>
    <description>The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeks&#xD;
             gestation when initially evaluated&#xD;
&#xD;
          -  Willing and able to understand study procedures and to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt;33 weeks gestational age or &lt;23 weeks gestation&#xD;
&#xD;
          -  Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC,&#xD;
             pulmonary edema).&#xD;
&#xD;
          -  Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal&#xD;
             heart rate decelerations, minimal to absent fetal heart rate variability).&#xD;
&#xD;
          -  Parameters according to current practice guidelines that exclude a patient from&#xD;
             expectant management include the following:&#xD;
&#xD;
          -  Preterm premature rupture of membranes (PPROM) &gt; 34 weeks gestation;&#xD;
&#xD;
          -  Platelet count &lt; 100,000/microliter (thrombocytopenia) with evidence of HELLP&#xD;
             syndrome;&#xD;
&#xD;
          -  Persistently abnormal hepatic enzyme concentrations (twice or more upper normal&#xD;
             values);&#xD;
&#xD;
          -  Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth&#xD;
             percentile);&#xD;
&#xD;
          -  Severe Oligohydramnios (AFI &lt; 5cm)&#xD;
&#xD;
          -  Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;&#xD;
&#xD;
          -  Recurrent (&gt; 2 readings &gt; 30 minutes apart) severe hypertension despite&#xD;
             antihypertensive therapy;&#xD;
&#xD;
          -  Eclampsia;&#xD;
&#xD;
          -  Pulmonary edema;&#xD;
&#xD;
          -  Abruption placentae;&#xD;
&#xD;
          -  Nonreassuring fetal status during daily testing (biophysical profile &lt;4/10 and/or&#xD;
             recurrent variable or late decelerations);&#xD;
&#xD;
          -  IUFD&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Babbette LaMarca, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missisippi Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Babbette LaMarca, PhD</last_name>
    <phone>(601)815-1430</phone>
    <email>bblamarca@umc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lorena M Amaral, Ph.D.</last_name>
    <email>lmamaral@umc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Winfred L. Wiser Hospital</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Babbette LaMarca, PhD</last_name>
      <phone>601-815-1430</phone>
      <email>bblamarca@umc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Sheila Belk, MSCI</last_name>
      <phone>(601)984-1690</phone>
      <email>sbelk@umc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Mississippi Medical Center</investigator_affiliation>
    <investigator_full_name>Babbette Lamarca</investigator_full_name>
    <investigator_title>Chair and Professor, Pharmacology and Toxicology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-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/NCT02989025
org study id: 2015-0029
nct id: NCT02989025
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to
      mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby
      outcomes.
The OBGYN house and attending staff on duty caring for the patient will determine
      appropriateness for study inclusion. The treating physician will then immediately contact the
      MFM fellow on call and Research Division personnel to facilitate the initiation of study
      procedures, including the consent process and baseline blood tests. Once enrolled with
      informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and
      every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected
      at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the
      first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs
      (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will
      also collect information of the mother and newborn while in the hospital and until discharge
      including de-identified routine ultrasound.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement of maternal and perinatal outcomes
time frame: Baseline
description: Assessment of maternal BP trends
measure: Change is being assessed in Maternal Outcomes
time frame: 24 hours
description: Assessment of maternal BP trends
measure: Change is being assessed in Maternal Outcomes
time frame: 48 hours
description: Assessment of maternal BP trends
measure: Change is being assessed in Maternal Outcomes
time frame: Until delivery
description: Assessment of maternal BP trends
measure: Assessment of Placental Abruption
time frame: Baseline until delivery
description: Assessment of Placental Abruption
measure: Assessment of Pulmonary edema
time frame: Change from Baseline until delivery
description: Assessment of Pulmonary edema
measure: Assessment of Acute Kidney Injury
time frame: Change from Baseline until delivery
description: Assessment of Acute Kidney Injury
measure: Assessment of DIC
time frame: Change from Baseline until delivery
description: Assessment of DIC
measure: Assessment of neurological events
time frame: Change from Baseline until delivery
description: Assessment of neurological events
measure: Assessment of laboratory results
time frame: Change from Baseline until delivery
description: Assessment of laboratory results
measure: Assessment of Biomarkers
time frame: Change from Baseline until delivery
description: Assessment of Biomarkers
measure: Assessment of Infant Weight
time frame: Delivery
description: Assessment of Infant Weight
measure: Assessment of APGAR score
time frame: Delivery
description: Assessment of APGAR score
measure: Assessment of NICU stays
time frame: Delivery
description: Assessment of NICU stays
measure: Assessment of Interventricular hemorrhage
time frame: Delivery
description: Assessment of Interventricular hemorrhage
measure: Assessment of Respiratory Distress Syndrome
time frame: Delivery
description: Assessment of Respiratory Distress Syndrome
measure: Assessment of Necrotizing enterocolitis (NEC)
time frame: Delivery
description: Assessment of Necrotizing enterocolitis (NEC)
arm group label: Experimental
arm group type: Experimental
description: To determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes.
arm group label: Control
arm group type: No Intervention
description: To determine how close the molecular markers are with 17 OHPC added to the management protocol.
intervention type: Drug
intervention name: 17 OHPC
description: The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
arm group label: Experimental
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Babbette LaMarca, PhD
role: Principal Investigator
affiliation: University of Missisippi Medical Center
last name: Babbette LaMarca, PhD
phone: (601)815-1430
email: bblamarca@umc.edu
last name: Lorena M Amaral, Ph.D.
email: lmamaral@umc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Mississippi Medical Center
investigator full name: Babbette Lamarca
investigator title: Chair and Professor, Pharmacology and Toxicology
mesh term: Pre-Eclampsia
sharing ipd: No