<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/NCT04425577</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001082</org_study_id>
    <nct_id>NCT04425577</nct_id>
  </id_info>
  <brief_title>Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length</brief_title>
  <official_title>Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To determine if uterine cavity length on transabdominal pelvic ultrasound corresponds to&#xD;
      uterine cavity length at time of IUD insertion. If transabdominal pelvic ultrasound is&#xD;
      validated as a tool for measuring uterine cavity length, it can be used to guide physicians&#xD;
      and subsequently patients in IUD insertion planning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Levonogesterel (progestin only) IUDs have been used in the adult population for decades and&#xD;
      due to their safety and efficacy are now successfully used in the nulliparous and adolescent&#xD;
      population for menstrual regulation, dysmenorrhea, and contraception. IUDs have the highest&#xD;
      continuation rate among teens of all forms of contraception at 12 months (86%). IUDs reduce&#xD;
      menstrual flow by 90% 12 months post insertion, decrease menstrual cramp severity, and have&#xD;
      greater than 99% effective contraception. All of this make IUDs an attractive option for our&#xD;
      teens and their caregivers&#xD;
&#xD;
      At time of IUD insertion, a uterine sound is used to measure the cavity length. A sound is a&#xD;
      rigid instrument that is placed inside the uterus to directly measure the uterine cavity&#xD;
      length and is the standard first step prior to IUD insertion. The cavity length will&#xD;
      ultimately determine the type and size of IUD that can be placed. Two manufacturers, Mirena ®&#xD;
      and Sklya ® are currently being used in clinical practice. Mirena requires uterine cavity&#xD;
      length between 6-10 cm and Sklya requires 4-8 cm length. To determine this length requires a&#xD;
      pelvic exam and the use of uterine sound, however, approximately 50% of our patient&#xD;
      population is unable to tolerate pelvic exams due to a variety of factors, such as&#xD;
      developmental disabilities or pain. Thus, this requires patients to go under general&#xD;
      anesthesia to have their IUD placed. The goal of this study is to determine if the actual&#xD;
      uterine cavity length corresponds to the transabdominal measurement of the uterine cavity&#xD;
      length.&#xD;
&#xD;
      Uterine size is largely under the influence of estrogen and as an adolescent progresses&#xD;
      through puberty the dimensions of the uterus change. Given that a large portion of families&#xD;
      seeking menstrual suppression &amp; regulation present relatively close to menarche (mean age of&#xD;
      12.3 years old) there is a precedent for an institutional standard for pre-IUD insertion&#xD;
      transabdominal ultrasound to ensure the uterus is of sufficient caliber&#xD;
&#xD;
      Prior research has focused on those undergoing intra-operative placement of a Mirena IUD. In&#xD;
      one retrospective chart review of 56 adolescent patients with developmental disabilities,&#xD;
      there was a 3.7% (2/56) failure rate of intra-operative IUD placement (abandoned IUD&#xD;
      insertion in the operating room after anesthesia administration). One failure was due to the&#xD;
      pelvimetry of the child and the other was due to a uterine cavity length of 4cm which was&#xD;
      deemed insufficient for the Mirena IUD. In addition, two other patients had a uterus sound to&#xD;
      less than 6 (5cm and 5.5cm) and Mirena was inserted anyways (Skyla was not available). About&#xD;
      half of these patients had a pre-operative transabdominal US of the pelvis and the total&#xD;
      uterine length was measured with an average length of 8.3cm. All uterine cavities were&#xD;
      measured intra-op with an average length of 7.4cm.&#xD;
&#xD;
      Ultimately, all prior research has measured the length of the full uterus (uterine fundus,&#xD;
      body of the uterus, and cervix) which is not representative of the measurement in question&#xD;
      for IUD placement, the uterine cavity length. We propose a prospective cohort pilot study to&#xD;
      compare transabdominal ultrasound measurements with uterine sound measurements to determine&#xD;
      uterine cavity length. If these measures correlate, transabdominal US could be a validated&#xD;
      pre-insertion tool for the physician and patient to avoid unnecessary anesthetic events and&#xD;
      have appropriate IUDs available for insertion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2020</start_date>
  <completion_date type="Actual">February 1, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients who are clinically undergoing intrauterine device (IUD) placement will be consecutively studied</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantify Temporal Relationship between Transabdominal Ultrasound and Uterine Sound</measure>
    <time_frame>Within 60 days of enrollment</time_frame>
