<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/NCT03031353</url>
  </required_header>
  <id_info>
    <org_study_id>AinShamsU103</org_study_id>
    <nct_id>NCT03031353</nct_id>
  </id_info>
  <brief_title>Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity</brief_title>
  <official_title>Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neonatal respiratory distress may occur in either term or preterm newborns with a higher&#xD;
      relative risk in preterm, and whether born vaginally or through caesarean section, but in a&#xD;
      higher percentage after elective caesarean section whose rate is rising.&#xD;
&#xD;
      Prostaglandins may be given about one hour before an elective caesarean section after&#xD;
      excluding the presence of contraindication to their use to decrease the neonatal respiratory&#xD;
      diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that&#xD;
      occurs frequently in children who had previously TTN will diminish.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The need for admission to neonatal intensive care unit (NICU)</measure>
    <time_frame>first 24 hours after delivery</time_frame>
    <description>Number of newborns admitted to NICU for respiratory morbidity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>APGAR score below 6 at 5 minute</measure>
    <time_frame>5 minutes after delivery</time_frame>
    <description>number of newborns delivered with APGAR score below 6 at 5 minutes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>neonatal mortality</measure>
    <time_frame>first month after delivery</time_frame>
    <description>number of neonates died from respiratory morbidity with one month of delivery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Transient Tachypnea Newborn</condition>
  <condition>Cesarean Delivery Affecting Fetus</condition>
  <arm_group>
    <arm_group_label>Misoprostol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage</description>
    <arm_group_label>Misoprostol</arm_group_label>
    <other_name>Mesotac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>placebos tablet will be given before elective Cesarean sections</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years or more.&#xD;
&#xD;
          -  Term singleton pregnancy (38 - 38+6 weeks gestation).&#xD;
&#xD;
          -  Planned for elective transverse lower segment caesarean section with an indication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy,&#xD;
             severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.&#xD;
&#xD;
          -  Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to&#xD;
             prostaglandins or specifically for misoprostol.&#xD;
&#xD;
          -  Psychological problem or mental disease that renders the patient not able to&#xD;
             understand the nature, scope, and sequences of the study.&#xD;
&#xD;
          -  Pregnancies with known foetal malformation/s or chromosomal aberration.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed M kotb, MD</last_name>
    <phone>01008681999</phone>
    <phone_ext>0020</phone_ext>
    <email>ahmedmkotp@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ahmed DR kotb, MD</last_name>
    <phone>1008681999</phone>
    <phone_ext>0020</phone_ext>
    <email>ahmedmkotp@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine, Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <state>Al Qahirah</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ahmed kotb, MD</last_name>
      <phone>2001008681999</phone>
      <email>ahmedmkotp@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>ebtihal dr eltaieb, MD</last_name>
      <phone>1004711414</phone>
      <phone_ext>0020</phone_ext>
      <email>ahmedmkotp@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>May 24, 2018</last_update_submitted>
  <last_update_submitted_qc>May 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed El Kotb Abdel Fattah</investigator_full_name>
    <investigator_title>Dr., Lecturer in obstertics and gynecology, Ain Shams University Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachypnea</mesh_term>
    <mesh_term>Transient Tachypnea of the Newborn</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</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/NCT03031353
org study id: AinShamsU103
nct id: NCT03031353
lead sponsor: 
has dmc: Yes
Neonatal respiratory distress may occur in either term or preterm newborns with a higher
      relative risk in preterm, and whether born vaginally or through caesarean section, but in a
      higher percentage after elective caesarean section whose rate is rising.

      Prostaglandins may be given about one hour before an elective caesarean section after
      excluding the presence of contraindication to their use to decrease the neonatal respiratory
      diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that
      occurs frequently in children who had previously TTN will diminish.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The need for admission to neonatal intensive care unit (NICU)
time frame: first 24 hours after delivery
description: Number of newborns admitted to NICU for respiratory morbidity
measure: APGAR score below 6 at 5 minute
time frame: 5 minutes after delivery
description: number of newborns delivered with APGAR score below 6 at 5 minutes
measure: neonatal mortality
time frame: first month after delivery
description: number of neonates died from respiratory morbidity with one month of delivery
arm group label: Misoprostol
arm group type: Experimental
description: After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
arm group label: Placebo
arm group type: Active Comparator
description: After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized
intervention type: Drug
intervention name: Misoprostol
description: Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
arm group label: Misoprostol
other name: Mesotac
intervention type: Drug
intervention name: Placebos
description: placebos tablet will be given before elective Cesarean sections
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Ahmed M kotb, MD
phone: 01008681999
phone ext: 0020
email: ahmedmkotp@hotmail.com
last name: ahmed DR kotb, MD
phone: 1008681999
phone ext: 0020
email: ahmedmkotp@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Mohamed El Kotb Abdel Fattah
investigator title: Dr., Lecturer in obstertics and gynecology, Ain Shams University Hospital
mesh term: Tachypnea
mesh term: Transient Tachypnea of the Newborn
mesh term: Misoprostol
sharing ipd: No