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Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome (CSBabyBiome)

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ClinicalTrials.gov Identifier: NCT06030713
Recruitment Status : Completed
First Posted : September 11, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
University Medical Center Groningen

Study Description
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Brief Summary:
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-).

Condition or disease Intervention/treatment Phase
Microbial Colonization Antibiotic Side Effect Cesarean Section Complications Drug: Cefazolin Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Timing of Umbilical Cord Clamping During an Elective Caesarean Delivery and Its Association With Neonatal Gut Microbiome.
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : October 1, 2022
Actual Study Completion Date : March 1, 2023

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cord clamped after antibiotic prophylaxis
Umbilical cord clamped after 1g of cephazolin
 Drug: Cefazolin
Cord clamping before or after antibiotic (cefazolin) prophylaxis
Other Names:
  • DB01327
  • J01DB04
Experimental: Cord clamped before antibiotic prophylaxis
Umbilical cord clamped before 1g of cephazolin
 Drug: Cefazolin
Cord clamping before or after antibiotic (cefazolin) prophylaxis
Other Names:
  • DB01327
  • J01DB04


Outcome Measures
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Primary Outcome Measures :
  1. Infant microbial species level differences between two groups [ Time Frame: First 6 weeks of life ]
    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

  2. Infant Alpha Diversity differences between two groups [ Time Frame: First 6 weeks of life ]
    Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups

  3. Infant Beta Diversity differences between two groups [ Time Frame: First 6 weeks of life ]
    Beta Diversity difference in Aitchison distances between the two intervention groups

  4. Infant Antibiotic Resistance total gene load differences between two groups [ Time Frame: First 6 weeks of life ]
    Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups


Secondary Outcome Measures :
  1. Number of participants with post c-section maternal wound infection [ Time Frame: First 6 weeks of life ]
    Number of participants with early and late post C-section wound infection in mothers


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females undergoing elective CS at the UMCG
  • Gestational age in weeks equal to or above 38 weeks

Exclusion Criteria:

  • Cephalosporin allergy
  • Exposure to antibiotic agent 2 weeks before CS
  • Temperature >37.5 C before CS
  • Pre-labour rupture of membranes
  • Emergency CS
  • No -20 freezer at home
  • No command of the Dutch language
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030713


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Trishla Sinha, MD University Medical Center Groningen
Principal Investigator: Alexandra Zhernakova, MD/PhD University Medical Center Groningen
More Information
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Responsible Party: University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT06030713    
Other Study ID Numbers: CS_Baby_Biome_2017/240
NL61493.042.17 ( Registry Identifier: ABR )
METc 2017.240 ( Other Identifier: METc )
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The sequencing data of the microbiome will be available for other researchers via EGA
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will become available upon publication
Access Criteria: Must fill in the form that the data will be used for research purposes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Disease Attributes
Pathologic Processes
 Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents