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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05738473

Collaborator

Zhongshan Bo Ai Hospital (Other)

492

Enrollment

Location

16.2

Anticipated Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbiome, Human	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 Design

Study Type:

Observational

Anticipated Enrollment :

492 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 23, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Intestinal flora [The offspring are born on the 3rd 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 3rd 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 3rd day after birth]
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
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

The effect of IAP to prevent GBS-EOD. [Vaginal flora on days 3rd 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 3rd after delivery.]
Analyze the characteristics of vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.