    <description>To determine if uterine cavity length on ultrasound corresponds to uterine cavity length at time of IUD insertion</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Dysmenorrhea</condition>
  <condition>Heavy Menstrual Bleeding</condition>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Transabdominal Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients enrolled will undergo a transabdominal ultrasound at a specified time point as outlined in the protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transabdominal Ultrasound</intervention_name>
    <description>Transabdominal Ultrasound</description>
    <arm_group_label>Transabdominal Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females age 12 - 22 years old at time of transabdominal ultrasound whom are being&#xD;
             considered for IUD placement as part of routine clinical care will be approached for&#xD;
             inclusion in the study.&#xD;
&#xD;
          -  IUD inserted between 12/1/19 and 12/1/20&#xD;
&#xD;
          -  Received a transabdominal US of the uterus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  US never performed&#xD;
&#xD;
          -  Mullerian anomaly&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This is for intrauterine device placement so all participants must have a uterus.</gender_description>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashli Lawson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Hospital Kansas City</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julie Strickland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Hospital Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Usinger KM, Gola SB, Weis M, Smaldone A. Intrauterine Contraception Continuation in Adolescents and Young Women: A Systematic Review. J Pediatr Adolesc Gynecol. 2016 Dec;29(6):659-667. doi: 10.1016/j.jpag.2016.06.007. Epub 2016 Jul 4.</citation>
    <PMID>27386754</PMID>
  </reference>
  <reference>
    <citation>Savasi I, Jayasinghe K, Moore P, Jayasinghe Y, Grover SR. Complication rates associated with levonorgestrel intrauterine system use in adolescents with developmental disabilities. J Pediatr Adolesc Gynecol. 2014 Feb;27(1):25-8. doi: 10.1016/j.jpag.2013.08.010. Epub 2013 Dec 4.</citation>
    <PMID>24315712</PMID>
  </reference>
  <reference>
    <citation>Dizon CD, Allen LM, Ornstein MP. Menstrual and contraceptive issues among young women with developmental delay: a retrospective review of cases at the Hospital for Sick Children, Toronto. J Pediatr Adolesc Gynecol. 2005 Jun;18(3):157-62. doi: 10.1016/j.jpag.2005.03.002.</citation>
    <PMID>15970247</PMID>
  </reference>
  <reference>
    <citation>Lacy J. Clinic opinions regarding IUCD use in adolescents. J Pediatr Adolesc Gynecol. 2006 Aug;19(4):301-3. doi: 10.1016/j.jpag.2006.05.013. No abstract available.</citation>
    <PMID>16873036</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Ashli Lawson</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menorrhagia</mesh_term>
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04425577
org study id: STUDY00001082
nct id: NCT04425577
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To determine if uterine cavity length on transabdominal pelvic ultrasound corresponds to
      uterine cavity length at time of IUD insertion. If transabdominal pelvic ultrasound is
      validated as a tool for measuring uterine cavity length, it can be used to guide physicians
      and subsequently patients in IUD insertion planning.
Levonogesterel (progestin only) IUDs have been used in the adult population for decades and
      due to their safety and efficacy are now successfully used in the nulliparous and adolescent
      population for menstrual regulation, dysmenorrhea, and contraception. IUDs have the highest
      continuation rate among teens of all forms of contraception at 12 months (86%). IUDs reduce
      menstrual flow by 90% 12 months post insertion, decrease menstrual cramp severity, and have
      greater than 99% effective contraception. All of this make IUDs an attractive option for our
      teens and their caregivers

      At time of IUD insertion, a uterine sound is used to measure the cavity length. A sound is a
      rigid instrument that is placed inside the uterus to directly measure the uterine cavity
      length and is the standard first step prior to IUD insertion. The cavity length will
      ultimately determine the type and size of IUD that can be placed. Two manufacturers, Mirena ®
      and Sklya ® are currently being used in clinical practice. Mirena requires uterine cavity
      length between 6-10 cm and Sklya requires 4-8 cm length. To determine this length requires a
      pelvic exam and the use of uterine sound, however, approximately 50% of our patient
      population is unable to tolerate pelvic exams due to a variety of factors, such as
      developmental disabilities or pain. Thus, this requires patients to go under general
      anesthesia to have their IUD placed. The goal of this study is to determine if the actual
      uterine cavity length corresponds to the transabdominal measurement of the uterine cavity
      length.

