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

NCT ID: NCT06030713

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-03-01

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.

Conditions

Microbial Colonization; Antibiotic Side Effect; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cord clamped after antibiotic prophylaxis

Umbilical cord clamped after 1g of cephazolin

Group Type: ACTIVE_COMPARATOR

Cefazolin

Intervention Type: DRUG

Cord clamping before or after antibiotic (cefazolin) prophylaxis

Cord clamped before antibiotic prophylaxis

Umbilical cord clamped before 1g of cephazolin

Group Type: EXPERIMENTAL

Cefazolin

Intervention Type: DRUG

Cord clamping before or after antibiotic (cefazolin) prophylaxis

Interventions

Cefazolin

Cord clamping before or after antibiotic (cefazolin) prophylaxis

Intervention Type: DRUG

Other Intervention Names

DB01327; J01DB04

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

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trishla Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Alexandra Zhernakova, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

NL61493.042.17

Identifier Type: REGISTRY

Identifier Source: secondary_id

METc 2017.240

Identifier Type: OTHER

Identifier Source: secondary_id

CS_Baby_Biome_2017/240

Identifier Type: -

Identifier Source: org_study_id