<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/NCT04459442</url>
  </required_header>
  <id_info>
    <org_study_id>3278/AT/14</org_study_id>
    <nct_id>NCT04459442</nct_id>
  </id_info>
  <brief_title>Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping</brief_title>
  <official_title>Placental Transfusion in the 'Natural' Vaginal Delivery at Term: Effect of Early and Late Umbilical Cord Clamping</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Policlinico Abano Terme</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Policlinico Abano Terme</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators conducted a randomized controlled trial (parallel group study with 1:1&#xD;
      randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping&#xD;
      (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in&#xD;
      a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of&#xD;
      circulating compounds, without potentially detrimental acidosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Placental transfusion supports an important blood transfer to the neonate,&#xD;
      promoting a more stable transition from fetal to extrauterine life, with the potential to&#xD;
      prevent iron deficiency in young children. Several studies have demonstrated that cord&#xD;
      clamping timing is greatly relevant for facilitate placental transfusion, the transfer of&#xD;
      extra blood from the placenta to the infant in the third stage of labor. Therefore, during'&#xD;
      natural', 'two-step delivery umbilical cord management may play a relevant role on blood&#xD;
      passage to the neonate and it may affect neonatal hematological values (placental&#xD;
      transfusion). The most effective way to manage umbilical cord in in 'natural', two-step&#xD;
      delivery remains to be established. Objective: The aim of the present study is to evaluate&#xD;
      the effect of two different methods of umbilical cord management ECC vs. DCC) on the&#xD;
      placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and&#xD;
      capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary&#xD;
      outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.&#xD;
&#xD;
      Material and methods: This is a randomized clinical trial on the effect of different cord&#xD;
      management in newborns by 'natural', two-step delivery. After obtaining parental consent, all&#xD;
      mothers &gt; 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio,&#xD;
      according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope&#xD;
      containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes&#xD;
      after delivery).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2021</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>Parallel Assignment The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomization), comparing early cord clamping (at 60 seconds) and delayed cord clamping (at 180 seconds) in 90 cases of 'normal', two-step vaginal births.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>None (Open Label)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Placental transfusion.</measure>
    <time_frame>Second day of life</time_frame>
    <description>Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cord blood pH</measure>
    <time_frame>Second day of life.</time_frame>
    <description>pH estimate in arterial cord blood gas analysis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Hematocrit Anemia</condition>
  <condition>Acidosis</condition>
  <arm_group>
    <arm_group_label>Early cord clamping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cord clamping at 60 seconds after birth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed cord clamping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cord clamping at 180 seconds after birth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Umbilical cord clamping at birth.</intervention_name>
    <description>Umbilical cord clamping after delivery.</description>
    <arm_group_label>Delayed cord clamping</arm_group_label>
    <arm_group_label>Early cord clamping</arm_group_label>
    <other_name>Cord clamping</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Vaginal delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cesarean delivery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>2 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Policlinico Abano Terme</name>
      <address>
        <city>Abano Terme</city>
        <state>Padua</state>
        <zip>35031</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Abano Terme</name>
      <address>
        <city>Abano Terme</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Padua University Hospital</name>
      <address>
        <city>Padua</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 15, 2021</last_update_submitted>
  <last_update_submitted_qc>September 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Policlinico Abano Terme</investigator_affiliation>
    <investigator_full_name>Vincenzo Zanardo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Placental transfusion</keyword>
  <keyword>Natural, two-step delivery</keyword>
  <keyword>Early cord clamping</keyword>
  <keyword>Delayed cord clamping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No. 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/NCT04459442
org study id: 3278/AT/14
nct id: NCT04459442
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators conducted a randomized controlled trial (parallel group study with 1:1
      randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping
      (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in
      a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of
      circulating compounds, without potentially detrimental acidosis.
Introduction: Placental transfusion supports an important blood transfer to the neonate,
      promoting a more stable transition from fetal to extrauterine life, with the potential to
      prevent iron deficiency in young children. Several studies have demonstrated that cord
      clamping timing is greatly relevant for facilitate placental transfusion, the transfer of
      extra blood from the placenta to the infant in the third stage of labor. Therefore, during'
      natural', 'two-step delivery umbilical cord management may play a relevant role on blood
      passage to the neonate and it may affect neonatal hematological values (placental
      transfusion). The most effective way to manage umbilical cord in in 'natural', two-step
      delivery remains to be established. Objective: The aim of the present study is to evaluate
      the effect of two different methods of umbilical cord management ECC vs. DCC) on the
      placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and
      capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary
      outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.

      Material and methods: This is a randomized clinical trial on the effect of different cord
      management in newborns by 'natural', two-step delivery. After obtaining parental consent, all
      mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio,
      according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope
      containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes
      after delivery).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomization), comparing early cord clamping (at 60 seconds) and delayed cord clamping (at 180 seconds) in 90 cases of 'normal', two-step vaginal births.
primary purpose: Basic Science
masking: Single (Investigator)
masking description: None (Open Label)
measure: Placental transfusion.
time frame: Second day of life
description: Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.
measure: Cord blood pH
time frame: Second day of life.
description: pH estimate in arterial cord blood gas analysis
arm group label: Early cord clamping
arm group type: Experimental
description: Cord clamping at 60 seconds after birth.
arm group label: Delayed cord clamping
arm group type: Experimental
description: Cord clamping at 180 seconds after birth.
intervention type: Procedure
intervention name: Umbilical cord clamping at birth.
description: Umbilical cord clamping after delivery.
arm group label: Delayed cord clamping
arm group label: Early cord clamping
other name: Cord clamping
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 2 Days
healthy volunteers: No
facility: 
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Policlinico Abano Terme
investigator full name: Vincenzo Zanardo
investigator title: Professor
mesh term: Acidosis
sharing ipd: No
ipd description: No. There is not a plan to make IPD available