<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/NCT02187874</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AMI)18/2014</org_study_id>
    <secondary_id>PR(AMI)18/2014</secondary_id>
    <nct_id>NCT02187874</nct_id>
  </id_info>
  <brief_title>Timing of Umbilical Cord Occlusion in Premature Babies( &lt;33 w). Delayed vs Early.</brief_title>
  <acronym>CODE-P</acronym>
  <official_title>Timing of Umbilical Cord Occlusion in Premature Babies( &lt;33 w). Delayed vs Early.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early cord clamping after delivery has been common practice for many decades as part of the&#xD;
      active management of the third stage of labour. However in recent years, several studies have&#xD;
      shown that delayed cord clamping may offer important benefits to the newborn. The data&#xD;
      gathered indicate that delayed cord clamping may be particularly useful in premature babies,&#xD;
      between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the&#xD;
      incidence of intraventricular haemorrhage.&#xD;
&#xD;
      However it is argued that the described potential benefits of delayed cord clamping could be&#xD;
      negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by&#xD;
      potential interference with the postpartum haemorrhage management, initial care and&#xD;
      reanimation of the premature newborn, and the possibility of cord blood donation. These&#xD;
      factors, together with as the lack of homogeneity among existing studies regarding the&#xD;
      delayed cord clamping technique create the need, in our opinion, for further research, to&#xD;
      establish the proper place of this measure.&#xD;
&#xD;
      Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces&#xD;
      the need for blood transfusions and intraventricular haemorrhage, compared with usual early&#xD;
      cord clamping.&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
        -  To define the impact of delayed cord clamping on neonatal assessment parameters after&#xD;
           delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.&#xD;
&#xD;
        -  Neonatal mortality and morbidity&#xD;
&#xD;
        -  Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage&#xD;
&#xD;
        -  To study the correlation between Iron metabolism and reticulocitary haemoglobin levels&#xD;
           in cord and infant blood.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">July 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of red blood cell transfusions to the newborn</measure>
    <time_frame>for the duration of hospital stay, an expected average of 2 months.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraventricular Haemorrhage incidence</measure>
    <time_frame>from delivery, for the duration of hospital stay, an expected average of 2 months.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal postpartum haemorrhage incidence</measure>
    <time_frame>within 24 hours after birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of neonatal red blood cell transfusions</measure>
    <time_frame>for the duration of hospital stay, an expected average of 2 months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neonatal mortality</measure>
    <time_frame>up to 27 days after birth.</time_frame>
    <description>early ( 0 to 6 days after birth)&#xD;
late ( 7 to 27 days after birth)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>APGAR score</measure>
    <time_frame>10 minutes after delivery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Umbilical cord blood pH</measure>
    <time_frame>0-15 minutes after delivery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal intubation</measure>
    <time_frame>0-30 minutes after delivery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of intensive reanimation of the newborn</measure>
    <time_frame>0-30 minutes after delivery</time_frame>
    <description>Use of vasoactive drugs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of adverse events during hospital stay of the newborn.</measure>
    <time_frame>for the duration of hospital stay, an expected average of 2 month.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Delayed Umbilical Cord Clamping Benefits</condition>
  <condition>Postpartum Haemorrhage</condition>
  <condition>Intraventricular Haemorrhage</condition>
  <arm_group>
    <arm_group_label>early umbilical cord occlusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cord clamping will be performed before 30 seconds after delivery, annoting the exact time of clampage and initiating reanimation and postnatal care procedures as usual. 60 second after delivery of the new born, 10 IU of Oxytocin will be administered intramuscularly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>delayed umbilical cord occlusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One of the paediatricians will hold the newborn ( in vaginal deliveries between 20-30 cm under the mother, in C-sections between the legs of the mother) until clamping of the umbilical cord is indicated by a second paediatrician who will be controlling the time and overall state of the baby. The baby will be wrapped during this time in a thermal blanket in a flexed lateral decubitus position to minimise stress and heat loss. Time of clamping: after 30 to 60 seconds( preferably 60). If loss of the baby's wellbeing is suspected, the paediatrician will assess the newborn's heart rate , stopping the procedureif this falls under 100ppm, initiating at that moment the necessary reanimation procedures.&#xD;
60 second after the delivery of the new born 10 IU of oxytocin will be administered intramuscularly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>delayed umbilical cord occlusion</intervention_name>
    <arm_group_label>delayed umbilical cord occlusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>early umbilical cord occlusion</intervention_name>
    <arm_group_label>early umbilical cord occlusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <arm_group_label>delayed umbilical cord occlusion</arm_group_label>
    <arm_group_label>early umbilical cord occlusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Deliveries ( either vaginal or by C-section) between 26 and 32.6 weeks of gestation.&#xD;
&#xD;
          -  Patients must be over 18 years old.&#xD;
&#xD;
          -  Patient understands and signs informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urgent C-section&#xD;
&#xD;
          -  gestational age under 22 or over 33 weeks&#xD;
&#xD;
          -  Major fetal anomalies (requiring surgery or with a high risk of neonatal death or&#xD;
             incapacity)&#xD;
&#xD;
          -  Major uterine malformations&#xD;
&#xD;
          -  Placenta previa.&#xD;
&#xD;
          -  Multiple gestations&#xD;
&#xD;
          -  Fetal hydrops&#xD;
&#xD;
          -  Severe Iso- Immunization&#xD;
&#xD;
          -  HIV-positive mother&#xD;
&#xD;
          -  Severe Intrauterine growth restriction ( Reverse atrial Flow in DV)&#xD;
&#xD;
          -  Intrauterus Ventricular haemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melchor Carbonell Socias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela Gregoraci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Goya Canino, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Angeles Linde, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melchor Carbonell, MD</last_name>
    <phone>0034626470597</phone>
    <email>xormd11@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitari de la Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melchor Carbonell, MD</last_name>
      <phone>0034626470597</phone>
      <email>xormd11@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>April 23, 2016</last_update_submitted>
  <last_update_submitted_qc>April 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02187874
org study id: PR(AMI)18/2014
secondary id: PR(AMI)18/2014
nct id: NCT02187874
lead sponsor: 
has dmc: Yes
Early cord clamping after delivery has been common practice for many decades as part of the
      active management of the third stage of labour. However in recent years, several studies have
      shown that delayed cord clamping may offer important benefits to the newborn. The data
      gathered indicate that delayed cord clamping may be particularly useful in premature babies,
      between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the
      incidence of intraventricular haemorrhage.

