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Maternal vaginal microbiota transfer restores the early gut microbiome in caesarean-born infants: a randomized controlled trial

The effect of maternal vaginal microbiota transfer on the gut microbiome and health outcomes in caesarean-born infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031326
Enrollment
Unknown
Registered
2020-03-27
Start date
2020-12-10
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic diseases in cesarean-born infants

Interventions

CS(cesarean section) Intervation group:swabbed with vaginal fluids guaze
CS(cesarean section) Control group:swabbed with sterile saline guaze
VD(vaginal delivery) group:None

Sponsors

The Seventh Affiliated Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women with a live, singleton at 37 and 42 weeks gestation; 2. Women aged 18-45 years; 3. Neonate with an Apgar scores > 7 and a birth weight of 2500-4000 grams; 4. Plan to reside in Nanhai district for more than twelve months; 5. Agree to participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. With bloody show and or premature rupture of membranes; 2. With a history of drug abuse or alcoholism; 3. With pre-pregnancy autoimmune diseases, or a history of serious medical illneses such as heart, liver and kidney, etc.; 4. With infectious diseases (e.g., chorioamnionitis, urinary tract infection, or colonization with multidrug-resistant bacteria); 5. With severe obstetric complications during this pregnancy (e.g., pre-eclampsia, placenta previa, placental abruption, etc) 6. With sexually transmitted diseases (e.g.,HIV, syphilis, gonorrhea, etc); 7. With vaginitis (e.g., bacterial vaginosis, trichomoniasis, candida vaginitis, etc); 8. Infection with Group B Streptococcus, herpes simplex viruses, human papillomavirus, Chlamydia trachomatis, etc.; 9. Use of assisted reproductive technology; 10. Failed vaginal delivery attempt converted to caesarean section; 11. With a history of serious mental or psychological disorders; 12. Newborn with birth defects, or suffering intrauterine infection, hypoxic-ischemic encephalopathy, intracranial hemorrhage, necrotizing enterocolitis, etc.

Design outcomes

Primary

MeasureTime frame
Neurodevelopment/cogitive development;Neurodevelopment/cognitive;

Secondary

MeasureTime frame
safety;gut bacterial microbiome;gut fungal microbiome;gut metabolome;growth and development;social-emotional development;atopic dermatitis;allergic asthma;allergic rhinitis;food allergy;

Countries

China

Contacts

Public ContactRihua Xie

The Seventh Affiliated Hospital, Southern Medical University

xierihua928@163.com+86 189 2869 7126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 25, 2026