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

Active, not recruiting

• Conditions: Microbiome, Human
• Interventions: Drug: antibiotic

• Registration Number: NCT05738473
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-02-23
• Status Verified: 2023-01
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-02-12
• Last Update Submitted: 2023-02-12
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 492

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP	antibiotic	vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS)、Pregnant women undergoing IAP

Primary Outcome Measures

Name	Time	Method
Intestinal flora	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	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, Guang Dong, China