Effects of IAP-EOGBSD on Maternal Vaginal Microbiome, Offspring's Gut Microbiome and Metabolites.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Maternal Vaginal Microbiome, Intestinal Microbiome and Immunity of Offspring

Conditions
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Microbiome, Human

Intervention / Treatment
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* Drug: antibiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP<br>vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS)、Pregnant women undergoing IAP | Drug: antibiotic<br>* For pregnant women with GBS colonization, antibiotics are used to prevent infection<br>|
| pregnant women does not colonized by Group B Streptococcus (GBS) and not undergoing IAP<br>Group B streptococcus (GBS) does not colonize the vaginal microbiome of pregnant women、Pregnant wome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal flora | Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring. | The offspring are born on the 3rd day after birth | 
| Secretory IgA | Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring. | The offspring are born on the 3rd day after birth | 
| Calprotectin | Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring. | The offspring are born on the 3rd day after birth | 
| Intestinal flora | Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring. | The offspring are born on the 42nd day after birth | 
| Secretory IgA | Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring. | The offspring are born on the 42nd day after birth | 
| Calprotectin | Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring. | The offspring are born on the 42nd day after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of IAP to prevent GBS-EOD. | Analyze the effect of IAP (intrapartum antibiotics prophylaxis) to prevent GBS-EOD on maternal vaginal microbiome. | Vaginal flora on days 3rd after delivery. | 
| The characteristics of vaginal microbiome of pregnant women. | Analyze the characteristics of vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS). | Vaginal flora on days 3rd after delivery. | 
| The effect of IAP to prevent GBS-EOD. | Analyze the effect of IAP (intrapartum antibiotics prophylaxis) to prevent GBS-EOD on maternal vaginal microbiome. | Vaginal flora on days 42nd after delivery. | 
| The characteristics of vaginal microbiome of pregnant women. | Analyze the characteristics of vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS). | Vaginal flora on days 42nd after delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome,, maternal and offspring, healthy, whole genome sequencing of GBS strain., GBS test by(Q-PCR)