<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/NCT03828695</url>
  </required_header>
  <id_info>
    <org_study_id>10988</org_study_id>
    <nct_id>NCT03828695</nct_id>
  </id_info>
  <brief_title>Uterocervical Angle in Idiopathic Polyhydramnios</brief_title>
  <official_title>Efficacy and Efficiency of Uterocervical Angle for Prediction of Preterm Labor in Patients With Idiopathic Polyhydramnios: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nefise Nazlı YENIGUL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanliurfa Mehmet Akif Inan Education and Research Hospital</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>
      To evaluate the performance of uterocervical angle (UCA) in the prediction of preterm labor&#xD;
      in isolated polyhydramnios&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>prediction of preterm birth by uterocervical angle in patients with idiopathic polyhydramnios.</measure>
    <time_frame>6 month</time_frame>
    <description>During the study period, women were enrolled and uterocervical angle were measured in the first evaluations of polyhydramnios patients in policlinics. Routine pregnancy follow-up was done by our team and weeks of delivery and maternal-fetal outcomes were noted.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Preterm Labor</condition>
  <arm_group>
    <arm_group_label>uterocervical angle</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>uterocervical angle is the angle between lower segment of uterus and cervix</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>uterocervical angle</intervention_name>
    <description>uterocervical angle is the angle between lower segment of uterus and cervix</description>
    <arm_group_label>uterocervical angle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  isolated polyhydramnios pregnancies&#xD;
&#xD;
          -  no previous systemic illnesses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  abnormal Pap smear&#xD;
&#xD;
          -  previous cesarean section&#xD;
&#xD;
          -  history of dilatation and curettage (D&amp;C)&#xD;
&#xD;
          -  history of loop electrosurgical excision procedure (LEEP) and cervical conization&#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>Nefise N YENIGUL</name>
      <address>
        <city>Sanlıurfa</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>July 21, 2019</last_update_submitted>
  <last_update_submitted_qc>July 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sanliurfa Mehmet Akif Inan Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Nefise Nazlı YENIGUL</investigator_full_name>
    <investigator_title>Ph.D. Assistant Professor Department of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Polyhydramnios</mesh_term>
  </condition_browse>
  <!-- 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/NCT03828695
org study id: 10988
nct id: NCT03828695
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the performance of uterocervical angle (UCA) in the prediction of preterm labor
      in isolated polyhydramnios
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: prediction of preterm birth by uterocervical angle in patients with idiopathic polyhydramnios.
time frame: 6 month
description: During the study period, women were enrolled and uterocervical angle were measured in the first evaluations of polyhydramnios patients in policlinics. Routine pregnancy follow-up was done by our team and weeks of delivery and maternal-fetal outcomes were noted.
arm group label: uterocervical angle
arm group type: Other
description: uterocervical angle is the angle between lower segment of uterus and cervix
intervention type: Other
intervention name: uterocervical angle
description: uterocervical angle is the angle between lower segment of uterus and cervix
arm group label: uterocervical angle
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Sanliurfa Mehmet Akif Inan Education and Research Hospital
investigator full name: Nefise Nazlı YENIGUL
investigator title: Ph.D. Assistant Professor Department of Obstetrics and Gynecology
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
mesh term: Polyhydramnios