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

Cesarean Section Complications Clinical Trial

— CSBabyBiome  

Official title:

Timing of Umbilical Cord Clamping During an Elective Caesarean Delivery and Its Association With Neonatal Gut Microbiome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06030713
• Other study ID #: CS_Baby_Biome_2017/240
• Secondary ID: NL61493.042.17ME
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: September 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Cesarean Section Complications
• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Drug:
• Cefazolin
Cord clamping before or after antibiotic (cefazolin) prophylaxis

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Infant Beta Diversity differences between two groups	Beta Diversity difference in Aitchison distances between the two intervention groups	First 6 weeks of life
Primary	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	Number of participants with post c-section maternal wound infection	Number of participants with early and late post C-section wound infection in mothers	First 6 weeks of life