<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/NCT03239327</url>
  </required_header>
  <id_info>
    <org_study_id>assiut university women health</org_study_id>
    <nct_id>NCT03239327</nct_id>
  </id_info>
  <brief_title>Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome</brief_title>
  <official_title>Vaginal Misoprostol Before Elective Cesarean Section to Improve Neonatal Respiratory Outcomes . Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Project summary:&#xD;
&#xD;
      Objective: To test the hypothesis that administration of vaginal Misoprostol before elective&#xD;
      cesarean section will improve the neonatal respiratory outcomes in late preterm and early&#xD;
      term neonates through induction of catecholamine surge.&#xD;
&#xD;
      Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university&#xD;
      hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two&#xD;
      hundred and ninety two women will be randomly allocated to receive either 50 micrograms of&#xD;
      Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or&#xD;
      receive nothing (control group; n = 146) .&#xD;
&#xD;
      Main outcome measure: Apgar score at 1 and 5 minutes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology: After a written informed consent obtained, women who are fitting the inclusion&#xD;
      criteria will be randomly allocated using sealed, coded, opaque and sequentially numbered&#xD;
      envelopes containing computer generated random numbers into either the study group or the&#xD;
      control group. For the study group the enrolled women will receive 50 microgram misoprostol&#xD;
      vaginally within 60 minutes before CS. For the control group mothers enrolled will receive&#xD;
      nothing.&#xD;
&#xD;
      Observation and data collection: Cardiotocographic monitoring will be undertaken after&#xD;
      maternal misoprostol administration to detect any evidence of uterine hyperstimulation and&#xD;
      fetal distress.&#xD;
&#xD;
      Ritodrine IV will be used as a tocolytic agent in case of uterine tachysystole. 100 mg of&#xD;
      ritodrine will be added to 500 ml of 0.5% dextrose, the solution will be administered as&#xD;
      following:&#xD;
&#xD;
      5 drops / minute in the 1st 10 minutes. 10 drops / minute in the next 10 minutes then 15&#xD;
      drops / minute . The clinician should adjust the infusion rate so that the pulse rate doesn't&#xD;
      exceed 120b/min and lung bases are free of crepitations.&#xD;
&#xD;
      The surgical and anesthetic teams will be in a state of complete readiness for the ECS from&#xD;
      the time of maternal misoprostol administration after enrollment. Details on maternal&#xD;
      fluid-electrolyte status during ECS will be recorded as maternal fluid overload is reported&#xD;
      to be associated with respiratory distress in the newborn. (SinghiS,Chookang E;1984) blood&#xD;
      loss during and 1 hour after the operation will be estimated.&#xD;
&#xD;
      Maternal data: Patient name, hospital number, age, parity, gestational age, any medical&#xD;
      disorder and indication of CS.&#xD;
&#xD;
      Neonatal observations: delivery room care details will be noted, neonatal heart rate,&#xD;
      respiratory rate, and signs of respiratory distress- for example, grunting, chest wall&#xD;
      retractions, nasal flaring- will be recorded hourly in the postnatal ward for eight hours and&#xD;
      once only at 24 hours of age after delivery. Management of a neonate with respiratory&#xD;
      distress (defined as respiratory rate at rest.60/min and/or signs of respiratory distress)&#xD;
      will be left to the neonatal team. Severity of illness, provisional and final diagnosis, and&#xD;
      outcome (death/discharge home/transfer to other hospital) will be recorded if any neonate&#xD;
      would be admitted to the neonatal intensive care unit for respiratory distress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.</measure>
    <time_frame>During the first 24 hours of life.</time_frame>
    <description>The number of neonates who need Neonatal Intensive Care Unit admission in each study group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">292</enrollment>
  <condition>Neonatal Respiratory Distress</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the study group the enrolled women will receive 50 microgram misoprostol vaginally 60 minutes before CS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For the control group mothers enrolled will receive nothing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <arm_group_label>study group</arm_group_label>
    <other_name>Prostaglandin E1,Cytotec</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All pregnant women who are planned for elective (planned&amp; pre labor) cesarean section at 34&#xD;
        -37 weeks gestation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancies with known fetal malformation/s or chromosomal aberrations.&#xD;
&#xD;
          2. Presence of absolute contraindication for use of misoprostol.(i.e known&#xD;
             hypersensitivity to the drug)&#xD;
&#xD;
          3. Women before 34 and after 37 weeks gestation .&#xD;
&#xD;
          4. Non reassuring cardiotocogram immediately before recruitment.&#xD;
&#xD;
          5. multiple pregnancies.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Makhlouf, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>women health center,Assiut university,Assiut,Egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Makhlouf, professor</last_name>
    <phone>0882414616</phone>
    <email>amakhloufsalama@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>women health center,Assiut university</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Makhlouf, Professor</last_name>
      <phone>0882414616</phone>
      <email>amakhloufsalama@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Motaze NV, Mbuagbaw L, Young T. Prostaglandins before caesarean section for preventing neonatal respiratory distress. Cochrane Database Syst Rev. 2013 Nov 11;(11):CD010087. doi: 10.1002/14651858.CD010087.pub2.</citation>
    <PMID>24218013</PMID>
  </reference>
  <reference>
    <citation>Singh M, Patole S, Rane A, Naidoo D, Buettner P. Maternal intravaginal prostaglandin E2 gel before elective caesarean section at term to induce catecholamine surge in cord blood: randomised, placebo controlled study. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F131-5. doi: 10.1136/adc.2002.025957.</citation>
    <PMID>14977896</PMID>
  </reference>
  <reference>
    <citation>Hansen AK, Wisborg K, Uldbjerg N, Henriksen TB. Risk of respiratory morbidity in term infants delivered by elective caesarean section: cohort study. BMJ. 2008 Jan 12;336(7635):85-7. doi: 10.1136/bmj.39405.539282.BE. Epub 2007 Dec 11.</citation>
    <PMID>18077440</PMID>
  </reference>
  <reference>
    <citation>Yang JY, Fang LJ, Tsou Yau KI. Labor pain before elective cesarean section reduces neonatal respiratory distress. Zhonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi. 1997 Jan-Feb;38(1):38-43.</citation>
    <PMID>9066188</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>January 4, 2018</last_update_submitted>
  <last_update_submitted_qc>January 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Makhlouf</investigator_full_name>
    <investigator_title>Professor.Ahmed Mohammed Ahmed Makhlouf</investigator_title>
  </responsible_party>
  <keyword>Misoprostol</keyword>
  <keyword>neonatal</keyword>
  <keyword>respiratory distress</keyword>
  <keyword>cesarean section</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>Alprostadil</mesh_term>
    <mesh_term>Misoprostol</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/NCT03239327
org study id: assiut university women health
nct id: NCT03239327
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Project summary:

      Objective: To test the hypothesis that administration of vaginal Misoprostol before elective
      cesarean section will improve the neonatal respiratory outcomes in late preterm and early
      term neonates through induction of catecholamine surge.

      Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university
      hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two
      hundred and ninety two women will be randomly allocated to receive either 50 micrograms of
      Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or
      receive nothing (control group; n = 146) .

      Main outcome measure: Apgar score at 1 and 5 minutes.
Methodology: After a written informed consent obtained, women who are fitting the inclusion
      criteria will be randomly allocated using sealed, coded, opaque and sequentially numbered
      envelopes containing computer generated random numbers into either the study group or the
      control group. For the study group the enrolled women will receive 50 microgram misoprostol
      vaginally within 60 minutes before CS. For the control group mothers enrolled will receive
      nothing.

      Observation and data collection: Cardiotocographic monitoring will be undertaken after
      maternal misoprostol administration to detect any evidence of uterine hyperstimulation and
      fetal distress.

      Ritodrine IV will be used as a tocolytic agent in case of uterine tachysystole. 100 mg of
      ritodrine will be added to 500 ml of 0.5% dextrose, the solution will be administered as
      following:

      5 drops / minute in the 1st 10 minutes. 10 drops / minute in the next 10 minutes then 15
      drops / minute . The clinician should adjust the infusion rate so that the pulse rate doesn't
      exceed 120b/min and lung bases are free of crepitations.

      The surgical and anesthetic teams will be in a state of complete readiness for the ECS from
      the time of maternal misoprostol administration after enrollment. Details on maternal
      fluid-electrolyte status during ECS will be recorded as maternal fluid overload is reported
      to be associated with respiratory distress in the newborn. (SinghiS,Chookang E;1984) blood
      loss during and 1 hour after the operation will be estimated.

      Maternal data: Patient name, hospital number, age, parity, gestational age, any medical
      disorder and indication of CS.

      Neonatal observations: delivery room care details will be noted, neonatal heart rate,
      respiratory rate, and signs of respiratory distress- for example, grunting, chest wall
      retractions, nasal flaring- will be recorded hourly in the postnatal ward for eight hours and
      once only at 24 hours of age after delivery. Management of a neonate with respiratory
      distress (defined as respiratory rate at rest.60/min and/or signs of respiratory distress)
      will be left to the neonatal team. Severity of illness, provisional and final diagnosis, and
      outcome (death/discharge home/transfer to other hospital) will be recorded if any neonate
      would be admitted to the neonatal intensive care unit for respiratory distress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.
time frame: During the first 24 hours of life.
description: The number of neonates who need Neonatal Intensive Care Unit admission in each study group
arm group label: study group
arm group type: Experimental
description: For the study group the enrolled women will receive 50 microgram misoprostol vaginally 60 minutes before CS
arm group label: control group
arm group type: No Intervention
description: For the control group mothers enrolled will receive nothing.
intervention type: Drug
intervention name: Misoprostol
arm group label: study group
other name: Prostaglandin E1,Cytotec
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ahmed Makhlouf, professor
role: Principal Investigator
affiliation: women health center,Assiut university,Assiut,Egypt
last name: Ahmed Makhlouf, professor
phone: 0882414616
email: amakhloufsalama@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Motaze NV, Mbuagbaw L, Young T. Prostaglandins before caesarean section for preventing neonatal respiratory distress. Cochrane Database Syst Rev. 2013 Nov 11;(11):CD010087. doi: 10.1002/14651858.CD010087.pub2.
PMID: 24218013
citation: Singh M, Patole S, Rane A, Naidoo D, Buettner P. Maternal intravaginal prostaglandin E2 gel before elective caesarean section at term to induce catecholamine surge in cord blood: randomised, placebo controlled study. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F131-5. doi: 10.1136/adc.2002.025957.
PMID: 14977896
citation: Hansen AK, Wisborg K, Uldbjerg N, Henriksen TB. Risk of respiratory morbidity in term infants delivered by elective caesarean section: cohort study. BMJ. 2008 Jan 12;336(7635):85-7. doi: 10.1136/bmj.39405.539282.BE. Epub 2007 Dec 11.
PMID: 18077440
citation: Yang JY, Fang LJ, Tsou Yau KI. Labor pain before elective cesarean section reduces neonatal respiratory distress. Zhonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi. 1997 Jan-Feb;38(1):38-43.
PMID: 9066188
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Makhlouf
investigator title: Professor.Ahmed Mohammed Ahmed Makhlouf
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Distress Syndrome
mesh term: Alprostadil
mesh term: Misoprostol
sharing ipd: Undecided