<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/NCT04463485</url>
  </required_header>
  <id_info>
    <org_study_id>Delayed Cord Clamping RCT</org_study_id>
    <nct_id>NCT04463485</nct_id>
  </id_info>
  <brief_title>Impact of Umbilical Cord Clamping Time on Infant Anemia</brief_title>
  <official_title>Impact of Umbilical Cord Clamping Time on Infant Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mersin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mersin University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research was conducted to carry out the effect of umbilical cord clamping time on baby&#xD;
      anemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an experimental, randomized controlled study. The sample of the study consisted&#xD;
      of 65 pregnant women and newborns (intervention=32, control=33) who applied for delivery at&#xD;
      Ege University Medical Hospital Gynecology and Obstetrics Clinic at the time of the study. In&#xD;
      this study, &quot;Descriptive Data Form of Impact of Umbilical Cord Clamping Time on Infant&#xD;
      Anemia&quot; was used as a data collection tool. In the intervention group waited 60 seconds for&#xD;
      umbilical cord clamping in the second stage of labor, in the control group the umbilical cord&#xD;
      was clamped in the first 15 seconds. For the data of the first stage of the study, the&#xD;
      neonatal hematocrit and bilirubin measurements and the need for phototherapy due to&#xD;
      hyperbilirubinemia were evaluated 48 hours after birth. In the second stage of the study,&#xD;
      data on anaemia screening performed in family medicine at the end of the fourth month of&#xD;
      birth were examined. Statistical analysis of the data from the study was performed using IBM&#xD;
      SPSS Statistics 25.0 package program. Parametric tests were used for statistical analysis of&#xD;
      the data with a normal distribution. The level of statistical significance was determined as&#xD;
      p&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal Haematocrit Value at 48th Hours of Life</measure>
    <time_frame>48th hours after birth</time_frame>
    <description>Haematocrit measurement in capillary blood taken from newborn after birth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neonatal Bilirubin Value at 48th Hours of Life</measure>
    <time_frame>48th hours after birth</time_frame>
    <description>Bilirubin measurement in capillary blood taken from newborn after birth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phototherapy Requirement Rates due to Hyperbilirubinemia</measure>
    <time_frame>3 or 14 days of age</time_frame>
    <description>Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Haemoglobin Values of 4 Month Infants</measure>
    <time_frame>Infants' 4th month of age</time_frame>
    <description>Haemoglobin measurement at baby's 4th month of age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Haematocrit Values of 4 Month Infants</measure>
    <time_frame>Infants' 4th month of age</time_frame>
    <description>Haematocrit measurement at baby's 4th month of age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosis of Anemia Rates of 4 Month Infants</measure>
    <time_frame>Infants' 4th month of age</time_frame>
    <description>Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Third Stage of Labor</condition>
  <condition>Healthy</condition>
  <condition>Umbilical Cord Clamping Time</condition>
  <condition>Infant Conditions</condition>
  <arm_group>
    <arm_group_label>Delayed Clamping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Clamping</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No interventions have been assigned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed Clamping</intervention_name>
    <description>Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.</description>
    <arm_group_label>Delayed Clamping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apply for normal birth&#xD;
&#xD;
          -  Singleton pregnancy and live fetus&#xD;
&#xD;
          -  Cephalic presentation&#xD;
&#xD;
          -  Estimated birth weight between 2500-4000 grams&#xD;
&#xD;
          -  Birth rates &lt;5&#xD;
&#xD;
          -  Women who received iron support during pregnancy&#xD;
&#xD;
          -  Haemoglobin level ≥ 11 gr/dL&#xD;
&#xD;
          -  No systemic disease or pregnancy complication that may pose a risk for postpartum&#xD;
             bleeding.&#xD;
&#xD;
          -  Neonates who don't need for resuscitation after birth&#xD;
&#xD;
          -  Babies who did not receive iron supplements up to the 4th month after birth were&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who refuse to participate in the research&#xD;
&#xD;
          -  Neonates who need for resuscitation after birth&#xD;
&#xD;
          -  Babies who receive iron supplements up to the 4th month after birth were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Birsen Saydam</last_name>
    <role>Study Director</role>
    <affiliation>Ege University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ege University Medical Hospital Obstetric and Gynecology Department</name>
      <address>
        <city>İzmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mersin University</investigator_affiliation>
    <investigator_full_name>Sevil Güner</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>umbilical cord</keyword>
  <keyword>clamping</keyword>
  <keyword>infant</keyword>
  <keyword>anemia</keyword>
  <keyword>midwifery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </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/NCT04463485
org study id: Delayed Cord Clamping RCT
nct id: NCT04463485
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research was conducted to carry out the effect of umbilical cord clamping time on baby
      anemia.
This study is an experimental, randomized controlled study. The sample of the study consisted
      of 65 pregnant women and newborns (intervention=32, control=33) who applied for delivery at
      Ege University Medical Hospital Gynecology and Obstetrics Clinic at the time of the study. In
      this study, "Descriptive Data Form of Impact of Umbilical Cord Clamping Time on Infant
      Anemia" was used as a data collection tool. In the intervention group waited 60 seconds for
      umbilical cord clamping in the second stage of labor, in the control group the umbilical cord
      was clamped in the first 15 seconds. For the data of the first stage of the study, the
      neonatal hematocrit and bilirubin measurements and the need for phototherapy due to
      hyperbilirubinemia were evaluated 48 hours after birth. In the second stage of the study,
      data on anaemia screening performed in family medicine at the end of the fourth month of
      birth were examined. Statistical analysis of the data from the study was performed using IBM
      SPSS Statistics 25.0 package program. Parametric tests were used for statistical analysis of
      the data with a normal distribution. The level of statistical significance was determined as
      p<0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Neonatal Haematocrit Value at 48th Hours of Life
time frame: 48th hours after birth
description: Haematocrit measurement in capillary blood taken from newborn after birth
measure: Neonatal Bilirubin Value at 48th Hours of Life
time frame: 48th hours after birth
description: Bilirubin measurement in capillary blood taken from newborn after birth
measure: Phototherapy Requirement Rates due to Hyperbilirubinemia
time frame: 3 or 14 days of age
description: Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period
measure: Haemoglobin Values of 4 Month Infants
time frame: Infants' 4th month of age
description: Haemoglobin measurement at baby's 4th month of age
measure: Haematocrit Values of 4 Month Infants
time frame: Infants' 4th month of age
description: Haematocrit measurement at baby's 4th month of age
measure: Diagnosis of Anemia Rates of 4 Month Infants
time frame: Infants' 4th month of age
description: Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age
arm group label: Delayed Clamping
arm group type: Experimental
description: The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.
arm group label: Early Clamping
arm group type: No Intervention
description: No interventions have been assigned.
intervention type: Procedure
intervention name: Delayed Clamping
description: Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.
arm group label: Delayed Clamping
criteria: 
gender: All
minimum age: 19 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Birsen Saydam
role: Study Director
affiliation: Ege University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Mersin University
investigator full name: Sevil Güner
investigator title: Research Assistant
mesh term: Anemia
sharing ipd: No
ipd description: There is not a plan to make IPD available.