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

NCT06030713 | Completed

• 3 other identifiers: CS_Baby_Biome_2017/240NL61493.042.17METc 2017.240
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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-).

Conditions

Microbial Colonization; Antibiotic Side Effect; Cesarean Section Complications

Outcome Measures

Primary Outcomes (4)

• Infant microbial species level differences between two groups

  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

  First 6 weeks of life

• Infant Alpha Diversity differences between two groups

  Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups

  First 6 weeks of life

• Infant Beta Diversity differences between two groups

  Beta Diversity difference in Aitchison distances between the two intervention groups

  First 6 weeks of life

• Infant Antibiotic Resistance total gene load differences between two groups

  Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups

  First 6 weeks of life

Secondary Outcomes (1)

• Number of participants with post c-section maternal wound infection

  First 6 weeks of life

Study Arms (2)

Cord clamped after antibiotic prophylaxis

ACTIVE COMPARATOR

Umbilical cord clamped after 1g of cephazolin

Drug: Cefazolin

Cord clamped before antibiotic prophylaxis

EXPERIMENTAL

Umbilical cord clamped before 1g of cephazolin

Drug: Cefazolin

Interventions

Cefazolin DRUG

Cord clamping before or after antibiotic (cefazolin) prophylaxis

Also known as: DB01327, J01DB04

Cord clamped after antibiotic prophylaxis; Cord clamped before antibiotic prophylaxis

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Trishla Sinha, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Alexandra Zhernakova, MD/PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 11, 2023
• Study Start: March 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: March 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

NL (1)