CSBabyBiome: Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome
Study Details
Study Description
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 |
|---|---|---|
| N/A |
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
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Infant microbial species level differences between two groups [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
- Infant Alpha Diversity differences between two groups [First 6 weeks of life]
Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups
- Infant Beta Diversity differences between two groups [First 6 weeks of life]
Beta Diversity difference in Aitchison distances between the two intervention groups
- Infant Antibiotic Resistance total gene load differences between two groups [First 6 weeks of life]
Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups
Secondary Outcome Measures
- Number of participants with post c-section maternal wound infection [First 6 weeks of life]
Number of participants with early and late post C-section wound infection in mothers
Eligibility Criteria
Criteria
Inclusion Criteria:
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Females undergoing elective CS at the UMCG
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Gestational age in weeks equal to or above 38 weeks
Exclusion Criteria:
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Cephalosporin allergy
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Exposure to antibiotic agent 2 weeks before CS
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Temperature >37.5 C before CS
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Pre-labour rupture of membranes
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Emergency CS
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No -20 freezer at home
-
No command of the Dutch language
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Groningen | Groningen | Netherlands | 9713 GZ |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: Trishla Sinha, MD, University Medical Center Groningen
- Principal Investigator: Alexandra Zhernakova, MD/PhD, University Medical Center Groningen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS_Baby_Biome_2017/240
- NL61493.042.17
- METc 2017.240