The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Maternal Vaginal Microbiome, Intestinal Microbiome and Immunity of Offspring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Intestinal flora
研究概览
简要总结
In view of the current status of prevention and research on GBS disease in mothers and infants at home and abroad, this project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.
详细描述
This project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women are 18 to 40 years;
- •35 to 41 weeks of pregnancy;
- •Singleton pregnancy;
- •Plan for vaginal delivery and postpartum care in the research hospital;
- •Pregnant women who volunteered to participate in the study.
排除标准
- •Have infectious diseases, serious infections and clinical diseases;
- •Use of antibiotics in the past 2 weeks;
- •Long-term use of drugs due to digestion, immunity, blood, chronic diseases;
- •Sexual behavior, vaginal douching and topical medication within 24 hours before sampling;
- •Any medical or non-medical condition that the investigator considers inappropriate to participate.
研究组 & 干预措施
pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP
vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS)、Pregnant women undergoing IAP
干预措施: antibiotic (Drug)
结局指标
主要结局
Intestinal flora
时间窗: The offspring are born on the 42nd day after birth
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring.
Secretory IgA
时间窗: The offspring are born on the 42nd day after birth
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Calprotectin
时间窗: The offspring are born on the 42nd day after birth
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
次要结局
- The effect of IAP to prevent GBS-EOD.(Vaginal flora on days 42nd after delivery.)
- The characteristics of vaginal microbiome of pregnant women.(Vaginal flora on days 42nd after delivery.)