<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/NCT02229162</url>
  </required_header>
  <id_info>
    <org_study_id>400656-4</org_study_id>
    <nct_id>NCT02229162</nct_id>
  </id_info>
  <brief_title>Delayed Umbilical Cord Clamping - C-section Pilot</brief_title>
  <official_title>Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to&#xD;
      120 seconds) during elective cesarean deliveries of term infants. The investigators&#xD;
      hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this&#xD;
      procedure for mothers and babies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord&#xD;
      clamping remains a common obstetrical practice. The World Health Organization has noted that&#xD;
      data on cesarean deliveries are more limited, particularly with respect to long-term effects&#xD;
      in infants. Recently, the American College of Obstetrics and Gynecology also noted in a&#xD;
      committee statement that &quot; the ideal time for clamping of the umbilical cord in cesarean&#xD;
      section vs. vaginal birth is a particularly important area for future research&quot;.&#xD;
&#xD;
      The objective of this study is to conduct a pilot trial of delayed cord clamping during&#xD;
      cesarean deliveries to determine if progressively longer intervals of cord clamping are&#xD;
      feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes&#xD;
      from historical controls. We will offer study entry for women planning elective cesarean&#xD;
      delivery to collect prospective data on progressively longer intervals, analyzing outcomes&#xD;
      for each time interval to ensure they are clinically acceptable, prior to extending the&#xD;
      interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec)&#xD;
      and will perform hemoglobin analysis on the infants specifically for this study. If&#xD;
      intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the&#xD;
      cord will be clamped.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>maternal estimated blood loss (EBL)</measure>
    <time_frame>at delivery (approximately 1 hour duration)</time_frame>
    <description>Excessive EBL will be assessed by three measures&#xD;
clinical assessment by anesthesia/obstetrics after surgery noting amount of blood suctioned and on drapes, to include weighing of drapes at &gt; 800 mL&#xD;
difference between pre- and post-op hemoglobin levels of &gt; 20% more than that in baseline data&#xD;
need for transfusion,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neonatal hypothermia</measure>
    <time_frame>at admission (within 30 minutes of birth)</time_frame>
    <description>moderate or severe neonatal hypothermia (36.2 rectal or less)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>newborn hemoglobin concentration and hematocrit</measure>
    <time_frame>first day of life (0-24 h of age)</time_frame>
    <description>mean hemoglobin concentration and incidence of polycythemia (hct &gt;65 with symptoms, 70 without symptoms) and anemia (hgb &lt;14.5 g/dL)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>phototherapy</measure>
    <time_frame>&lt; 14 days of age</time_frame>
    <description>phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal intensive care (NICU) 'observation' or admission</measure>
    <time_frame>birth hospitalization (first 72 h of age approximately)</time_frame>
    <description>NICU 'observation' during transition or admission will be measured and reason for admission. respiratory symptoms are most of interest, but historical controls will only have data yes/no so we will look at overall nicu admissions also.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Cesarean Sections</condition>
  <arm_group>
    <arm_group_label>90 seconds DCC</arm_group_label>
    <description>the initial 15-20 subjects (15 enrolled subjects who complete study) will have cord clamped at 90 seconds. Then data will be analyzed and evaluated by DSMB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two minutes DCC</arm_group_label>
    <description>If Data Safety Monitoring Board (DSMB) concurs, DCC will then be practiced for 2 minutes for second group, which is the minimum amount of time recommended to be defined as DCC.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women 18 years of age or older that plan on having an elective Cesarean delivery&#xD;
        of a term singleton infant.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Subjects that are pregnant (women 18 years of age and older) and&#xD;
        scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant women that do not plan on having a C-section and individuals that are not&#xD;
        pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes&#xD;
        mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth&#xD;
        retardation will be excluded. Adults unable to consent will not be included&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Chantry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>umbilical cord</keyword>
  <keyword>cesarean section</keyword>
  <keyword>Blood Loss, Surgical</keyword>
  <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/NCT02229162
org study id: 400656-4
nct id: NCT02229162
lead sponsor: 
has dmc: Yes
This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to
      120 seconds) during elective cesarean deliveries of term infants. The investigators
      hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this
      procedure for mothers and babies.
Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord
      clamping remains a common obstetrical practice. The World Health Organization has noted that
      data on cesarean deliveries are more limited, particularly with respect to long-term effects
      in infants. Recently, the American College of Obstetrics and Gynecology also noted in a
      committee statement that " the ideal time for clamping of the umbilical cord in cesarean
      section vs. vaginal birth is a particularly important area for future research".

      The objective of this study is to conduct a pilot trial of delayed cord clamping during
      cesarean deliveries to determine if progressively longer intervals of cord clamping are
      feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes
      from historical controls. We will offer study entry for women planning elective cesarean
      delivery to collect prospective data on progressively longer intervals, analyzing outcomes
      for each time interval to ensure they are clinically acceptable, prior to extending the
      interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec)
      and will perform hemoglobin analysis on the infants specifically for this study. If
      intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the
      cord will be clamped.
observational model: Other
time perspective: Other
measure: maternal estimated blood loss (EBL)
time frame: at delivery (approximately 1 hour duration)
description: Excessive EBL will be assessed by three measures
clinical assessment by anesthesia/obstetrics after surgery noting amount of blood suctioned and on drapes, to include weighing of drapes at > 800 mL
difference between pre- and post-op hemoglobin levels of > 20% more than that in baseline data
need for transfusion,
measure: neonatal hypothermia
time frame: at admission (within 30 minutes of birth)
description: moderate or severe neonatal hypothermia (36.2 rectal or less)
measure: newborn hemoglobin concentration and hematocrit
time frame: first day of life (0-24 h of age)
description: mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)
measure: phototherapy
time frame: < 14 days of age
description: phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life
measure: Neonatal intensive care (NICU) 'observation' or admission
time frame: birth hospitalization (first 72 h of age approximately)
description: NICU 'observation' during transition or admission will be measured and reason for admission. respiratory symptoms are most of interest, but historical controls will only have data yes/no so we will look at overall nicu admissions also.
arm group label: 90 seconds DCC
description: the initial 15-20 subjects (15 enrolled subjects who complete study) will have cord clamped at 90 seconds. Then data will be analyzed and evaluated by DSMB
arm group label: Two minutes DCC
description: If Data Safety Monitoring Board (DSMB) concurs, DCC will then be practiced for 2 minutes for second group, which is the minimum amount of time recommended to be defined as DCC.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline Chantry, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No