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Abstract
ACTIVATE is a pilot study that will investigate how differences in the microbiome of a baby may protect, or put them at risk, for allergies. The study will measure whether wiping babies born by C-section with their mother’s vaginal fluids (which contains potentially beneficial bacteria; referred to as “vaginal seeding”) right after birth will lower the risk of developing positive allergy tests at one year of age.
ACTIVATE will enroll 120 pregnant women and their babies who are at higher-risk for developing allergies. This will include:
- 80 women who are planning a C-section delivery who will be randomized 1:1 to have their newborns undergo vaginal seeding with vaginal microbiota or placebo seeding within 5 minutes after birth
- 40 women who are planning a vaginal delivery
Vaginal seeding has not been approved by the FDA and, therefore, is considered an experimental procedure in this study. As part of this study we will be assessing the safety of vaginal seeding, as well as whether it can help protect babies from developing egg, milk, and peanut allergies at 12 months of age.
About This Study
The ACTIVATE study will investigate how differences in the microbiome of a baby may protect, or put them at risk, for allergies. To do this, the study will measure whether wiping babies born by C-section with their mother’s vaginal fluids (which contains potentially beneficial bacteria; referred to as “vaginal seeding”) right after birth will lower the risk of developing positive allergy tests at one year of age.
ACTIVATE will enroll 120 pregnant women and their babies who are at higher-risk for developing allergies. This will include:
- 80 women who are planning a C-section delivery
- 40 women who are planning a vaginal delivery
Vaginal Seeding
The transfer of vaginal fluids to C-section babies immediately after birth is referred to as “vaginal seeding.” Some mothers with babies born by C-section request this procedure, however, whether vaginal seeding is helpful or could harm your baby is uncertain. Because of this, the American College of Obstetricians and Gynecologists recommends against doing vaginal seeding until more is known.
Vaginal seeding has not been approved by the FDA and, therefore, is considered an experimental procedure in this study. As part of this study we will be assessing the safety of vaginal seeding, as well as whether it can help protect your baby from allergic problems. It is currently uncertain whether vaginal seeding could help or harm your baby.
The ACTIVATE study is an important step in understanding the effects of vaginal seeding, particularly for families with a history of allergy.
Participating in ACTIVATE
For C-section Mothers
Half of the women planning a C-section delivery will be randomly assigned to have their babies receive vaginal seeding. The other half of the C-section women’s babies will receive “placebo” vaginal seeding, where the baby will be wiped with a clean, moist gauze that does not contain vaginal fluids.
Prior to delivery, a moist gauze will be placed inside the vagina to collect vaginal fluids. Immediately after birth, the unblinded nurse/physician assistant will wipe the baby with the gauze that contains vaginal fluid or just a wet gauze, depending on the assigned study group.
For Vaginal Delivery Mothers
The women planning vaginal deliveries will undergo delivery as normal.
All Mothers
Following delivery, all babies in ACTIVATE will be followed for the first year of life. Babies will be tested to six common allergens (egg, milk, peanut, house dust mite, cat, and cockroach) when they are one year of age.
The newborn baby’s microbiome changes very quickly during the first weeks and months of life. Parents will collect samples at home and complete questionnaires that will be used for research tests to understand the development of the baby’s microbiome.