<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/NCT04407975</url>
  </required_header>
  <id_info>
    <org_study_id>642020</org_study_id>
    <nct_id>NCT04407975</nct_id>
  </id_info>
  <brief_title>Effect of Single Dose Antenatal Betamethasone on Neonatal Respiratory Morbidity After Elective Cesarean</brief_title>
  <official_title>Effect of Single Dose Antenatal Betamethasone on the Incidence of Neonatal Respiratory Morbidity After Elective Cesarean Section at Term: A Prospective Double Blinded Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing elective C-section will be randomized into two groups. The first group&#xD;
      will receive one dose of Betamethasone at least 24 hours before scheduled C-section. The&#xD;
      second group will receive placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective double blinded randomized clinical trial. Patients will be randomized&#xD;
      into two groups. Group A will receive one dose of Betamethasone at least 24 hours before&#xD;
      scheduled C-section. Group B will receive placebo. The maternal and neonatal outcomes will be&#xD;
      studied in order to assess the effect of Betamethasone on respiratory morbidity of the&#xD;
      newborn infant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 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>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with respiratory morbidity</measure>
    <time_frame>at birth</time_frame>
    <description>Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Admission to Neonatal Intensive Care Unit (NICU)</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Reasons for NICU admission and length of stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Respiratory Morbidity</condition>
  <arm_group>
    <arm_group_label>Betamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 14 mg (2 ml) intramuscular betamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive an equivalent volume of normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Betamethasone</intervention_name>
    <description>A single injection will be administered to the patient at least 24 hours before undergoing C-section. This injection will be prepared in the hospital's pharmacy to contain betamethasone</description>
    <arm_group_label>Betamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with singleton or multiple gestation,&#xD;
&#xD;
          -  between 37 and 40 weeks of pregnancy (as calculated from the first day of the last&#xD;
             menstrual period)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any medical problem that could affect fetal well-being;&#xD;
&#xD;
          -  evidence of intrauterine infection,&#xD;
&#xD;
          -  oligohydramnios,&#xD;
&#xD;
          -  fetal congenital malformations,&#xD;
&#xD;
          -  preeclampsia,&#xD;
&#xD;
          -  maternal hypertension,&#xD;
&#xD;
          -  severe fetal rhesus sensitization,&#xD;
&#xD;
          -  antepartum hemorrhage,&#xD;
&#xD;
          -  Intrauterine growth restriction&#xD;
&#xD;
          -  preterm rupture of membranes&#xD;
&#xD;
          -  preterm delivery&#xD;
&#xD;
          -  previously received antenatal steroids less than one month ago&#xD;
&#xD;
          -  those who decline to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manal Hubeish, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makassed General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manal Hubeish, MD</last_name>
    <phone>+9611636297</phone>
    <email>drmanalhubeishhusari@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manal Hubesih, MD</last_name>
      <phone>+9611636000</phone>
      <phone_ext>6297</phone_ext>
      <email>drmanalhubesihhusari@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Manal Hubeish</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04407975
org study id: 642020
nct id: NCT04407975
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients undergoing elective C-section will be randomized into two groups. The first group
      will receive one dose of Betamethasone at least 24 hours before scheduled C-section. The
      second group will receive placebo.
This is a prospective double blinded randomized clinical trial. Patients will be randomized
      into two groups. Group A will receive one dose of Betamethasone at least 24 hours before
      scheduled C-section. Group B will receive placebo. The maternal and neonatal outcomes will be
      studied in order to assess the effect of Betamethasone on respiratory morbidity of the
      newborn infant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of patients with respiratory morbidity
time frame: at birth
description: Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score
measure: Admission to Neonatal Intensive Care Unit (NICU)
time frame: up to 2 weeks
description: Reasons for NICU admission and length of stay
arm group label: Betamethasone
arm group type: Experimental
description: Patients will receive 14 mg (2 ml) intramuscular betamethasone
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive an equivalent volume of normal saline
intervention type: Other
intervention name: Betamethasone
description: A single injection will be administered to the patient at least 24 hours before undergoing C-section. This injection will be prepared in the hospital's pharmacy to contain betamethasone
arm group label: Betamethasone
intervention type: Other
intervention name: Placebo
description: A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 17 Years
maximum age: 45 Years
healthy volunteers: No
last name: Manal Hubeish, MD
role: Principal Investigator
affiliation: Makassed General Hospital
last name: Manal Hubeish, MD
phone: +9611636297
email: drmanalhubeishhusari@gmail.com
facility: 
status: Recruiting
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Manal Hubeish
investigator title: Principal Investigator
mesh term: Betamethasone