microbiota dysbiosis
Conditions
Interventions
Healthy control group:None
Case group:None
C-section Intervention Group:Vaginal Microbiota Transfer (VMT)
C-section Control Group:None
Sponsors
Foshan Maternity & Child Healthcare Hospital,
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Case-Control Study on Maternal-Infant Microecology and Fetal Malformations: 1.Case group: pregnant women clinically diagnosed with fetal malformations or with adverse pregnancy events such as preeclampsia, spontaneous abortion, and preterm birth; 2.Healthy control group: pregnant women with no structural or chromosomal abnormalities detected during routine prenatal examinations and no history of severe adverse pregnancy events; 3.Establishment of health records during the first trimester and completion of routine prenatal examinations in our hospital; 4.The pregnant women and their family members fully understand the study content and voluntarily sign the informed consent form. Randomized controlled trial of maternal vaginal microbiota transfer on gut microbiota, neurodevelopment, and allergic diseases in cesarean-delivered infants: 1. Aged 18-45 years; 2. Naturally conceived; 3. Full-term singleton pregnancy; 4. Mother-infant dyads undergoing elective cesarean section or vaginal delivery; 5. Plan to live locally for at least 1-2 years; 6. Agree to participate in this study and sign written informed consent.
Exclusion criteria
Exclusion criteria: Case-Control Study on Maternal-Infant Microecology and Fetal Malformations: 1.Multiple pregnancy; 2.Pregnant women with mental or intellectual disorders that preclude cooperation; 3.The pregnant woman or her immediate family members (grandparents, parents, spouse, siblings, children) have a history of genetic disorders; 4.Detection of sexually transmitted diseases during pregnancy (HIV, syphilis, genital herpes simplex virus, Chlamydia trachomatis, Neisseria gonorrhoeae, HPV); 5.The pregnant woman currently has malignant tumors or has a history of malignant tumors; 6.The pregnant woman has acute digestive system disorders at the time of enrollment; 7.The pregnant woman has taken microecological modulators within 2 weeks or antibiotics within 6 weeks prior to specimen collection; 8.The pregnant woman has long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin. Randomized controlled trial of maternal vaginal microbiota transfer on gut microbiota, neurodevelopment, and allergic diseases in cesarean-delivered infants: 1. Presence of severe medical diseases involving the heart, liver, kidneys, etc., or a family history of genetic or metabolic disorders; 2. Presence of severe obstetric comorbidities or complications during the current pregnancy; 3. Detection of sexually transmitted diseases during pregnancy (HIV, syphilis, genital herpes simplex virus, Chlamydia trachomatis, Neisseria gonorrhoeae, HPV); 4. Positive for group B Streptococcus (GBS) or diagnosed with vaginal infections such as trichomonal vaginitis, candidal vaginitis, or bacterial vaginosis; 5. Vaginal pH > 4.5 at admission; 6. Presence of contagious or infectious diseases; 7. Presence of severe psychiatric disorders or psychological disturbances; 8. History of taking special medications, exposure to radiation, drug abuse, or alcohol abuse during pregnancy; 9. Vaginal bleeding or premature rupture of membranes (for cesarean section only); 10. Failed trial of vaginal delivery requiring conversion to cesarean section; 11. Newborn with a 1-minute Apgar score 4000 g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of allergic rhinitis;Cord blood metabolites;Maternal blood metabolites;Umbilical cord tissue metabolites;Specific IgE;Incidence of allergic asthma;Incidence of neonatal jaundice/Incidence of hyperbilirubinemia;Amniotic fluid metabolites;Neonatal blood spot metabolites;bilirubin level;Incidence of food allergy;Infant blood metabolites;Neonatal skin microbiota and metabolites;Maternal vaginal microbiota and metabolites;Neonatal gut microbiota and metabolites;Maternal urine metabolites;total IgE;25(OH)D;Fetal membrane tissue metabolites;Maternal skin microbiota and metabolites;Incidence of atopic dermatitis;Infant Social-Emotional Development Score;Neonatal nasal microbiota and metabolites;Placental tissue metabolites;Maternal gut microbiota and metabolites;Infant Neurodevelopmental Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute eosinophil count;Maternal oral microbiota and metabolites;Severity of atopic dermatitis and quality of life level;Severity of allergic rhinitis;Safety; | — |
Countries
China
Contacts
Public ContactRihua Xie
Foshan Maternity & Child Healthcare Hospital,
Outcome results
None listed