Vaginal Microbiome Exposure and Immune Responses in C-section Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2027-01-31

Brief Summary

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The purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems. The microbiome refers to the thousands of bacteria and molds that live in and on our bodies. The microbiome plays an important role in our health. Differences in the microbiome can affect our immune system in ways that might make some people more likely to get allergies and asthma.

Early life events and exposures are very important for establishing the human microbiome. The newborn baby's microbiome changes very quickly during the first weeks and months of life. There is information that suggests C-section birth is associated with higher risk of certain diseases, including allergies and asthma. Some researchers think one reason for this is that passing through the mother's vaginal canal during birth exposes the baby to bacteria that promote healthy immune system development, something that C-section babies don't get. Transferring these potentially beneficial vaginal bacteria to C-section babies may help prevent some diseases later.

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Detailed Description

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This is a pilot study of 120 pregnant women and their infants conducted at hospitals in the Mount Sinai Health System in New York, NY. Eighty women will deliver via elective, unlabored C-section, and 40 will undergo spontaneous vaginal delivery. The 80 women undergoing C-section will be randomized in a masked (blinded) 1:1 fashion to have their neonates undergo vaginal seeding or placebo seeding immediately after birth (within 10 minutes) followed by standard care.The infants of the 40 women undergoing spontaneous vaginal delivery will receive usual standard care.

All 120 pregnant women will have biospecimens collected to assess their vaginal, skin, gut, placental, breast milk, and oral microbiome. All infants will have biospecimens collected to assess their gut, skin, nasal, and oral microbiome, as well as blood to assess allergen sensitization and immune markers. Infants will be followed with at-home stool collections and questionnaires weekly for the first 4 weeks and at weeks 8, 26, and 39. An in-person study visit will occur at 13 weeks and 52 weeks, and the primary endpoint will be assessed at 52 weeks. Study enrollment is projected to occur over 24 months.

Conditions

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Allergic Diseases Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will enroll pregnant women during the third trimester of pregnancy whose infants have a first-degree relative ( the mother, biological father, or full sibling) with atopic disease or food allergy.The study excludes women with a history of active atopic dermatitis within the past 5 years to avoid the potential transfer of vaginal microbiota to the infant that may predispose to atopic disease.Women undergoing elective, unlabored C-section will be randomized to have their infants undergo vaginal seeding or placebo seeding plus standard of care. Women and infants who undergo placebo seeding will serve as a control population.In addition, women and infants undergoing vaginal delivery will also be included as a second control group, in part to determine if vaginal seeding will decrease allergen sensitization rates to a level similar to vaginally delivered infants, and also to serve as a comparator group for gut microbiome development during the infant's first year of life.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

With the exception of the study nurse performing the vaginal seeding procedure, all study participants and study personnel will be masked (blinded) to the infant's randomization status.

Study Groups

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C-section -Vaginal seeding

Pregnant women who undergo C-section and (neonate) vaginal seeding.

Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with gauze containing their mother's vaginal microbiota just after delivery.

Group Type EXPERIMENTAL

Vaginal seeding

Intervention Type DRUG

Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.

Standard care

Intervention Type OTHER

Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery

Post-seeding Care

Intervention Type OTHER

Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery.

C-section - Placebo Seeding

Pregnant women who undergo C-section and (neonate) placebo seeding.

Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with sterile gauze (placebo).

Group Type EXPERIMENTAL

Placebo Seeding

Intervention Type DRUG

Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.

Standard care

Intervention Type OTHER

Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery

Post-seeding Care

Intervention Type OTHER

Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery.

Vaginal Delivery

Pregnant women who undergo spontaneous vaginal delivery (of neonate).

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery

Interventions

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Vaginal seeding

Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.

Intervention Type DRUG

Placebo Seeding

Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.

Intervention Type DRUG

Standard care

Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery

Intervention Type OTHER

Post-seeding Care

Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery.

Intervention Type OTHER

Other Intervention Names

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vaginal microbiota maternal vaginal microbiota placebo microbiota placebo vaginal microbiota standard of care

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman must be able to understand and provide informed consent;
* Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus; and

Exclusion Criteria

For C-Section Mothers:

* In labor with evidence of cervical change prior to the scheduled C-section;
* Rupture of the amniotic sac; or
* Vaginal pH \> 4.5 on the day of delivery.

For Vaginal Delivery Mothers:

\- Use of induction agents for cervical ripening (cervical prostaglandin or Foley catheter).

For All Mothers and Their Infants:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
* History of moderate to severe atopic dermatitis within the past year in the mother;
* Express no intention to breastfeed;
* History of diabetes mellitus or gestational diabetes mellitus;
* History of inflammatory bowel disease (IBD) (e.g., Crohn's Disease or ulcerative colitis);
* Evidence of an active sexually transmitted infection (STI) (e.g., primary herpes or genital warts, or trichomonas), yeast infection, or vaginosis on the day of delivery;
* Evidence of prior or current hepatitis B or C infection as demonstrated by the presence of the hepatitis B surface antigen, antibody positivity against the hepatitis B core antigen, or antibody positivity against the hepatitis C virus;

--Assessment for active hepatitis B and hepatitis C infection will be repeated for this study even if prior testing during the current pregnancy was negative;
* Evidence of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV serology or detectable viral load);
* Positive Group B Streptococcus (GBS) test results by rectovaginal swab performed within 5 weeks of delivery, a prior infant with invasive GBS disease, or GBS bacteriuria at any point during pregnancy;
* Evidence of N. gonorrhoeae or C. trachomatis infection by testing performed within 5 weeks of delivery;
* History of antibiotic administration during the third trimester of the current pregnancy;
* Mothers with serious chronic conditions during pregnancy;
* Mothers with complicated pregnancies including pre-eclampsia, chorioamnionitis, placenta previa, vasa previa, placental abruption, or active vaginal bleeding;
* Maternal fever on the day of delivery (visit 0);
* Infants with complications during delivery, such that the infant requires more than the standard neonatal resuscitation after delivery;
* Infants delivered prior to 37 weeks of gestation;
* Thick particulate meconium noted upon delivery of the infant;
* Presence of a congenital abnormality in the infant for which study participation is not recommended;
* Current, diagnosed mental illness or current, diagnosed or self-reported drug or alcohol abuse in the mother that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
* Use of investigational drugs during the third trimester of pregnancy; or
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator may:

* Pose additional risks from participation in the study,
* Interfere with the participant's ability to comply with study requirements, or
* May impact the quality or interpretation of the data obtained from the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No