<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/NCT04477226</url>
  </required_header>
  <id_info>
    <org_study_id>FF-2019-368</org_study_id>
    <nct_id>NCT04477226</nct_id>
  </id_info>
  <brief_title>Transvaginal Ultrasound As Predictors of Successful Induction of Labour</brief_title>
  <official_title>Pre-Induction Cervical Assessment Using Transvaginal Ultrasound Versus Bishop's Cervical Scoring in Term Pregnancies As Predictors of Successful Induction of Labour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Kebangsaan Malaysia Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Kebangsaan Malaysia Medical Centre</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 compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to&#xD;
      induction of labour in term pregnancies, and the ability to predict Caesarean delivery for&#xD;
      failure to progress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of&#xD;
      cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability&#xD;
      to predict Caesarean delivery for failure to progress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction</measure>
    <time_frame>before induction of labour</time_frame>
    <description>measurement of cervical length in cm</description>
  </primary_outcome>
  <enrollment type="Actual">294</enrollment>
  <condition>Induction of Labour</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transvaginal ultrasound scan</intervention_name>
    <description>Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who are admitted for induction of labour and fulfils the criteria will be&#xD;
        recruited from Patient Admission Centre (PAC), antenatal ward, labour room&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nulliparous or multipara&#xD;
&#xD;
          -  Singleton live pregnancy&#xD;
&#xD;
          -  Gestational age between 37 - 42 weeks&#xD;
&#xD;
          -  Cephalic presentation&#xD;
&#xD;
          -  Intact membranes&#xD;
&#xD;
          -  Reactive cardiotocograph tracing&#xD;
&#xD;
          -  Low risk pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of uterine surgery&#xD;
&#xD;
          -  Low lying placenta, placenta praevia and vaginal bleeding&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Preterm Prelabour rupture of membrane/ prelabour rupture of membranes&#xD;
&#xD;
          -  Known allergy towards prostaglandins&#xD;
&#xD;
          -  Intrauterine fetal death&#xD;
&#xD;
          -  Known fetal anomaly&#xD;
&#xD;
          -  Estimated fetal weight &gt;3.8kg by scan&#xD;
&#xD;
          -  Grandmultiparity (more than 5)&#xD;
&#xD;
          -  BMI &gt;40kg/m2&#xD;
&#xD;
          -  Diabetes and hypertension on treatment&#xD;
&#xD;
          -  Other medical illness on treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only female pregnant patient</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Kah Teik Chew</last_name>
    <role>Principal Investigator</role>
    <affiliation>UKMMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universiti Kebangsaan Malaysia Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04477226
org study id: FF-2019-368
nct id: NCT04477226
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the use of transvaginal ultrasound (TVUS) of cervix to the Bishops score prior to
      induction of labour in term pregnancies, and the ability to predict Caesarean delivery for
      failure to progress.
The aim of this prospective study is to compare the use of transvaginal ultrasound (TVUS) of
      cervix to the Bishops score prior to induction of labour in term pregnancies, and the ability
      to predict Caesarean delivery for failure to progress.
observational model: Case-Only
time perspective: Prospective
measure: To determine the optimal cutoff points for cervical length measurement as predictor of successful labour induction
time frame: before induction of labour
description: measurement of cervical length in cm
intervention type: Diagnostic Test
intervention name: Transvaginal ultrasound scan
description: Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: only female pregnant patient
minimum age: 18 Years
maximum age: 45 Years
last name: Kah Teik Chew
role: Principal Investigator
affiliation: UKMMC
facility: 
country: Malaysia
responsible party type: Sponsor
sharing ipd: No