      However it is argued that the described potential benefits of delayed cord clamping could be
      negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by
      potential interference with the postpartum haemorrhage management, initial care and
      reanimation of the premature newborn, and the possibility of cord blood donation. These
      factors, together with as the lack of homogeneity among existing studies regarding the
      delayed cord clamping technique create the need, in our opinion, for further research, to
      establish the proper place of this measure.

      Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces
      the need for blood transfusions and intraventricular haemorrhage, compared with usual early
      cord clamping.

      Secondary outcomes:

        -  To define the impact of delayed cord clamping on neonatal assessment parameters after
           delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.

        -  Neonatal mortality and morbidity

        -  Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage

        -  To study the correlation between Iron metabolism and reticulocitary haemoglobin levels
           in cord and infant blood.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of red blood cell transfusions to the newborn
time frame: for the duration of hospital stay, an expected average of 2 months.
measure: Intraventricular Haemorrhage incidence
time frame: from delivery, for the duration of hospital stay, an expected average of 2 months.
measure: Maternal postpartum haemorrhage incidence
time frame: within 24 hours after birth
measure: Volume of neonatal red blood cell transfusions
time frame: for the duration of hospital stay, an expected average of 2 months.
measure: Neonatal mortality
time frame: up to 27 days after birth.
description: early ( 0 to 6 days after birth)
late ( 7 to 27 days after birth)
measure: APGAR score
time frame: 10 minutes after delivery
measure: Umbilical cord blood pH
time frame: 0-15 minutes after delivery
measure: Neonatal intubation
time frame: 0-30 minutes after delivery
measure: Incidence of intensive reanimation of the newborn
time frame: 0-30 minutes after delivery
description: Use of vasoactive drugs.
measure: Incidence of adverse events during hospital stay of the newborn.
time frame: for the duration of hospital stay, an expected average of 2 month.
arm group label: early umbilical cord occlusion
arm group type: Active Comparator
description: Cord clamping will be performed before 30 seconds after delivery, annoting the exact time of clampage and initiating reanimation and postnatal care procedures as usual. 60 second after delivery of the new born, 10 IU of Oxytocin will be administered intramuscularly.
arm group label: delayed umbilical cord occlusion
arm group type: Experimental
description: One of the paediatricians will hold the newborn ( in vaginal deliveries between 20-30 cm under the mother, in C-sections between the legs of the mother) until clamping of the umbilical cord is indicated by a second paediatrician who will be controlling the time and overall state of the baby. The baby will be wrapped during this time in a thermal blanket in a flexed lateral decubitus position to minimise stress and heat loss. Time of clamping: after 30 to 60 seconds( preferably 60). If loss of the baby's wellbeing is suspected, the paediatrician will assess the newborn's heart rate , stopping the procedureif this falls under 100ppm, initiating at that moment the necessary reanimation procedures.
60 second after the delivery of the new born 10 IU of oxytocin will be administered intramuscularly.
intervention type: Procedure
intervention name: delayed umbilical cord occlusion
arm group label: delayed umbilical cord occlusion
intervention type: Procedure
intervention name: early umbilical cord occlusion
arm group label: early umbilical cord occlusion
intervention type: Drug
intervention name: Oxytocin
arm group label: delayed umbilical cord occlusion
arm group label: early umbilical cord occlusion
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Melchor Carbonell Socias, MD
role: Principal Investigator
affiliation: Hospital Vall d'Hebron
last name: Angela Gregoraci, MD
role: Principal Investigator
affiliation: Hospital Vall d'Hebron
last name: Maria Goya Canino, MD
role: Study Director
affiliation: Hospital Vall d'Hebron
last name: Maria Angeles Linde, MD
role: Study Director
affiliation: Hospital Vall d'Hebron
last name: Melchor Carbonell, MD
phone: 0034626470597
email: xormd11@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin