Clinical trial NCT06030713: Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome
Official title: Timing of Umbilical Cord Clamping During an Elective Caesarean Delivery and Its Association With Neonatal Gut Microbiome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Antibiotic Side Effect
Cesarean Section Complications
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 33
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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-).

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.

Eligibility 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

Primary outcomes:
measure: Infant microbial species level differences between two groups
timeFrame: First 6 weeks of life
measure: Infant Alpha Diversity differences between two groups
timeFrame: First 6 weeks of life
measure: Infant Beta Diversity differences between two groups
timeFrame: First 6 weeks of life
measure: Infant Antibiotic Resistance total gene load differences between two groups
timeFrame: First 6 weeks of life
Secondary outcomes:
measure: Number of participants with post c-section maternal wound infection
timeFrame: First 6 weeks of life
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Trishla Sinha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Alexandra Zhernakova, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: