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UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB) (UAMSPB)

Primary Purpose

Preterm Labor

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
measurement of uterocervical angle
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Preterm Labor focused on measuring uterocervical angle, preterm labor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients who did not have complaints between December 2017 and August 2018, who went to polyclinic because of routine control
  2. Patients who had a pregnancy between 16-24 weeks
  3. Patients with singleton pregnancy
  4. Patients with a cervical length of 25 mm or more

Exclusion Criteria:

  1. Patients with preterm labor history (under 37 weeks) in previous pregnancy
  2. Patients with premature rupture of membranes in current pregnancy
  3. Patients with past uterine cervical surgery (conization, LEEP) as a cause of premature birth
  4. Patients with preterm birth
  5. Placenta anomalies present pregnancy
  6. Patient with retrovert uterus, uterine fibroid of lower segment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    voluson 8

    Arm Description

    Outcomes

    Primary Outcome Measures

    The measurement of patients after they give birth
    Images were re-measured for uterocervical angle between the lower uterine segment and the cervical canal. Primary outcome was prediction of <37 weeks by uterocervikal angle.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2018
    Last Updated
    August 8, 2018
    Sponsor
    Istanbul Medeniyet University
    Collaborators
    Meryem Dilara Yetimoğlu, İdris Yetimoğlu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03623685
    Brief Title
    UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)
    Acronym
    UAMSPB
    Official Title
    RANDOMİZED , PROSPEKTİVE COHORT STUDY FOR UTEROCERVİCAL ANGLE MEASUREMENT BY ULTRASOUND FOR PREDİCTİNG SPONTANEOUS PRETERM BİRTH
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 10, 2018 (Anticipated)
    Primary Completion Date
    August 10, 2019 (Anticipated)
    Study Completion Date
    December 10, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medeniyet University
    Collaborators
    Meryem Dilara Yetimoğlu, İdris Yetimoğlu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    İn this study Study; Between August 2018 and August 2019, the Ministry of Health, Medeniyet University, Göztepe Training and Research Hospital, Gynecology and Obstetrics Clinic Will be Included for Routine Control Purposes, Single Pregnancies Between 16-24 Weeks and no Known Risk Factors for Preterm Delivery . Each Participant Will be Given Written and Verbal Information About the Work and Will be Informed. Uterocervical Angle Measurement; Dorsolithotomy, Using a Sterilized Vaginal Ultrasonic Probe. It Will be Seen That the Distance Between the Internal Cervical os and the External Cervical os is Inclusive of the Cervical Isthmus That Can be Seen With the Anterior Uterine Wall. The First Line Will be Drawn Between the Internal Cervical os and the External Cervical os. The Second Line Will be Drawn as Passing Through the Internal Cervical Ostia, Parallel to the Anterior Uterine Wall. The Angle Between the Two Lines on the Internal Cervical Vertebra Will be Measured. Patients Will be Followed up Until the End of the 37th Gestational Week. The Gestation Week They Are Giving Birth Will be Recorded. Patients Were Then Classified as Before and After 37 Gestational Weeks and Uterocervical Angle Measurements Between 16-24 Gestational Weeks Were Compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Labor
    Keywords
    uterocervical angle, preterm labor

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    voluson 8
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    measurement of uterocervical angle
    Intervention Description
    We will measure between internal cervikal os and external cervical os. After we will draw a line between anterior uterine wall and internal cervical os. Then we will measure angle between two lines
    Primary Outcome Measure Information:
    Title
    The measurement of patients after they give birth
    Description
    Images were re-measured for uterocervical angle between the lower uterine segment and the cervical canal. Primary outcome was prediction of <37 weeks by uterocervikal angle.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who did not have complaints between December 2017 and August 2018, who went to polyclinic because of routine control Patients who had a pregnancy between 16-24 weeks Patients with singleton pregnancy Patients with a cervical length of 25 mm or more Exclusion Criteria: Patients with preterm labor history (under 37 weeks) in previous pregnancy Patients with premature rupture of membranes in current pregnancy Patients with past uterine cervical surgery (conization, LEEP) as a cause of premature birth Patients with preterm birth Placenta anomalies present pregnancy Patient with retrovert uterus, uterine fibroid of lower segment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    meryem dilara yetimoğlu
    Phone
    +905422274427
    Email
    saylardilara@windowslive.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    özkan özdamar
    Organizational Affiliation
    Istanbul Medeniyet University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27018466
    Citation
    Dziadosz M, Bennett TA, Dolin C, West Honart A, Pham A, Lee SS, Pivo S, Roman AS. Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth. Am J Obstet Gynecol. 2016 Sep;215(3):376.e1-7. doi: 10.1016/j.ajog.2016.03.033. Epub 2016 Mar 24.
    Results Reference
    background

    Learn more about this trial

    UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)

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