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Completed

NCT Number: NCT06030713

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

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-).

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Key information

Conditions

Microbial Colonization Antibiotic Side Effect Cesarean Section Complications Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

Cord clamping before or after antibiotic (cefazolin) prophylaxis

Other names: DB01327, J01DB04

Primary outcomes

  1. Infant microbial species level differences between two groups

    Time frame: 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

  2. Infant Alpha Diversity differences between two groups

    Time frame: First 6 weeks of life

    Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups

  3. Infant Beta Diversity differences between two groups

    Time frame: First 6 weeks of life

    Beta Diversity difference in Aitchison distances between the two intervention groups

  4. Infant Antibiotic Resistance total gene load differences between two groups

    Time frame: First 6 weeks of life

    Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups

Secondary outcomes

  1. Number of participants with post c-section maternal wound infection

    Time frame: First 6 weeks of life

    Number of participants with early and late post C-section wound infection in mothers

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: CSBabyBiome

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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