<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/NCT02978976</url>
  </required_header>
  <id_info>
    <org_study_id>A22102016</org_study_id>
    <nct_id>NCT02978976</nct_id>
  </id_info>
  <brief_title>Effect of Antenatal Steroid on Pulmonary Artery Blood Flow</brief_title>
  <official_title>The Effect of Maternal Antenatal Steroid Administration on the Blood Flow Through the Pulmonary Artery in the Term Fetus; a Randomized Control Double Blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the effect of administering antenatal steroids in term&#xD;
      fetuses on the blood flow in the fetal pulmonary artery, and to correlate these findings with&#xD;
      clinical data obtained after birth documenting respiratory disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After internal review board approval, 126 consecutive patients attending the antenatal care&#xD;
      clinic of Kasr Alainy Hospital, part of Cairo university hospitals will be recruited in this&#xD;
      study. All patients will sign informed consent.&#xD;
&#xD;
      Patients included in the study will be 20-38 years of age, have an indication for elective&#xD;
      caesarean section. Patients will be excluded if they are hypertensive, diabetic or have any&#xD;
      disorder that may be aggravated by administration of steroids, women with systemic infection&#xD;
      including tuberculosis or sepsis, any fetal congenital anomalies (affecting the fetal heart,&#xD;
      lungs, and circulation), history of rupture membranes, or suspected chorioamnionitis,&#xD;
      intrauterine growth retardation (IUGR), and intrauterine fetal demise (IUFD).&#xD;
&#xD;
      Patients will be randomized on 37 weeks and 6 days gestation by the nurse attending the&#xD;
      clinic using a computer generated randomization table, and a closed envelope system will be&#xD;
      used. Patients will be equally divided into two groups. Patients in group (A) will receive&#xD;
      two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA)&#xD;
      intramuscularly (IM) 24 hours apart, while group (B) patients will receive a saline placebo&#xD;
      injection in the same regimen.&#xD;
&#xD;
      Ultrasound examination will be done where all patients will lie down in a semi-recumbent&#xD;
      position, and the ultrasound will be performed by an expert ultrasonographer, with expert&#xD;
      training in fetal echocardiography. The ultrasound specialist will be blinded to which study&#xD;
      arm the patients belongs. The abdominal probe of the ultrasound machine (voluson730;&#xD;
      kretz,Zipf,Austria) will be placed so that the fetal chest will be in a transverse section,&#xD;
      giving us the four chamber view of the fetal heart. The color Doppler will then be switched&#xD;
      on, and the fetal pulmonary artery will be identified. The measurements will be taken from&#xD;
      the middle segment of the pulmonary artery just after the first bifurcation of the pulmonary&#xD;
      branch (just after crossing the aortic arch). We will obtain our measurements from either the&#xD;
      right or left pulmonary arteries, whichever is easier according to fetal position, as there&#xD;
      is no difference between the values obtained from either according to the work done by&#xD;
      Rasanen et al.&#xD;
&#xD;
      The pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the&#xD;
      acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after&#xD;
      recruitment, just before the administration of the drug (betamethasone / placebo), 24 hours&#xD;
      after the last dose, and on the day of elective Cs. Caesarean section will be performed 7&#xD;
      days after the last dose of betamethasone, and a senior neonatologist will attend the birth,&#xD;
      document Apgar score, and any neonatal respiratory distress.&#xD;
&#xD;
      A sample size was calculated where the difference in the mean pulsatility index (PI) before&#xD;
      and after administration of antenatal steroids for the middle segment of the fetal pulmonary&#xD;
      artery was 0.42 in a previous study by Bartha et al, and the standard deviation was set as&#xD;
      0.79. The Type I error probability was set at 0.05, and the power at 80%. This gave us 57&#xD;
      patients in each arm, and allowing for dropout rate of 10%, 63 patients will be recruited in&#xD;
      each arm of the study, as the ratio between both study and control was 1:1. PS Power and&#xD;
      Sample size Calculations software, Versionv2.1.30 for MS Windows, was used to calculate&#xD;
      sample size Dupont and Vanderbilt, USA).&#xD;
    </textblock>
  </detailed_description>
  <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">May 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in the mean doppler parameters between the study groups before and after the drug administration ( compare means of doppler reading between both groups using t-test)</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presense of respiratory disorders in neonate (yes/no)</measure>
    <time_frame>8 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">126</enrollment>
  <condition>Neonatal Respiratory Distress</condition>
  <arm_group>
    <arm_group_label>betamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive two doses of 12mg betamethasone, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug (betamethasone), 24 hours after the last dose, and on the day of elective Cs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>will receive saline injection placebo, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug ( placebo), 24 hours after the last dose, and on the day of elective Cs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betamethasone</intervention_name>
    <description>will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart.</description>
    <arm_group_label>betamethasone</arm_group_label>
    <other_name>Dipropfos</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>saline placebo injection in the same regimen.</description>
    <arm_group_label>Saline</arm_group_label>
    <other_name>NaCl 0.9</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for elective caesarean section.&#xD;
&#xD;
          -  37weeks +6days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertensive&#xD;
&#xD;
          -  diabetic&#xD;
&#xD;
          -  any disorder that may be aggravated by administration of steroids&#xD;
&#xD;
          -  women with systemic infection including tuberculosis or sepsis&#xD;
&#xD;
          -  any fetal congenital anomalies (affecting the fetal heart, lungs, and circulation)&#xD;
&#xD;
          -  history of rupture membranes, or suspected chorioamnionitis&#xD;
&#xD;
          -  intrauterine growth retardation (IUGR)&#xD;
&#xD;
          -  intrauterine fetal demise (IUFD).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>28 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Kamel, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer Of obstetrics and gynecology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed M Kamel, M.D.</last_name>
    <phone>00201120022332</phone>
    <email>dr.ahmed.m.kamel@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emad Salah, M.D.</last_name>
    <email>emadsalah148@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>11562</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed M KameL, M.D</last_name>
      <phone>01120022332</phone>
      <email>dr.ahmed.m.kamel@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Bartha JL, Largo-Heinrich M, Machado MJ, Gonzalez-Bugatto F, Hervias-Vivancos B. Effects of antenatal betamethasone on human fetal branch pulmonary artery flow velocity waveforms. Fetal Diagn Ther. 2008;23(1):46-53. doi: 10.1159/000109226. Epub 2007 Oct 9.</citation>
    <PMID>17934298</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed M.Kamel</investigator_full_name>
    <investigator_title>Lecturer of Obstetrtics &amp; gynecology</investigator_title>
  </responsible_party>
  <keyword>RDS</keyword>
  <keyword>Doppler on fetal pulmonary artery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>yes</ipd_description>
  </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/NCT02978976
org study id: A22102016
nct id: NCT02978976
lead sponsor: 
has dmc: No
The aim of this study is to determine the effect of administering antenatal steroids in term
      fetuses on the blood flow in the fetal pulmonary artery, and to correlate these findings with
      clinical data obtained after birth documenting respiratory disorders.
After internal review board approval, 126 consecutive patients attending the antenatal care
      clinic of Kasr Alainy Hospital, part of Cairo university hospitals will be recruited in this
      study. All patients will sign informed consent.

