<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/NCT04451928</url>
  </required_header>
  <id_info>
    <org_study_id>2020/01-1</org_study_id>
    <nct_id>NCT04451928</nct_id>
  </id_info>
  <brief_title>Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour</brief_title>
  <official_title>Prediction of Preterm Delivery by Serum Ischemia Modified Albumin, Biglycan and Decorin Levels in Women With Threatened Preterm Labour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ismail Biyik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kutahya Health Sciences University</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>
      In this study, the levels of ischemia modified albumin, biglycan and decorin in the serums of&#xD;
      pregnant women hospitalized for preterm labor will be examined. Their serum levels will be&#xD;
      compared between women having preterm and term delivery. Their accuracy will be asessed in&#xD;
      predicting preterm birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 90 singleton pregnant women between the ages of 18 and 42 and&#xD;
      gestational ages of 24 and 37 weeks.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Singleton pregnancy&#xD;
&#xD;
        -  Gestational age between 24 and 37 weeks&#xD;
&#xD;
        -  Cervical dilatation less than 3 cm and cervical effacement less than 80%&#xD;
&#xD;
        -  Uterine contraction ≥3 times at 30 minutes&#xD;
&#xD;
        -  Intact amniotic membrane&#xD;
&#xD;
      Excusion criteria:&#xD;
&#xD;
        -  Multiple pregnancy&#xD;
&#xD;
        -  Preterm premature rupture of membranes&#xD;
&#xD;
        -  Abnormal placentation (such as placenta previa)&#xD;
&#xD;
        -  Uterin anomaly&#xD;
&#xD;
        -  Maternal heart disease&#xD;
&#xD;
        -  Inflammatory or infectious disease&#xD;
&#xD;
        -  Preeclampsia&#xD;
&#xD;
        -  Fetal growth restriction&#xD;
&#xD;
        -  Congenital fetal anomaly&#xD;
&#xD;
        -  Polyhydramnios&#xD;
&#xD;
        -  Acute chorioamnionitis&#xD;
&#xD;
        -  Medically induced preterm delivery&#xD;
&#xD;
      Patients who are hospitalized due to preterm labor will primarily receive bed rest and&#xD;
      hydration. If cervical changes persist or if contractions continue after 2 hours after&#xD;
      intravenous hydration, tocolytic treatment will be started. Calcium channel blockers will be&#xD;
      used as tocolytic drug. Maternal corticosteroid (12 mg intramuscular betamethasone within 24&#xD;
      hours) will be given to accelerate fetal lung development. After 48 hours after steroid&#xD;
      administration, tocolysis will be stopped. Demographic datas of the patients will be&#xD;
      recorded. Patients will be followed until delivery. The gestational week will be determined&#xD;
      according to the last menstrual date and will be confirmed by early ultrasonographic&#xD;
      measurements. The gestational week at birth and the time between admission to the hospital&#xD;
      and birth will be recorded. Delivery time will be divided into groups within 24 hours, 48&#xD;
      hours, 7 days, 14 days, and ≤37 weeks after admission. Mode of delivery, baby's birth weight,&#xD;
      APGAR score will be recorded.&#xD;
&#xD;
      Venous blood samples will be taken from patients before medication. Serum samples will be&#xD;
      stored in the cooler set to -80 °C until analysis. Levels of ischemia-modified albumin,&#xD;
      biglycan and decorin levels will be examined by enzyme-linked immunosorbent assay (ELISA)&#xD;
      method.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      After the assessment of the data, the variables between two groups will be compared by Mann&#xD;
      Whitney U test, Student T test, Fisher Exact Test, Chi-Square Analysis. Regression model will&#xD;
      be conducted in order to estimate the probability of the preterm birth. A value of p &lt; 0.05&#xD;
      will be considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">February 5, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>13 Months</target_duration>
  <primary_outcome>
    <measure>Gestational age at birth</measure>
    <time_frame>December 2019 - January 2021</time_frame>
    <description>Preterm: &lt;37 gestational week Term: ≥37 gestational week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital admission and delivery interval</measure>
    <time_frame>December 2019 - January 2021</time_frame>
