<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/NCT03779438</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/189/18</org_study_id>
    <nct_id>NCT03779438</nct_id>
  </id_info>
  <brief_title>17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa</brief_title>
  <official_title>Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate&#xD;
      (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with&#xD;
      Placenta Previa&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most authors report an increased risk of bleeding with advancing gestation among women with&#xD;
      placenta previa.&#xD;
&#xD;
      The American College of Obstetricians and Gynecologists (ACOG) and the Society for&#xD;
      Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent&#xD;
      spontaneous preterm birth.&#xD;
&#xD;
      Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are&#xD;
      at risk for neurological, respiratory, and gastrointestinal complications. So, it is&#xD;
      therefore very important to try to prolong the pregnancy without increasing the risk of&#xD;
      emergent delivery in cases with placenta previa. The authors hypothesized that a&#xD;
      pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy&#xD;
      outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled&#xD;
      cesarean section women with a placenta previa.&#xD;
&#xD;
      The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the&#xD;
      prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with&#xD;
      avoids of an emergent CD which affects the maternal outcome and prevents prematurity which&#xD;
      affects the prenatal outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>
    <intervention_model_description>A Double-Blind Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A Double-Blind Randomized Clinical Trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the duration of prolongation of pregnancy from the time of enrollment to the time of delivery</measure>
    <time_frame>6 weeks</time_frame>
    <description>measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>apgar score</measure>
    <time_frame>5 minutes postpartum</time_frame>
    <description>measure apgar score from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of patients with postpartum hemorrhage</measure>
    <time_frame>24 hours post operative</time_frame>
    <description>calculation the number of patients with postpartum hemorrhage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Placenta Previa</condition>
  <arm_group>
    <arm_group_label>17-OHPC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo to 17-OHPC</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>17-OHPC</intervention_name>
    <description>patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery</description>
    <arm_group_label>17-OHPC</arm_group_label>
    <other_name>Active Comparator</other_name>
    <other_name>cidolut depot</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to 17-OHPC</intervention_name>
    <description>patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery</description>
    <arm_group_label>placebo to 17-OHPC</arm_group_label>
    <other_name>Placebo Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated gestational age: between 24 weeks and 37 week's gestation&#xD;
&#xD;
          -  Confirmed Placenta previa; either major or minor degrees.&#xD;
&#xD;
          -  Placenta previa with preterm uterine contractions or with a history of at least single&#xD;
             attack of mild vaginal bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe attack of bleeding requiring an immediate intervention.&#xD;
&#xD;
          -  Fetal heart rates instability or non-reassuring tracing&#xD;
&#xD;
          -  Intrauterine fetal death or major fetal anomalies.&#xD;
&#xD;
          -  If associated with abruptio placentae&#xD;
&#xD;
          -  Patients with known bleeding disorders or on anticoagulant therapy&#xD;
&#xD;
          -  Patients with severe medical disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women with symptomatic placenta previa</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hany f sallam, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aswan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hany f sallam</last_name>
    <phone>01022336052</phone>
    <phone_ext>002</phone_ext>
    <email>hany.farouk@aswu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aswan University</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>hany f sallam, md</last_name>
      <phone>01092440504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.ed.eg</email>
    </contact>
    <contact_backup>
      <last_name>Nahla w Shady, md</last_name>
      <phone>1019240504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cesarean section</keyword>
  <keyword>placenta previa</keyword>
  <keyword>antepartum hemorrhage</keyword>
  <keyword>17-alpha-Hydroxyprogesterone caproate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Previa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03779438
org study id: aswu/189/18
nct id: NCT03779438
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate
      (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with
      Placenta Previa
Most authors report an increased risk of bleeding with advancing gestation among women with
      placenta previa.

      The American College of Obstetricians and Gynecologists (ACOG) and the Society for
      Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent
      spontaneous preterm birth.

      Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are
      at risk for neurological, respiratory, and gastrointestinal complications. So, it is
      therefore very important to try to prolong the pregnancy without increasing the risk of
      emergent delivery in cases with placenta previa. The authors hypothesized that a
      pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy
      outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled
      cesarean section women with a placenta previa.

      The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the
      prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with
      avoids of an emergent CD which affects the maternal outcome and prevents prematurity which
      affects the prenatal outcome.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A Double-Blind Randomized Clinical Trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A Double-Blind Randomized Clinical Trial
measure: the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
time frame: 6 weeks
description: measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery
measure: apgar score
time frame: 5 minutes postpartum
description: measure apgar score from 0 to 10
measure: the number of patients with postpartum hemorrhage
time frame: 24 hours post operative
description: calculation the number of patients with postpartum hemorrhage
arm group label: 17-OHPC
arm group type: Active Comparator
description: patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
arm group label: placebo to 17-OHPC
arm group type: Placebo Comparator
description: patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
intervention type: Drug
intervention name: 17-OHPC
description: patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
arm group label: 17-OHPC
other name: Active Comparator
other name: cidolut depot
intervention type: Drug
intervention name: placebo to 17-OHPC
description: patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
arm group label: placebo to 17-OHPC
other name: Placebo Comparator
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women with symptomatic placenta previa
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: hany f sallam, md
role: Principal Investigator
affiliation: Aswan University Hospital
last name: hany f sallam
phone: 01022336052
phone ext: 002
email: hany.farouk@aswu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: Principal Investigator
mesh term: Placenta Previa
sharing ipd: Undecided