      Patients included in the study will be 20-38 years of age, have an indication for elective
      caesarean section. Patients will be excluded if they are hypertensive, diabetic or have any
      disorder that may be aggravated by administration of steroids, women with systemic infection
      including tuberculosis or sepsis, any fetal congenital anomalies (affecting the fetal heart,
      lungs, and circulation), history of rupture membranes, or suspected chorioamnionitis,
      intrauterine growth retardation (IUGR), and intrauterine fetal demise (IUFD).

      Patients will be randomized on 37 weeks and 6 days gestation by the nurse attending the
      clinic using a computer generated randomization table, and a closed envelope system will be
      used. Patients will be equally divided into two groups. Patients in group (A) will receive
      two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA)
      intramuscularly (IM) 24 hours apart, while group (B) patients will receive a saline placebo
      injection in the same regimen.

      Ultrasound examination will be done where all patients will lie down in a semi-recumbent
      position, and the ultrasound will be performed by an expert ultrasonographer, with expert
      training in fetal echocardiography. The ultrasound specialist will be blinded to which study
      arm the patients belongs. The abdominal probe of the ultrasound machine (voluson730;
      kretz,Zipf,Austria) will be placed so that the fetal chest will be in a transverse section,
      giving us the four chamber view of the fetal heart. The color Doppler will then be switched
      on, and the fetal pulmonary artery will be identified. The measurements will be taken from
      the middle segment of the pulmonary artery just after the first bifurcation of the pulmonary
      branch (just after crossing the aortic arch). We will obtain our measurements from either the
      right or left pulmonary arteries, whichever is easier according to fetal position, as there
      is no difference between the values obtained from either according to the work done by
      Rasanen et al.

      The pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the
      acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after
      recruitment, just before the administration of the drug (betamethasone / placebo), 24 hours
      after the last dose, and on the day of elective Cs. Caesarean section will be performed 7
      days after the last dose of betamethasone, and a senior neonatologist will attend the birth,
      document Apgar score, and any neonatal respiratory distress.

      A sample size was calculated where the difference in the mean pulsatility index (PI) before
      and after administration of antenatal steroids for the middle segment of the fetal pulmonary
      artery was 0.42 in a previous study by Bartha et al, and the standard deviation was set as
      0.79. The Type I error probability was set at 0.05, and the power at 80%. This gave us 57
      patients in each arm, and allowing for dropout rate of 10%, 63 patients will be recruited in
      each arm of the study, as the ratio between both study and control was 1:1. PS Power and
      Sample size Calculations software, Versionv2.1.30 for MS Windows, was used to calculate
      sample size Dupont and Vanderbilt, USA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: changes in the mean doppler parameters between the study groups before and after the drug administration ( compare means of doppler reading between both groups using t-test)
time frame: 1 week
measure: Presense of respiratory disorders in neonate (yes/no)
time frame: 8 days
arm group label: betamethasone
arm group type: Experimental
description: will receive two doses of 12mg betamethasone, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug (betamethasone), 24 hours after the last dose, and on the day of elective Cs.
arm group label: Saline
arm group type: Placebo Comparator
description: will receive saline injection placebo, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug ( placebo), 24 hours after the last dose, and on the day of elective Cs.
intervention type: Drug
intervention name: Betamethasone
description: will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart.
arm group label: betamethasone
other name: Dipropfos
intervention type: Drug
intervention name: saline
description: saline placebo injection in the same regimen.
arm group label: Saline
other name: NaCl 0.9
criteria: 
gender: Female
minimum age: 28 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Kamel, M.D.
role: Principal Investigator
affiliation: Lecturer Of obstetrics and gynecology
last name: Ahmed M Kamel, M.D.
phone: 00201120022332
email: dr.ahmed.m.kamel@gmail.com
last name: Emad Salah, M.D.
email: emadsalah148@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Bartha JL, Largo-Heinrich M, Machado MJ, Gonzalez-Bugatto F, Hervias-Vivancos B. Effects of antenatal betamethasone on human fetal branch pulmonary artery flow velocity waveforms. Fetal Diagn Ther. 2008;23(1):46-53. doi: 10.1159/000109226. Epub 2007 Oct 9.
PMID: 17934298
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Ahmed M.Kamel
investigator title: Lecturer of Obstetrtics & gynecology
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Distress Syndrome
mesh term: Betamethasone
sharing ipd: Yes
ipd description: yes