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

NCT ID: NCT05738473

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

492 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-23

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Microbiome, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

antibiotic

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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antibiotic

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Bo Ai Hospital

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qian Wang

Role: STUDY_CHAIR

Southern Medical University, China

Locations

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Zhujiang Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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CMOH2101

Identifier Type: -

Identifier Source: org_study_id

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