Timing of Umbilical Cord Clamping During an Elective Caesarean Delivery and Its Association With Neonatal Gut Microbiome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Infant Beta Diversity differences between two groups
研究概览
简要总结
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-).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females undergoing elective CS at the UMCG
- •Gestational age in weeks equal to or above 38 weeks
排除标准
- •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
研究组 & 干预措施
Cord clamped after antibiotic prophylaxis
Umbilical cord clamped after 1g of cephazolin
干预措施: Cefazolin (Drug)
Cord clamped before antibiotic prophylaxis
Umbilical cord clamped before 1g of cephazolin
干预措施: Cefazolin (Drug)
结局指标
主要结局
Infant Beta Diversity differences between two groups
时间窗: First 6 weeks of life
Beta Diversity difference in Aitchison distances between the two intervention groups
Infant Antibiotic Resistance total gene load differences between two groups
时间窗: First 6 weeks of life
Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups
Infant microbial species level differences between two groups
时间窗: 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
Infant Alpha Diversity differences between two groups
时间窗: First 6 weeks of life
Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups
次要结局
- Number of participants with post c-section maternal wound infection(First 6 weeks of life)