      Uterine size is largely under the influence of estrogen and as an adolescent progresses
      through puberty the dimensions of the uterus change. Given that a large portion of families
      seeking menstrual suppression & regulation present relatively close to menarche (mean age of
      12.3 years old) there is a precedent for an institutional standard for pre-IUD insertion
      transabdominal ultrasound to ensure the uterus is of sufficient caliber

      Prior research has focused on those undergoing intra-operative placement of a Mirena IUD. In
      one retrospective chart review of 56 adolescent patients with developmental disabilities,
      there was a 3.7% (2/56) failure rate of intra-operative IUD placement (abandoned IUD
      insertion in the operating room after anesthesia administration). One failure was due to the
      pelvimetry of the child and the other was due to a uterine cavity length of 4cm which was
      deemed insufficient for the Mirena IUD. In addition, two other patients had a uterus sound to
      less than 6 (5cm and 5.5cm) and Mirena was inserted anyways (Skyla was not available). About
      half of these patients had a pre-operative transabdominal US of the pelvis and the total
      uterine length was measured with an average length of 8.3cm. All uterine cavities were
      measured intra-op with an average length of 7.4cm.

      Ultimately, all prior research has measured the length of the full uterus (uterine fundus,
      body of the uterus, and cervix) which is not representative of the measurement in question
      for IUD placement, the uterine cavity length. We propose a prospective cohort pilot study to
      compare transabdominal ultrasound measurements with uterine sound measurements to determine
      uterine cavity length. If these measures correlate, transabdominal US could be a validated
      pre-insertion tool for the physician and patient to avoid unnecessary anesthetic events and
      have appropriate IUDs available for insertion.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients who are clinically undergoing intrauterine device (IUD) placement will be consecutively studied
primary purpose: Diagnostic
masking: None (Open Label)
measure: Quantify Temporal Relationship between Transabdominal Ultrasound and Uterine Sound
time frame: Within 60 days of enrollment
description: To determine if uterine cavity length on ultrasound corresponds to uterine cavity length at time of IUD insertion
arm group label: Transabdominal Ultrasound
arm group type: Other
description: All patients enrolled will undergo a transabdominal ultrasound at a specified time point as outlined in the protocol.
intervention type: Diagnostic Test
intervention name: Transabdominal Ultrasound
description: Transabdominal Ultrasound
arm group label: Transabdominal Ultrasound
criteria: 
gender: Female
gender based: Yes
gender description: This is for intrauterine device placement so all participants must have a uterus.
minimum age: 12 Years
maximum age: 22 Years
healthy volunteers: No
last name: Ashli Lawson, MD
role: Principal Investigator
affiliation: Children's Mercy Hospital Kansas City
last name: Julie Strickland, MD
role: Principal Investigator
affiliation: Children's Mercy Hospital Kansas City
facility: 
country: United States
citation: Usinger KM, Gola SB, Weis M, Smaldone A. Intrauterine Contraception Continuation in Adolescents and Young Women: A Systematic Review. J Pediatr Adolesc Gynecol. 2016 Dec;29(6):659-667. doi: 10.1016/j.jpag.2016.06.007. Epub 2016 Jul 4.
PMID: 27386754
citation: Savasi I, Jayasinghe K, Moore P, Jayasinghe Y, Grover SR. Complication rates associated with levonorgestrel intrauterine system use in adolescents with developmental disabilities. J Pediatr Adolesc Gynecol. 2014 Feb;27(1):25-8. doi: 10.1016/j.jpag.2013.08.010. Epub 2013 Dec 4.
PMID: 24315712
citation: Dizon CD, Allen LM, Ornstein MP. Menstrual and contraceptive issues among young women with developmental delay: a retrospective review of cases at the Hospital for Sick Children, Toronto. J Pediatr Adolesc Gynecol. 2005 Jun;18(3):157-62. doi: 10.1016/j.jpag.2005.03.002.
PMID: 15970247
citation: Lacy J. Clinic opinions regarding IUCD use in adolescents. J Pediatr Adolesc Gynecol. 2006 Aug;19(4):301-3. doi: 10.1016/j.jpag.2006.05.013. No abstract available.
PMID: 16873036
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Ashli Lawson
investigator title: Physician
mesh term: Menorrhagia
mesh term: Dysmenorrhea
sharing ipd: No