xml: <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/NCT05971654</url>
    </required_header>
    <id_info>
      <org_study_id>Azithromycin preterm</org_study_id>
      <nct_id>NCT05971654</nct_id>
    </id_info>
    <brief_title>Effect Of Azithromycin in Women at Risk of Preterm Labour</brief_title>
    <official_title>Effect Of Azithromycin On Pregnancy Prolongation In Women at Risk of Preterm Labour</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef 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>
        The aim of this study is to evaluate the benefit of the addition of azithromycin to standard&#xD;
        treatments to prolong pregnancy in women having intact membranes and is at risk of or in&#xD;
        preterm labour.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Design:&#xD;
  &#xD;
        Comparative controlled study.&#xD;
  &#xD;
        Study site :&#xD;
  &#xD;
        The study will be conducted at the department of Obstetrics and Gynecology at Beni-Suef&#xD;
        University Hospital.&#xD;
  &#xD;
        Study period:&#xD;
  &#xD;
        The study will be conducted from 15th September 2022 till reaching the target number.&#xD;
  &#xD;
        Study Population The control group will include pregnant women, having intact membranes and&#xD;
        are at risk of or in preterm labour, administrating the standard treatments for prolongation&#xD;
        of pregnancy.&#xD;
  &#xD;
        The test group will involve pregnant women, having intact membranes and are at risk of or in&#xD;
        preterm labour, administrating the standard treatments for prolongation of pregnancy plus&#xD;
        prophylactic azithromycin.:500 mg PO once for 5 days every month.&#xD;
  &#xD;
        Sample size:&#xD;
  &#xD;
        The sample size was determined using G*Power Version 3.1.9.2 [computer software] (Franz Faul,&#xD;
        Kiel, Germany),Power analysis for a chi-square test was conducted in G-POWER to determine a&#xD;
        sufficient sample size using an alpha error of probability of 0.05, power of 0.95, a medium&#xD;
        effect size (w = 0.3) and 1 degree of freedom. Based on the aforementioned assumptions, the&#xD;
        desired sample size is 145. By calculating 25% drop out, so the least total sample size in&#xD;
        both groups will be 200 patients (95 patients in each group).&#xD;
  &#xD;
        Each patient will be subjected to:&#xD;
  &#xD;
        Thorough history taking and examination. Investigations: Complete blood picture (CBC),&#xD;
        bleeding profile , kidney function tests and liver function tests will be done.&#xD;
  &#xD;
        Ultrasound: 2D Ultrasound assessing :&#xD;
  &#xD;
        It will be carried out in Gynecology and Obstetrics department in Beni-Suef University&#xD;
        Hospital, ultrasonography criteria: Ultrasound biometry of the fetus is now the gold standard&#xD;
        for assessing fetal growth. The measurements most commonly used are the biparietal diameter,&#xD;
        head circumference, abdominal circumference and femur length&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Gestational age at time of delivery</measure>
      <time_frame>9 months</time_frame>
      <description>measured in week's days'number</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Preterm Labor</condition>
    <arm_group>
      <arm_group_label>Azithromycin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>azithromycin.:500 mg PO once for 5 days every month</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>pregnant woman at risk of preterm delivery</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>azithromycin</intervention_name>
      <description>azithromycin.:500 mg PO once for 5 days every month</description>
      <arm_group_label>Azithromycin</arm_group_label>
      <other_name>zisrocin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  24 &lt; Pregnancy &lt;37 weeks of gestation.&#xD;
  &#xD;
            -  Threat or history of preterm labour.&#xD;
  &#xD;
            -  Preterm labour itself (Non established)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  antibiotics use within 14 days (except for pericerclage prophylaxis, or streptococcus&#xD;
               B prophylaxis);&#xD;
  &#xD;
            -  PPROM; and fetal extraction required &lt;37 weeks.&#xD;
  &#xD;
            -  Current or past history of medical diseases (Diabetes Milletus, Hypertension, Systemic&#xD;
               Lupus Erythematosus, Cardiac diseases, etc ).&#xD;
  &#xD;
            -  Adverse perinatal outcome due to abdominal trauma.&#xD;
  &#xD;
            -  Structural fetal anomalies detected during anomaly scan.&#xD;
  &#xD;
            -  Allergy to Azithromycin.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>preterm delivery</keyword>
    <keyword>Azithromycin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premature Birth</mesh_term>
      <mesh_term>Obstetric Labor, Premature</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Azithromycin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971654
  org study id: Azithromycin preterm
  nct id: NCT05971654
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the benefit of the addition of azithromycin to standard
        treatments to prolong pregnancy in women having intact membranes and is at risk of or in
        preterm labour.
  Study Design:
  
        Comparative controlled study.
  
        Study site :
  
        The study will be conducted at the department of Obstetrics and Gynecology at Beni-Suef
        University Hospital.
  
        Study period:
  
        The study will be conducted from 15th September 2022 till reaching the target number.
  
        Study Population The control group will include pregnant women, having intact membranes and
        are at risk of or in preterm labour, administrating the standard treatments for prolongation
        of pregnancy.
  
        The test group will involve pregnant women, having intact membranes and are at risk of or in
        preterm labour, administrating the standard treatments for prolongation of pregnancy plus
        prophylactic azithromycin.:500 mg PO once for 5 days every month.
  
        Sample size:
  
        The sample size was determined using G*Power Version 3.1.9.2 [computer software] (Franz Faul,
        Kiel, Germany),Power analysis for a chi-square test was conducted in G-POWER to determine a
        sufficient sample size using an alpha error of probability of 0.05, power of 0.95, a medium
        effect size (w = 0.3) and 1 degree of freedom. Based on the aforementioned assumptions, the
        desired sample size is 145. By calculating 25% drop out, so the least total sample size in
        both groups will be 200 patients (95 patients in each group).
  
        Each patient will be subjected to:
  
        Thorough history taking and examination. Investigations: Complete blood picture (CBC),
        bleeding profile , kidney function tests and liver function tests will be done.
  
        Ultrasound: 2D Ultrasound assessing :
  
        It will be carried out in Gynecology and Obstetrics department in Beni-Suef University
        Hospital, ultrasonography criteria: Ultrasound biometry of the fetus is now the gold standard
        for assessing fetal growth. The measurements most commonly used are the biparietal diameter,
        head circumference, abdominal circumference and femur length
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Gestational age at time of delivery
  time frame: 9 months
  description: measured in week's days'number
  arm group label: Azithromycin
  arm group type: Experimental
  description: azithromycin.:500 mg PO once for 5 days every month
  arm group label: control
  arm group type: No Intervention
  description: pregnant woman at risk of preterm delivery
  intervention type: Drug
  intervention name: azithromycin
  description: azithromycin.:500 mg PO once for 5 days every month
  arm group label: Azithromycin
  other name: zisrocin
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Premature Birth
  mesh term: Obstetric Labor, Premature
  mesh term: Azithromycin
  sharing ipd: Undecided