<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/NCT03779451</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/191/18</org_study_id>
    <nct_id>NCT03779451</nct_id>
  </id_info>
  <brief_title>Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa</brief_title>
  <official_title>Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic 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 Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone&#xD;
      Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with&#xD;
      Placenta Previa&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a randomized open-label clinical trial conducted at a tertiary university&#xD;
      hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between&#xD;
      January 2019 and March 2022. The authors will include women who asymptomatic pregnant women&#xD;
      with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three&#xD;
      groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular&#xD;
      dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group&#xD;
      III(control group). In each group, Follow-up visits were performed every week then admission&#xD;
      was done at 36 weeks at our university hospital. Scheduled caesarian section was done at&#xD;
      completed 37 weeks unless otherwise required.&#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">April 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 randomized controlled study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>An open-label randomized controlled study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>number of patient delivered before 37 weeks</measure>
    <time_frame>2 month</time_frame>
    <description>calculation the number of patients delivered before 37 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of episodes of antepartum hemorrhage</measure>
    <time_frame>2 month</time_frame>
    <description>calculating the mean number of episodes of antepartum hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission for significant antepartum hemorrhage</measure>
    <time_frame>2 month</time_frame>
    <description>Number of patients requiring hospital admission for significant antepartum hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Birth weight</measure>
    <time_frame>one hours post operative</time_frame>
    <description>measure Neonatal Birth weight in kilograms</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">400</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 26-28 week and up to 37-weeks' gestation or delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vaginal progesterone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>17-OHPC</intervention_name>
    <description>received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 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>vaginal progesterone</intervention_name>
    <description>vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery</description>
    <arm_group_label>vaginal progesterone</arm_group_label>
    <other_name>Active Comparator</other_name>
    <other_name>Cyclogest</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age 26-28 weeks of gestation.&#xD;
&#xD;
          -  Definite and reliable diagnosis of placenta previa (defined as the presence of a&#xD;
             placenta within 2 cm of the internal os), using a transvaginal ultrasound scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancies.&#xD;
&#xD;
          -  Women at high risk of preterm labor e.g. history of spontaneous preterm labor or&#xD;
             preterm prelabour rupture of the membranes (PPROM).&#xD;
&#xD;
          -  Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent&#xD;
             -intervention and delivery.&#xD;
&#xD;
          -  Women who have been maintained on progestin therapy since early pregnancy for whatever&#xD;
             reason.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women with 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, md</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>vaginal progesterone</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_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/NCT03779451
org study id: aswu/191/18
nct id: NCT03779451
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone
      Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with
      Placenta Previa
The study will be a randomized open-label clinical trial conducted at a tertiary university
      hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between
      January 2019 and March 2022. The authors will include women who asymptomatic pregnant women
      with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three
      groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular
      dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group
      III(control group). In each group, Follow-up visits were performed every week then admission
      was done at 36 weeks at our university hospital. Scheduled caesarian section was done at
      completed 37 weeks unless otherwise required.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled study
primary purpose: Prevention
masking: None (Open Label)
masking description: An open-label randomized controlled study
measure: number of patient delivered before 37 weeks
time frame: 2 month
description: calculation the number of patients delivered before 37 weeks
measure: number of episodes of antepartum hemorrhage
time frame: 2 month
description: calculating the mean number of episodes of antepartum hemorrhage
measure: Hospital admission for significant antepartum hemorrhage
time frame: 2 month
description: Number of patients requiring hospital admission for significant antepartum hemorrhage
measure: Neonatal Birth weight
time frame: one hours post operative
description: measure Neonatal Birth weight in kilograms
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 26-28 week and up to 37-weeks' gestation or delivery
arm group label: vaginal progesterone
arm group type: Active Comparator
description: vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery
arm group label: control group
arm group type: No Intervention
description: Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone.
intervention type: Drug
intervention name: 17-OHPC
description: received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 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: vaginal progesterone
description: vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery
arm group label: vaginal progesterone
other name: Active Comparator
other name: Cyclogest
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women with 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, md
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
mesh term: Progesterone
sharing ipd: Undecided