<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/NCT03038607</url>
  </required_header>
  <id_info>
    <org_study_id>ASP</org_study_id>
    <nct_id>NCT03038607</nct_id>
  </id_info>
  <brief_title>Aspirin in Asymmetrically Intrauterine Growth</brief_title>
  <official_title>Effect of Low-dose Aspirin on Fetal Weight of Idiopathic Asymmetrically Intrauterine Growth Restricted Fetuses With Abnormal Umbilical Doppler Indices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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>
      Intrauterine growth restriction refers to a fetus that has failed to get a specific measures&#xD;
      by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal&#xD;
      sized head with smaller abdomen.It is important to recognize the growth restricted fetuses,&#xD;
      because these fetuses may have fetal or neonatal complications.&#xD;
&#xD;
      When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The&#xD;
      role of low-dose aspirin therapy in management of intrauterine growth restriction is&#xD;
      controversial. It has been used, in many studies, in prevention of intrauterine growth&#xD;
      restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid&#xD;
      syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated fetal weight</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Doppler blood flow indices in umbilical artery</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Intrauterine Growth Restriction Asymmetrical</condition>
  <arm_group>
    <arm_group_label>Aspirin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>This group were subjected to aspirin 75 mg once daily for 6 weeks.</description>
    <arm_group_label>Aspirin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The pregnant women&#xD;
&#xD;
          -  28-30 weeks&#xD;
&#xD;
          -  Idiopathic asymmetrically intrauterine growth restriction&#xD;
&#xD;
          -  Middle aged women (20-35 years)&#xD;
&#xD;
          -  Women with abnormal umbilical artery Doppler flow indices ( &gt; +2 standard deviation&#xD;
             above mean for gestational age)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women less than 20 and more than 35 years&#xD;
&#xD;
          -  hypertensive or diabetic women&#xD;
&#xD;
          -  any type of smoking&#xD;
&#xD;
          -  multiple pregnancies&#xD;
&#xD;
          -  amniotic fluid index &lt;5 cm&#xD;
&#xD;
          -  premature pre-labor rupture of membranes&#xD;
&#xD;
          -  abnormal placenta&#xD;
&#xD;
          -  any fetal congenital malformations.&#xD;
&#xD;
          -  women had absent diastolic flow or reversed flow in umbilical artery at the time of&#xD;
             recruitment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 29, 2017</last_update_submitted>
  <last_update_submitted_qc>January 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03038607
org study id: ASP
nct id: NCT03038607
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intrauterine growth restriction refers to a fetus that has failed to get a specific measures
      by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal
      sized head with smaller abdomen.It is important to recognize the growth restricted fetuses,
      because these fetuses may have fetal or neonatal complications.

      When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The
      role of low-dose aspirin therapy in management of intrauterine growth restriction is
      controversial. It has been used, in many studies, in prevention of intrauterine growth
      restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid
      syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Estimated fetal weight
time frame: 6 weeks
measure: Birth weight
time frame: 6 weeks
measure: Changes in Doppler blood flow indices in umbilical artery
time frame: 6 weeks
arm group label: Aspirin group
arm group type: Active Comparator
arm group label: No intervention
arm group type: No Intervention
intervention type: Drug
intervention name: Aspirin
description: This group were subjected to aspirin 75 mg once daily for 6 weeks.
arm group label: Aspirin group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Dr
mesh term: Fetal Growth Retardation
mesh term: Aspirin
sharing ipd: Yes