xml: <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/NCT06030713</url>
    </required_header>
    <id_info>
      <org_study_id>CS_Baby_Biome_2017/240</org_study_id>
      <secondary_id>NL61493.042.17</secondary_id>
      <secondary_id>METc 2017.240</secondary_id>
      <nct_id>NCT06030713</nct_id>
    </id_info>
    <brief_title>Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome</brief_title>
    <acronym>CSBabyBiome</acronym>
    <official_title>Timing of Umbilical Cord Clamping During an Elective Caesarean Delivery and Its Association With Neonatal Gut Microbiome.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medical Center Groningen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Medical Center Groningen</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, investigators seek to determine whether the timing of antibiotics given to&#xD;
        mothers during an elective C-section affects the composition of their infant's gut&#xD;
        microbiome. To do this, a randomized controlled trial (RCT) was carried out with women&#xD;
        undergoing elective C-sections. These women were either given antibiotics before the skin&#xD;
        incision (AB+) or after the umbilical cord was clamped (AB-).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: During a caesarean delivery, umbilical cord clamping can occur before or after&#xD;
        administering a perioperative prophylactic antibiotic to the mother. If the cord is clamped&#xD;
        before the antibiotic administration, this antibiotic cannot reach the infant. Conversely, if&#xD;
        the cord is clamped after the antibiotic administration, these maternal antibiotics cross the&#xD;
        placenta and enter the infant's circulation. In this study, investigators hypothesize that&#xD;
        such antibiotics modify the composition and functionality of the neonatal gut microbiome. A&#xD;
        changed neonatal microbiome associates with the onset of asthma, allergies, type 1 diabetes,&#xD;
        and obesity later in life. Such a small intervention could influence the future health of the&#xD;
        infant significantly.&#xD;
  &#xD;
        Objective: The primary aim of this study is to contrast the composition and functionality of&#xD;
        the neonatal gut microbiome from mothers given antibiotic prophylaxis before skin incision&#xD;
        with the microbiome of neonates from mothers given the antibiotic after umbilical cord&#xD;
        clamping during an elective caesarean delivery.&#xD;
  &#xD;
        Study design: Randomized controlled trial&#xD;
  &#xD;
        Study population: Pregnant women at &gt;38 weeks of gestation undergoing elective caesarean&#xD;
        section at the UMCG will be randomized into two groups. The gut microbiome of the neonates&#xD;
        from both groups will be analyzed.&#xD;
  &#xD;
        Intervention: The timing of umbilical cord clamping differs between the two groups. One gram&#xD;
        of Cefazolin (once, intravenous) will be administered to one group before skin incision,&#xD;
        while 1g cefazolin will be given to another group after umbilical cord clamping during an&#xD;
        elective caesarean section.&#xD;
  &#xD;
        Main study parameters/endpoints: The primary endpoint of this study is the variance in the&#xD;
        composition and functionality of the neonatal gut microbiome over a year, contrasting&#xD;
        neonates from mothers given antibiotic prophylaxis before skin incision with neonates from&#xD;
        mothers given the antibiotic after umbilical cord clamping.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2019</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">October 1, 2022</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>Timing of umbilical cord clamping is different in the two arms. One gram of Cefazolin (once, intravenous) will be given to one group of women before skin incision compared to 1g cefazolin given to another group of women after umbilical cord clamping during an elective caesarean section.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Infant microbial species level differences between two groups</measure>
      <time_frame>First 6 weeks of life</time_frame>
      <description>Centered log ratio transformed relative abundance differences of bacterial species (relative abundance of &gt; 0.05% and present in at least 2 infants) between two interventional groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Infant Alpha Diversity differences between two groups</measure>
      <time_frame>First 6 weeks of life</time_frame>
      <description>Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Infant Beta Diversity differences between two groups</measure>
      <time_frame>First 6 weeks of life</time_frame>
      <description>Beta Diversity difference in Aitchison distances between the two intervention groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Infant Antibiotic Resistance total gene load differences between two groups</measure>
      <time_frame>First 6 weeks of life</time_frame>
      <description>Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with post c-section maternal wound infection</measure>
      <time_frame>First 6 weeks of life</time_frame>
      <description>Number of participants with early and late post C-section wound infection in mothers</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">33</enrollment>
    <condition>Microbial Colonization</condition>
    <condition>Antibiotic Side Effect</condition>
    <condition>Cesarean Section Complications</condition>
    <arm_group>
      <arm_group_label>Cord clamped after antibiotic prophylaxis</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Umbilical cord clamped after 1g of cephazolin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cord clamped before antibiotic prophylaxis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Umbilical cord clamped before 1g of cephazolin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cefazolin</intervention_name>
      <description>Cord clamping before or after antibiotic (cefazolin) prophylaxis</description>
      <arm_group_label>Cord clamped after antibiotic prophylaxis</arm_group_label>
      <arm_group_label>Cord clamped before antibiotic prophylaxis</arm_group_label>
      <other_name>DB01327</other_name>
      <other_name>J01DB04</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Females undergoing elective CS at the UMCG&#xD;
  &#xD;
            -  Gestational age in weeks equal to or above 38 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cephalosporin allergy&#xD;
  &#xD;
            -  Exposure to antibiotic agent 2 weeks before CS&#xD;
  &#xD;
            -  Temperature &gt;37.5 C before CS&#xD;
  &#xD;
            -  Pre-labour rupture of membranes&#xD;
  &#xD;
            -  Emergency CS&#xD;
  &#xD;
            -  No -20 freezer at home&#xD;
  &#xD;
            -  No command of the Dutch language&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>1 Year</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Trishla Sinha, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Medical Center Groningen</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alexandra Zhernakova, MD/PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Medical Center Groningen</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University Medical Center Groningen</name>
        <address>
          <city>Groningen</city>
          <zip>9713 GZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cefazolin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The sequencing data of the microbiome will be available for other researchers via EGA</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will become available upon publication</ipd_time_frame>
      <ipd_access_criteria>Must fill in the form that the data will be used for research purposes.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030713
  org study id: CS_Baby_Biome_2017/240
  secondary id: NL61493.042.17
  secondary id: METc 2017.240
  nct id: NCT06030713
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, investigators seek to determine whether the timing of antibiotics given to
        mothers during an elective C-section affects the composition of their infant's gut
        microbiome. To do this, a randomized controlled trial (RCT) was carried out with women
        undergoing elective C-sections. These women were either given antibiotics before the skin
        incision (AB+) or after the umbilical cord was clamped (AB-).
  Rationale: During a caesarean delivery, umbilical cord clamping can occur before or after
        administering a perioperative prophylactic antibiotic to the mother. If the cord is clamped
        before the antibiotic administration, this antibiotic cannot reach the infant. Conversely, if
        the cord is clamped after the antibiotic administration, these maternal antibiotics cross the
        placenta and enter the infant's circulation. In this study, investigators hypothesize that
        such antibiotics modify the composition and functionality of the neonatal gut microbiome. A
        changed neonatal microbiome associates with the onset of asthma, allergies, type 1 diabetes,
        and obesity later in life. Such a small intervention could influence the future health of the
        infant significantly.
  
        Objective: The primary aim of this study is to contrast the composition and functionality of
        the neonatal gut microbiome from mothers given antibiotic prophylaxis before skin incision
        with the microbiome of neonates from mothers given the antibiotic after umbilical cord
        clamping during an elective caesarean delivery.
  
        Study design: Randomized controlled trial
  
        Study population: Pregnant women at >38 weeks of gestation undergoing elective caesarean
        section at the UMCG will be randomized into two groups. The gut microbiome of the neonates
        from both groups will be analyzed.
  
        Intervention: The timing of umbilical cord clamping differs between the two groups. One gram
        of Cefazolin (once, intravenous) will be administered to one group before skin incision,
        while 1g cefazolin will be given to another group after umbilical cord clamping during an
        elective caesarean section.
  
        Main study parameters/endpoints: The primary endpoint of this study is the variance in the
        composition and functionality of the neonatal gut microbiome over a year, contrasting
        neonates from mothers given antibiotic prophylaxis before skin incision with neonates from
        mothers given the antibiotic after umbilical cord clamping.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Timing of umbilical cord clamping is different in the two arms. One gram of Cefazolin (once, intravenous) will be given to one group of women before skin incision compared to 1g cefazolin given to another group of women after umbilical cord clamping during an elective caesarean section.
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Infant microbial species level differences between two groups
  time frame: First 6 weeks of life
  description: Centered log ratio transformed relative abundance differences of bacterial species (relative abundance of > 0.05% and present in at least 2 infants) between two interventional groups
  measure: Infant Alpha Diversity differences between two groups
  time frame: First 6 weeks of life
  description: Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups
  measure: Infant Beta Diversity differences between two groups
  time frame: First 6 weeks of life
  description: Beta Diversity difference in Aitchison distances between the two intervention groups
  measure: Infant Antibiotic Resistance total gene load differences between two groups
  time frame: First 6 weeks of life
  description: Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups
  measure: Number of participants with post c-section maternal wound infection
  time frame: First 6 weeks of life
  description: Number of participants with early and late post C-section wound infection in mothers
  arm group label: Cord clamped after antibiotic prophylaxis
  arm group type: Active Comparator
  description: Umbilical cord clamped after 1g of cephazolin
  arm group label: Cord clamped before antibiotic prophylaxis
  arm group type: Experimental
  description: Umbilical cord clamped before 1g of cephazolin
  intervention type: Drug
  intervention name: Cefazolin
  description: Cord clamping before or after antibiotic (cefazolin) prophylaxis
  arm group label: Cord clamped after antibiotic prophylaxis
  arm group label: Cord clamped before antibiotic prophylaxis
  other name: DB01327
  other name: J01DB04
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 1 Year
  healthy volunteers: Accepts Healthy Volunteers
  last name: Trishla Sinha, MD
  role: Principal Investigator
  affiliation: University Medical Center Groningen
  last name: Alexandra Zhernakova, MD/PhD
  role: Principal Investigator
  affiliation: University Medical Center Groningen
  facility: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Cefazolin
  sharing ipd: Yes
  ipd description: The sequencing data of the microbiome will be available for other researchers via EGA
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data will become available upon publication
  ipd access criteria: Must fill in the form that the data will be used for research purposes.