    <description>Delivery time will be divided into groups within; 48 hours, 7 days, 14 days,&#xD;
35 weeks and&#xD;
37 weeks after hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>December 2019 - January 2021</time_frame>
    <description>Vaginal delivery Cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APGAR score</measure>
    <time_frame>December 2019 - January 2021</time_frame>
    <description>Apgar stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration.&quot; of newborn at 1 and 5 minutes after delivery.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>Preterm delivery</arm_group_label>
    <description>Pregnant women who give birth before 37th gestational week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Term delivery</arm_group_label>
    <description>Pregnant women who will give birth 37th and after gestational week</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum sample analysis</intervention_name>
    <description>Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels</description>
    <arm_group_label>Preterm delivery</arm_group_label>
    <arm_group_label>Term delivery</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are hospitalized due to preterm labor. Preterm labor is defined as regular&#xD;
        contractions (uterine contraction ≥3 times at 30 minutes) of the uterus resulting in&#xD;
        changes in the cervix that start before 37 weeks of pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Gestational age is between 24-37 weeks&#xD;
&#xD;
          -  Cervical dilatation less than 3 cm and cervical effacement less than 80%&#xD;
&#xD;
          -  Uterine contraction ≥3 times at 30 minutes&#xD;
&#xD;
          -  Intact amniotic membrane&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Preterm premature rupture of membranes&#xD;
&#xD;
          -  Abnormal placentation (such as placenta previa)&#xD;
&#xD;
          -  Uterine anomaly&#xD;
&#xD;
          -  Maternal heart disease&#xD;
&#xD;
          -  Inflammatory or infectious disease&#xD;
&#xD;
          -  Preeclampsia&#xD;
&#xD;
          -  Fetal growth restriction&#xD;
&#xD;
          -  Congenital fetal anomaly&#xD;
&#xD;
          -  Polyhydramnios&#xD;
&#xD;
          -  Acute chorioamnionitis&#xD;
&#xD;
          -  Medically induced preterm delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Singleton pregnant women between the ages of 18 and 42 and gestational ages of 24 and 37 weeks.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismail Biyik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kütahya Medical Sciences University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kütahya Medical Sciences University</name>
      <address>
        <city>Kütahya</city>
        <zip>43000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Rossi A, Bortolotti N, Vescovo S, Romanello I, Forzano L, Londero AP, Ambrosini G, Marchesoni D, Curcio F. Ischemia-modified albumin in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):348-51. doi: 10.1016/j.ejogrb.2013.06.037. Epub 2013 Jul 23.</citation>
    <PMID>23891063</PMID>
  </reference>
  <reference>
    <citation>Underhill LA, Avalos N, Tucker R, Zhang Z, Messerlian G, Lechner B. Serum Decorin and Biglycan as Potential Biomarkers to Predict PPROM in Early Gestation. Reprod Sci. 2019 Mar 21:1933719119831790. doi: 10.1177/1933719119831790. Online ahead of print.</citation>
    <PMID>30895897</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kutahya Health Sciences University</investigator_affiliation>
    <investigator_full_name>Ismail Biyik</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>preterm birth</keyword>
  <keyword>ischemia modified albumin</keyword>
  <keyword>biglycan</keyword>
  <keyword>decorin</keyword>
  <keyword>prediction</keyword>
  <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>Ischemia</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/NCT04451928
org study id: 2020/01-1
nct id: NCT04451928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the levels of ischemia modified albumin, biglycan and decorin in the serums of
      pregnant women hospitalized for preterm labor will be examined. Their serum levels will be
      compared between women having preterm and term delivery. Their accuracy will be asessed in
      predicting preterm birth.
The study will include 90 singleton pregnant women between the ages of 18 and 42 and
      gestational ages of 24 and 37 weeks.

      Inclusion criteria:

        -  Singleton pregnancy

        -  Gestational age between 24 and 37 weeks

        -  Cervical dilatation less than 3 cm and cervical effacement less than 80%

        -  Uterine contraction ≥3 times at 30 minutes

        -  Intact amniotic membrane

      Excusion criteria:

        -  Multiple pregnancy

        -  Preterm premature rupture of membranes

        -  Abnormal placentation (such as placenta previa)

        -  Uterin anomaly

        -  Maternal heart disease

        -  Inflammatory or infectious disease

        -  Preeclampsia

        -  Fetal growth restriction

        -  Congenital fetal anomaly

        -  Polyhydramnios

        -  Acute chorioamnionitis

        -  Medically induced preterm delivery

      Patients who are hospitalized due to preterm labor will primarily receive bed rest and
      hydration. If cervical changes persist or if contractions continue after 2 hours after
      intravenous hydration, tocolytic treatment will be started. Calcium channel blockers will be
      used as tocolytic drug. Maternal corticosteroid (12 mg intramuscular betamethasone within 24
      hours) will be given to accelerate fetal lung development. After 48 hours after steroid
      administration, tocolysis will be stopped. Demographic datas of the patients will be
      recorded. Patients will be followed until delivery. The gestational week will be determined
      according to the last menstrual date and will be confirmed by early ultrasonographic
      measurements. The gestational week at birth and the time between admission to the hospital
      and birth will be recorded. Delivery time will be divided into groups within 24 hours, 48
      hours, 7 days, 14 days, and ≤37 weeks after admission. Mode of delivery, baby's birth weight,
      APGAR score will be recorded.

      Venous blood samples will be taken from patients before medication. Serum samples will be
      stored in the cooler set to -80 °C until analysis. Levels of ischemia-modified albumin,
      biglycan and decorin levels will be examined by enzyme-linked immunosorbent assay (ELISA)
      method.

      Statistical analysis:

      After the assessment of the data, the variables between two groups will be compared by Mann
      Whitney U test, Student T test, Fisher Exact Test, Chi-Square Analysis. Regression model will
      be conducted in order to estimate the probability of the preterm birth. A value of p < 0.05
      will be considered statistically significant.
observational model: Cohort
time perspective: Prospective
measure: Gestational age at birth
time frame: December 2019 - January 2021
description: Preterm: <37 gestational week Term: ≥37 gestational week
measure: Hospital admission and delivery interval
time frame: December 2019 - January 2021
description: Delivery time will be divided into groups within; 48 hours, 7 days, 14 days,
35 weeks and
37 weeks after hospital admission.
measure: Mode of delivery
time frame: December 2019 - January 2021
description: Vaginal delivery Cesarean delivery
measure: APGAR score
time frame: December 2019 - January 2021
description: Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration." of newborn at 1 and 5 minutes after delivery.
arm group label: Preterm delivery
description: Pregnant women who give birth before 37th gestational week
arm group label: Term delivery
description: Pregnant women who will give birth 37th and after gestational week
intervention type: Diagnostic Test
intervention name: Serum sample analysis
description: Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels
arm group label: Preterm delivery
arm group label: Term delivery
Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Singleton pregnant women between the ages of 18 and 42 and gestational ages of 24 and 37 weeks.
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Ismail Biyik, MD
role: Principal Investigator
affiliation: Kütahya Medical Sciences University
facility: 
country: Turkey
citation: Rossi A, Bortolotti N, Vescovo S, Romanello I, Forzano L, Londero AP, Ambrosini G, Marchesoni D, Curcio F. Ischemia-modified albumin in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):348-51. doi: 10.1016/j.ejogrb.2013.06.037. Epub 2013 Jul 23.
PMID: 23891063
citation: Underhill LA, Avalos N, Tucker R, Zhang Z, Messerlian G, Lechner B. Serum Decorin and Biglycan as Potential Biomarkers to Predict PPROM in Early Gestation. Reprod Sci. 2019 Mar 21:1933719119831790. doi: 10.1177/1933719119831790. Online ahead of print.
PMID: 30895897
responsible party type: Sponsor-Investigator
investigator affiliation: Kutahya Health Sciences University
investigator full name: Ismail Biyik
investigator title: Assistant Professor
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
mesh term: Ischemia
sharing ipd: No