<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/NCT04455880</url>
  </required_header>
  <id_info>
    <org_study_id>49/2019</org_study_id>
    <nct_id>NCT04455880</nct_id>
  </id_info>
  <brief_title>Shear Wave Elastography in Gestational Diabetes Mellitus</brief_title>
  <official_title>The Comparison of Placental Elastographic Values, Fetal and Neonatal Outcomes in Pregnant Women With Gestational Diabetes and Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gulsum Uysal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adana Numune Training and Research Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our aim was to investigate and compare placental elasticity by using Shear wave elastography&#xD;
      (SWE) in patients with gestational diabetes mellitus (GDM) with and without insulin to&#xD;
      non-diabetic controls.&#xD;
&#xD;
      This prospective study included 319 pregnant patients. Three groups were created as follows:&#xD;
      Group 1 (n= 79, GDM with insulin therapy), Group 2 (n=90, GDM with only diet) and Group 3 (n=&#xD;
      150, healthy controls) All patients were above 36 gestational weeks with anterior placenta.&#xD;
      Totally six measurements including the central and peripheral parts (right, left) of the&#xD;
      placenta both from maternal and fetal sites were obtained with SWE. Demographic, obstetrics,&#xD;
      fetal and perinatal features were also compared. Receiver operating characteristic analysis&#xD;
      was plotted and cut-off of elastographic velocity values were noted&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study included singleton pregnant women aged between 18-45 years who applied&#xD;
      for third trimester prenatal examination (36 gestational weeks and above) between May 2019&#xD;
      and December 2019 at Women and Children Disease Training and Research Hospital, Istanbul,&#xD;
      Turkey. Ethical documents including Declaration of Helsinki were approved by local&#xD;
      institutional review board (Approval number:49/2019) and a written informed consent was&#xD;
      obtained from all patients. The study participants were divided into three groups according&#xD;
      to treatments. While Group 1 consisted of patients with GDM using insulin therapy (GDM A2),&#xD;
      patients with GDM treated with only diet (without any medical therapy) created Group 2 (GDM&#xD;
      A1). Group 3 included healthy controls. Insulin therapy was initiated when target cut-off&#xD;
      values were exceeded according to Carpenter and Coustan criteria. Patients with anterior&#xD;
      placenta were included in the study because the effectiveness of the method decreased.&#xD;
      Gestational age was recorded regarding last menstrual period and was checked in all&#xD;
      participants by using a first trimester ultrasound report. All GDM patients were followed up&#xD;
      in perinatology clinic and timing of delivery was organized individually basically on&#xD;
      obstetrical indications. Ultrasonographic evaluation and SWE method were performed by single&#xD;
      perinatologist Elastographic examinations were performed by physicians using Samsung HS70A&#xD;
      ultrasound system with a Samsung CA1-7A convex transducer and S-Shear wave technique. During&#xD;
      the examination, patients were lying in supine position, breathing levels kept steady to&#xD;
      prevent noise and artifacts and minimum pressure were applied on the transducer to eliminate&#xD;
      misleading tissue compression. A region of interest (ROI) box of 10 × 10 mm was positioned on&#xD;
      placenta and six measurements were obtained from central and peripheral zones of placenta&#xD;
      while avoiding vascular structures. Considering the disc-like structure of the placenta&#xD;
      measurement areas were divided into six regions as follows: maternal right, maternal central,&#xD;
      maternal left, fetal right, fetal central and fetal left. All measurements taken from&#xD;
      different zones were recorded individually along with the mean value generated using IQR&#xD;
      method. Through this approach, datasets were established not just for the auto-calculated&#xD;
      mean value but also zone specific values for further analysis. All measurements were obtained&#xD;
      in both kilopascal (kPa) and m/s formats.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group 1 (n= 79, GDM with insulin therapy), Group 2 (n=90, GDM with only diet), Group 3 (n= 150, healthy controls) All patients were above 36 gestational weeks with anterior placenta.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shear wave elastography in gestational diabetes mellitus</measure>
    <time_frame>9 months</time_frame>
    <description>To investigate and compare placental elasticity by using Shear wave elastography (SWE) in patients with gestational diabetes mellitus (GDM) with and without insulin to non-diabetic controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prediction and differentiation of GDM and prognosis with Shear wave elastography velocity cut-offs</measure>
    <time_frame>9 months</time_frame>
    <description>Cut off values of velocities will be estimated to predict GDM</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>GDM with insulin therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GDM treated with only diet (without any medical therapy)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-diabetic Controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Singleton non diabetic healthy pregnancies above 36 gestational weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity</intervention_name>
    <description>SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity. The stiffer the tissue, the higher shear wave velocity is measured. Elastographic examinations were performed by physicians using Samsung HS70A ultrasound system with a Samsung CA1-7A convex transducer and S-Shear wave technique. During the examination, patients were lying in supine position, breathing levels kept steady to prevent noise and artifacts and minimum pressure were applied on the transducer to eliminate misleading tissue compression. A region of interest (ROI) box of 10 × 10 mm was positioned on placenta and six measurements were obtained from central and peripheral zones of placenta while avoiding vascular structures</description>
    <arm_group_label>GDM treated with only diet (without any medical therapy)</arm_group_label>
    <arm_group_label>GDM with insulin therapy</arm_group_label>
    <arm_group_label>Non-diabetic Controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnant women who applied for third trimester prenatal examination&#xD;
&#xD;
          -  36 gestational weeks and above with anterior placenta&#xD;
&#xD;
          -  Diagnosed Gestational Diabetes Mellitus with 100 gr oral glucose tolerance test&#xD;
&#xD;
          -  Using insulin therapy or diet without any anti-diabetic medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple gestations,&#xD;
&#xD;
          -  pregnancies with fetal anomalies,&#xD;
&#xD;
          -  morbidly adherent placenta and uterine malformations&#xD;
&#xD;
          -  patients with systemic autoimmune diseases,&#xD;
&#xD;
          -  patients with high blood pressure,&#xD;
&#xD;
          -  patients with smoking history&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Singleton 36 weeks of gestation with anterior placenta</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hicran Acar Sirinoglu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zeynep Kamil Women and Children Disease Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zeynep Kamil Women and Children Disease Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Üsküdar</state>
        <zip>34668</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Adana Numune Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gulsum Uysal</investigator_full_name>
    <investigator_title>Associate Professor in Obstetrics and Gynecology Department</investigator_title>
  </responsible_party>
  <keyword>Shear wave elastography</keyword>
  <keyword>gestational diabetes mellitus</keyword>
  <keyword>placental stiffness</keyword>
  <keyword>high risk pregnancy</keyword>
  <keyword>placenta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</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/NCT04455880
org study id: 49/2019
nct id: NCT04455880
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Our aim was to investigate and compare placental elasticity by using Shear wave elastography
      (SWE) in patients with gestational diabetes mellitus (GDM) with and without insulin to
      non-diabetic controls.

      This prospective study included 319 pregnant patients. Three groups were created as follows:
      Group 1 (n= 79, GDM with insulin therapy), Group 2 (n=90, GDM with only diet) and Group 3 (n=
      150, healthy controls) All patients were above 36 gestational weeks with anterior placenta.
      Totally six measurements including the central and peripheral parts (right, left) of the
      placenta both from maternal and fetal sites were obtained with SWE. Demographic, obstetrics,
      fetal and perinatal features were also compared. Receiver operating characteristic analysis
      was plotted and cut-off of elastographic velocity values were noted
This prospective study included singleton pregnant women aged between 18-45 years who applied
      for third trimester prenatal examination (36 gestational weeks and above) between May 2019
      and December 2019 at Women and Children Disease Training and Research Hospital, Istanbul,
      Turkey. Ethical documents including Declaration of Helsinki were approved by local
      institutional review board (Approval number:49/2019) and a written informed consent was
      obtained from all patients. The study participants were divided into three groups according
      to treatments. While Group 1 consisted of patients with GDM using insulin therapy (GDM A2),
      patients with GDM treated with only diet (without any medical therapy) created Group 2 (GDM
      A1). Group 3 included healthy controls. Insulin therapy was initiated when target cut-off
      values were exceeded according to Carpenter and Coustan criteria. Patients with anterior
      placenta were included in the study because the effectiveness of the method decreased.
