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

Z

Zhujiang Hospital

Status

Active, not recruiting

Conditions

Microbiome, Human

Treatments

Drug: antibiotic

Study type

Observational

Funder types

Other

Identifiers

NCT05738473
CMOH2101

Details and patient eligibility

About

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.

Full 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.

Enrollment

492 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

492 participants in 2 patient groups

pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP
Description:
vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS)、Pregnant women undergoing IAP
Treatment:
Drug: antibiotic
pregnant women does not colonized by Group B Streptococcus (GBS) and not undergoing IAP
Description:
Group B streptococcus (GBS) does not colonize the vaginal microbiome of pregnant women、Pregnant wome

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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