Clinical trial NCT05738473: Effects of IAP-EOGBSD on Maternal Vaginal Microbiome, Offspring's Gut Microbiome and Metabolites.
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiome, Human
Keywords: Microbiome,
maternal and offspring
healthy
whole genome sequencing of GBS strain.
GBS test by(Q-PCR)
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Zhongshan Bo Ai Hospital
First posted: 2023-02-22
Enrollment: 492
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Pregnant women are 18 to 40 years; 2. 35 to 41 weeks of pregnancy

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intestinal flora
timeFrame: The offspring are born on the 3rd day after birth
measure: Secretory IgA
timeFrame: The offspring are born on the 3rd day after birth
measure: Calprotectin
timeFrame: The offspring are born on the 3rd day after birth
measure: Intestinal flora
timeFrame: The offspring are born on the 42nd day after birth
measure: Secretory IgA
timeFrame: The offspring are born on the 42nd day after birth
measure: Calprotectin
timeFrame: The offspring are born on the 42nd day after birth
Secondary outcomes:
measure: The effect of IAP to prevent GBS-EOD.
timeFrame: Vaginal flora on days 3rd after delivery.
measure: The characteristics of vaginal microbiome of pregnant women.
timeFrame: Vaginal flora on days 3rd after delivery.
measure: The effect of IAP to prevent GBS-EOD.
timeFrame: Vaginal flora on days 42nd after delivery.
measure: The characteristics of vaginal microbiome of pregnant women.
timeFrame: Vaginal flora on days 42nd after delivery.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guang Dong
Study officials:
affiliation: Southern Medical University, China
name: Qian Wang
role: STUDY_CHAIR
References: