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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05738473

Enrollment

492

Registered

2023-02-22

Start date

2022-02-23

Completion date

2023-06-30

Last updated

2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiome, Human

Keywords

Microbiome,, maternal and offspring, healthy, whole genome sequencing of GBS strain., GBS test by(Q-PCR)

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.

Interventions

DRUGantibiotic

For pregnant women with GBS colonization, antibiotics are used to prevent infection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026