NCT05738473

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
492

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 22, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

January 18, 2023

Last Update Submit

February 12, 2023

Conditions

Microbiome, Human

Keywords

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

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • The effect of IAP to prevent GBS-EOD.

    Vaginal flora on days 3rd after delivery.

  • The characteristics of vaginal microbiome of pregnant women.

    Vaginal flora on days 3rd after delivery.

  • The effect of IAP to prevent GBS-EOD.

    Vaginal flora on days 42nd after delivery.

  • The characteristics of vaginal microbiome of pregnant women.

    Vaginal flora on days 42nd after delivery.

Study Arms (2)

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

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

Interventions

antibioticDRUG

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

pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Pregnant women are 18 to 40 years;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Qian Wang

    Southern Medical University, China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 22, 2023

Study Start

February 23, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 22, 2023

Record last verified: 2023-01

Locations

CN(1)