      Gestational age was recorded regarding last menstrual period and was checked in all
      participants by using a first trimester ultrasound report. All GDM patients were followed up
      in perinatology clinic and timing of delivery was organized individually basically on
      obstetrical indications. Ultrasonographic evaluation and SWE method were performed by single
      perinatologist Elastographic examinations were performed by physicians using Samsung HS70A
      ultrasound system with a Samsung CA1-7A convex transducer and S-Shear wave technique. During
      the examination, patients were lying in supine position, breathing levels kept steady to
      prevent noise and artifacts and minimum pressure were applied on the transducer to eliminate
      misleading tissue compression. A region of interest (ROI) box of 10 × 10 mm was positioned on
      placenta and six measurements were obtained from central and peripheral zones of placenta
      while avoiding vascular structures. Considering the disc-like structure of the placenta
      measurement areas were divided into six regions as follows: maternal right, maternal central,
      maternal left, fetal right, fetal central and fetal left. All measurements taken from
      different zones were recorded individually along with the mean value generated using IQR
      method. Through this approach, datasets were established not just for the auto-calculated
      mean value but also zone specific values for further analysis. All measurements were obtained
      in both kilopascal (kPa) and m/s formats.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group 1 (n= 79, GDM with insulin therapy), Group 2 (n=90, GDM with only diet), Group 3 (n= 150, healthy controls) All patients were above 36 gestational weeks with anterior placenta.
primary purpose: Other
masking: None (Open Label)
measure: Shear wave elastography in gestational diabetes mellitus
time frame: 9 months
description: To investigate and compare placental elasticity by using Shear wave elastography (SWE) in patients with gestational diabetes mellitus (GDM) with and without insulin to non-diabetic controls.
measure: Prediction and differentiation of GDM and prognosis with Shear wave elastography velocity cut-offs
time frame: 9 months
description: Cut off values of velocities will be estimated to predict GDM
arm group label: GDM with insulin therapy
arm group type: Active Comparator
description: Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.
arm group label: GDM treated with only diet (without any medical therapy)
arm group type: Active Comparator
description: Singleton pregnancies above 36 gestational weeks diagnosed Gestational Diabetes Mellitus and treated with insulin therapy.
arm group label: Non-diabetic Controls
arm group type: Active Comparator
description: Singleton non diabetic healthy pregnancies above 36 gestational weeks
intervention type: Other
intervention name: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity
description: SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity. The stiffer the tissue, the higher shear wave velocity is measured. Elastographic examinations were performed by physicians using Samsung HS70A ultrasound system with a Samsung CA1-7A convex transducer and S-Shear wave technique. During the examination, patients were lying in supine position, breathing levels kept steady to prevent noise and artifacts and minimum pressure were applied on the transducer to eliminate misleading tissue compression. A region of interest (ROI) box of 10 × 10 mm was positioned on placenta and six measurements were obtained from central and peripheral zones of placenta while avoiding vascular structures
arm group label: GDM treated with only diet (without any medical therapy)
arm group label: GDM with insulin therapy
arm group label: Non-diabetic Controls
criteria: 
gender: Female
gender based: Yes
gender description: Singleton 36 weeks of gestation with anterior placenta
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hicran Acar Sirinoglu, MD
role: Principal Investigator
affiliation: Zeynep Kamil Women and Children Disease Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Adana Numune Training and Research Hospital
investigator full name: Gulsum Uysal
investigator title: Associate Professor in Obstetrics and Gynecology Department
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: No