<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/NCT01685164</url>
  </required_header>
  <id_info>
    <org_study_id>1491/13/03/03/2010</org_study_id>
    <nct_id>NCT01685164</nct_id>
  </id_info>
  <brief_title>The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women</brief_title>
  <official_title>The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <brief_summary>
    <textblock>
      As intrauterine contraception is an increasingly popular form of contraception the objective&#xD;
      of our study is to examine if uterine size or posture affects the insertion or use of&#xD;
      intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device&#xD;
      (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective observational study among nulliparous women requesting intrauterine&#xD;
      contraception.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of uterine size or posture on IUD insertion.</measure>
    <time_frame>Day 1</time_frame>
    <description>The size of the uterine cavity (cm) and the flexion angle of the uterus are determined at insertion using ultrasonography. This is compared with assessment of perception of insertion pain both by the patient and the inserting doctor is evaluated as well as the easiness if insertion (by the doctor).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction and continuation rate with intrauterine contraception.</measure>
    <time_frame>3 months</time_frame>
    <description>Clinical evaluation including gynecological examination is at 3 months after insertion. Patterns of bleeding and severeness of pain are followed daily for the 90 first days after insertion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction and continuation rate with intrauterine contraception.</measure>
    <time_frame>12 months</time_frame>
    <description>A second clinical evaluation including gynecological examination is at 12 months after insertion. Patterns of bleeding and severeness of pain are followed daily for the last 90 days of the first year of use of intrauterine contraception.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">161</enrollment>
  <condition>Intrauterine Contraception</condition>
  <arm_group>
    <arm_group_label>LNG-IUS</arm_group_label>
    <description>Nulliparous women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cu-IUD</arm_group_label>
    <description>Nulliparous women</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.</intervention_name>
    <description>Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.</description>
    <arm_group_label>Cu-IUD</arm_group_label>
    <arm_group_label>LNG-IUS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of nulliparous women attending the centralized Family&#xD;
        planning center of the City of Helsinki requesting intrauterine contraception, either the&#xD;
        LNG-IUS or a Cu-IUD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - nulliparous women with no previous history of IUD use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  malformation of uterus&#xD;
&#xD;
          -  myomas&#xD;
&#xD;
          -  acute gynecological infection&#xD;
&#xD;
          -  malignant uterine or cervical tumor&#xD;
&#xD;
        In addition if requesting a Cu-IUD&#xD;
&#xD;
          -  heavy menstruations&#xD;
&#xD;
          -  iron deficiency&#xD;
&#xD;
          -  bleeding disorder&#xD;
&#xD;
          -  copper allergy or Wilson's disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Contraceptive unit of city of Helsinki</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>February 21, 2018</last_update_submitted>
  <last_update_submitted_qc>February 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Satu P. Suhonen, MD, PhD</investigator_full_name>
    <investigator_title>Physician in chief, Centralized Family Planning, City of Helsinki Health Centre</investigator_title>
  </responsible_party>
  <keyword>nulliparous</keyword>
  <keyword>IUD</keyword>
  <keyword>IUS</keyword>
  <keyword>insertion</keyword>
  <keyword>expulsion</keyword>
  <!-- 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/NCT01685164
org study id: 1491/13/03/03/2010
nct id: NCT01685164
lead sponsor: 
As intrauterine contraception is an increasingly popular form of contraception the objective
      of our study is to examine if uterine size or posture affects the insertion or use of
      intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device
      (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.
Prospective observational study among nulliparous women requesting intrauterine
      contraception.
observational model: Case-Only
time perspective: Prospective
measure: The effect of uterine size or posture on IUD insertion.
time frame: Day 1
description: The size of the uterine cavity (cm) and the flexion angle of the uterus are determined at insertion using ultrasonography. This is compared with assessment of perception of insertion pain both by the patient and the inserting doctor is evaluated as well as the easiness if insertion (by the doctor).
measure: Satisfaction and continuation rate with intrauterine contraception.
time frame: 3 months
description: Clinical evaluation including gynecological examination is at 3 months after insertion. Patterns of bleeding and severeness of pain are followed daily for the 90 first days after insertion.
measure: Satisfaction and continuation rate with intrauterine contraception.
time frame: 12 months
description: A second clinical evaluation including gynecological examination is at 12 months after insertion. Patterns of bleeding and severeness of pain are followed daily for the last 90 days of the first year of use of intrauterine contraception.
arm group label: LNG-IUS
description: Nulliparous women
arm group label: Cu-IUD
description: Nulliparous women
intervention type: Other
intervention name: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
description: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
arm group label: Cu-IUD
arm group label: LNG-IUS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Satu P. Suhonen, MD, PhD
investigator title: Physician in chief, Centralized Family Planning, City of Helsinki Health Centre