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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Microbiome, Human
• Intervention / Treatment: Drug: antibiotic

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 Type: Observational
• Enrollment (Anticipated): 492

Contacts and Locations

Study Locations

• China
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510280
      • Zhujiang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

1. Pregnant women are 18 to 40 years; 2. 35 to 41 weeks of pregnancy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Zhongshan Bo Ai Hospital
• Investigators: Study Chair: Qian Wang, Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Estimate): February 22, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: healthy; Microbiome,; maternal and offspring; whole genome sequencing of GBS strain.; GBS test by(Q-PCR)
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: CMOH2101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No