Author: Trishla Sinha
Description: The scripts in this folder describes all the codes for the upstream, downstream and statistical analysis for the randomized clinical trial CS BABY BIOME. The study protocol (CCMO: NL61493.042.17) was approved by the medical ethics committee of the University Medical Center Groningen (2017/240). It is registered at ClinicalTrials.gov with ID: NCT06030713
Brief summary: In this study, investigators sought 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-).
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 was 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 were randomized into two groups. The gut microbiome of the neonates from both groups were anlyzed. In addition to this, the short chain fally acids and bile acids in the feces of these infants were quantified and compared.
Intervention: The timing of umbilical cord clamping differed between the two groups. One gram of Cefazolin (once, intravenous) was administered to one group before skin incision, while 1g cefazolin was given to the other group after umbilical cord clamping during an elective caesarean section.
Main study parameters/endpoints: The primary endpoint of this study was the difference 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.