pregnancy probiotics preterm prevention nanopore sequencing technique adverse maternal outcomes adverse neonatal outcomes vaginal microbiomes
Conditions
Interventions
Oral probiotics supplementation starting from 12-20 weeks until 36 weeks of gestation,Placebo supplementation starting from 12-20 weeks until 36 weeks of gestation
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
oral probiotics,placebo
Sponsors
Mahidol university
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18 years and above 2. Single pregnancy 3. No serious diseases that may be associated with premature birth, such as hypertension, diabetes that requires medication, placenta previa, or other obstetric complications 4. Plan to give birth at Siriraj Hospital 5. Able to give informed consent and willing to comply with the study protocol 6. Gestational age of 12 weeks and above
Exclusion criteria
Exclusion criteria: 1. Pregnant women with indications for premature delivery, such as low placenta previa, hypertension, etc. 2. Unable to provide informed consent 3. Plan to deliver at another hospital 4. Use of antibiotics or probiotics during pregnancy 5. Multiple pregnancy 6. Vaginal or uterine infection 7. Received oral antibiotics, antifungals, antivirals or antiparasitics in the 2 months prior to sample collection 8. Received the following medications in the 6 months prior to sample collection 1) Systemic antibiotics, antifungals, antivirals or antiparasitics (both IV and IM) 2) Immunosuppressants 3) Commercial probiotics in large quantities (> 108 cfu/day) - in the form of tablets, capsules, lozenges, chewing gum or powders containing probiotics as the main ingredient (if it is a common food that is fermented, such as sour milk, yogurt, it can be eaten) 9. Unwilling to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in vaginal microbiome composition and diversity (measured by nanopore sequencing) after oral probiotic supplementation, compared to placebo, assessed at predefined time points during pregnancy. delivery type of vaginal microbiomes | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse neonatal outcomes 0-48 hours respiratory distress syndrome,Preterm birth rate delivery date gestational age at delivery,Neonatal gut microbiome composition and diversity delivery type of vaginal microbiomes | — |
Countries
Thailand
Contacts
Public ContactSaifon Chawanpaiboon
Mahidol University Faculty of Medicine Siriraj Hospital
Outcome results
None listed