Effects of IAP-EOGBSD on Maternal Vaginal Microbiome, Offspring's Gut Microbiome and Metabolites. (NCT05738473) | Clinical Trial Compass
UnknownNot Applicable
Effects of IAP-EOGBSD on Maternal Vaginal Microbiome, Offspring's Gut Microbiome and Metabolites.
China492 participantsStarted 2022-02-23
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intestinal flora
Timeframe: The offspring are born on the 3rd day after birth
2
Secretory IgA
Timeframe: The offspring are born on the 3rd day after birth
3
Calprotectin
Timeframe: The offspring are born on the 3rd day after birth
4
Intestinal flora
Timeframe: The offspring are born on the 42nd day after birth
5
Secretory IgA
Timeframe: The offspring are born on the 42nd day after birth
6
Calprotectin
Timeframe: The offspring are born on the 42nd day after birth