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/NCT05986344</url>
    </required_header>
    <id_info>
      <org_study_id>Doppler IUD</org_study_id>
      <nct_id>NCT05986344</nct_id>
    </id_info>
    <brief_title>Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device</brief_title>
    <official_title>Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System</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>
        To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual&#xD;
        changes after 3 months of insertion of copper T-380 IUD and LNG-IUS&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized prospective clinical trial&#xD;
  &#xD;
        Study Population:&#xD;
  &#xD;
        The study population includes multiparous women, having normal menstrual cycles, who are&#xD;
        eligible for insertion of IUCD. Women will be recruited for enrollment when they come to the&#xD;
        family planning clinic. They will be counseled about different contraceptive options. If they&#xD;
        want to have the IUCD, they will be asked to participate in the study after been evaluated to&#xD;
        ensure fulfilling inclusion and exclusion criteria Women will be enrolled in the study after&#xD;
        giving written informed consent Group (A): ….Women will have the copper T-380 IUD (PREGNA,&#xD;
        India, imported by DKT Egypt LLC-Egypt) ® IUD.&#xD;
  &#xD;
        Group (B): …. Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD&#xD;
        .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>menstrual changes.</measure>
      <time_frame>3 months after insertion</time_frame>
      <description>Pictorial blood loss assessment chart PBAC score (a score &gt;100was equivalent to blood loss &gt;80 mL)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>uterine artery pulsatility index</measure>
      <time_frame>3 months after insertion</time_frame>
      <description>trans-vaginal ultrasound pulsed doppler</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">165</enrollment>
    <condition>Intrauterine Contraceptive Device Complication</condition>
    <arm_group>
      <arm_group_label>Copper intrauterine contraceptive device</arm_group_label>
      <description>Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Levonorgestrel Intrauterine System</arm_group_label>
      <description>Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Copper intrauterine contraceptive device</intervention_name>
      <description>copper T-380 IUD</description>
      <arm_group_label>Copper intrauterine contraceptive device</arm_group_label>
      <other_name>silverline</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>LNG-IUS</intervention_name>
      <description>Levonorgestrel Intrauterine System</description>
      <arm_group_label>Levonorgestrel Intrauterine System</arm_group_label>
      <other_name>mirena</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population includes multiparous women, having normal menstrual cycles, who are&#xD;
          eligible for insertion of IUCD. Women will be recruited for enrollment when they come to&#xD;
          the family planning clinic. They will be counseled about different contraceptive options.&#xD;
          If they want to have the IUCD, they will be asked to participate in the study after been&#xD;
          evaluated to ensure fulfilling inclusion and exclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Desire to have intrauterine contraceptive device after counseling about different&#xD;
               contraceptive options and consented to the study.&#xD;
  &#xD;
            -  Normal menstrual bleeding cycles (24-35 days).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Nulliparity.&#xD;
  &#xD;
            2. Undiagnosed uterine bleeding.&#xD;
  &#xD;
            3. Any proven ovarian, uterine or endometrial pathology such as; uterine myoma,&#xD;
               adenomyosis, endometrial polyps, ovarian cysts&#xD;
  &#xD;
            4. Contraceptive pills had not been taken during the previous 3 months and any previous&#xD;
               IUD had been removed at least 1 month earlier&#xD;
  &#xD;
            5. Hemorrhagic disorders.&#xD;
  &#xD;
            6. Acute or chronic pelvic inflammatory disease&#xD;
  &#xD;
            7. Known uterine anomalies e.g., Bicornuate/septate Uterus.&#xD;
  &#xD;
            8. Anemia (hemoglobin &lt;10 g/dl).&#xD;
  &#xD;
            9. Diagnosis of active cervical infection&#xD;
  &#xD;
           10. Dysplasia in the cervix.&#xD;
  &#xD;
           11. Patients wishing post-partum or post-abortum IUD insertion&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Beni-Suef University</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Medicine Beni-Suef University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sara A Salem, MD</last_name>
      <phone>01272842226</phone>
      <phone_ext>02</phone_ext>
      <email>sara_abdallah100@yahoo.com</email>
    </overall_contact>
    <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>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>Intrauterine Contraceptive Device</keyword>
    <keyword>Doppler</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Copper</mesh_term>
      <mesh_term>Contraceptive Agents</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/NCT05986344
  org study id: Doppler IUD
  nct id: NCT05986344
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual
        changes after 3 months of insertion of copper T-380 IUD and LNG-IUS
  A randomized prospective clinical trial
  
        Study Population:
  
        The study population includes multiparous women, having normal menstrual cycles, who are
        eligible for insertion of IUCD. Women will be recruited for enrollment when they come to the
        family planning clinic. They will be counseled about different contraceptive options. If they
        want to have the IUCD, they will be asked to participate in the study after been evaluated to
        ensure fulfilling inclusion and exclusion criteria Women will be enrolled in the study after
        giving written informed consent Group (A): ….Women will have the copper T-380 IUD (PREGNA,
        India, imported by DKT Egypt LLC-Egypt) ® IUD.
  
        Group (B): …. Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD
        .
  observational model: Cohort
  time perspective: Prospective
  measure: menstrual changes.
  time frame: 3 months after insertion
  description: Pictorial blood loss assessment chart PBAC score (a score >100was equivalent to blood loss >80 mL)
  measure: uterine artery pulsatility index
  time frame: 3 months after insertion
  description: trans-vaginal ultrasound pulsed doppler
  arm group label: Copper intrauterine contraceptive device
  description: Women will have the copper T-380 IUD (silverline, imported by DKT Egypt LLC-Egypt) ® IUD.
  arm group label: Levonorgestrel Intrauterine System
  description: Women will recieve the LNG-IUS (Mirena, Bayer HealthCare, Berlin, Germany)® IUD .
  intervention type: Device
  intervention name: Copper intrauterine contraceptive device
  description: copper T-380 IUD
  arm group label: Copper intrauterine contraceptive device
  other name: silverline
  intervention type: Device
  intervention name: LNG-IUS
  description: Levonorgestrel Intrauterine System
  arm group label: Levonorgestrel Intrauterine System
  other name: mirena
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Beni-Suef University
  role: Principal Investigator
  affiliation: Faculty of Medicine Beni-Suef University
  last name: Sara A Salem, MD
  phone: 01272842226
  phone ext: 02
  email: sara_abdallah100@yahoo.com
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Copper
  mesh term: Contraceptive Agents
  sharing ipd: Undecided