Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children

Sponsor

Peking University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03809390

Collaborator

National Natural Science Foundation of China (Other), Liuyang Maternal and Child Health Care Hospital (Other)

117

Enrollment

Location

Arms

47.5

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-blind randomized controlled trial, aiming to evaluate the effects of vaginal seeding on body mass index as well as allergy risk for cesarean-delivered infants. It will be conducted in Liuyang city of China, and the targeted sample size is 106. All the eligible pregnant women will be randomly assigned to either the intervention or control group, and their babies of the participants will be followed up to 24 months of age.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Allergy	Procedure: Vaginal seeding	N/A

Detailed Description

Many studies have suggested that caesarean-delivered children are at higher risks of developing metabolic and allergic diseases like obesity and asthma, possibly because newborns born by caesarean section were lack of exposure to maternal vaginal flora. It is needed to explore a simple, convenient, and safe intervention strategy to reduce caesarean-related risks. In a recent non-randomized study, the authors found that exposure of caesarean-delivered newborns to maternal vaginal fluid at birth (i.e., vaginal seeding) could partially restore the microbiota of them at 30 days after births, but the long-term health consequences of restoring the microbiota of caesarean-delivered infants remain unclear.

In this randomized study, the investigators aim to examine whether the changes in newborns' microbiota will persist to 24 month of age, and whether vaginal seeding will have any effects on body mass index and allergy risk from birth to 24 months of age. the investigators will enroll a total of 106 pregnant women, and the participants' infants will be followed up at 0 (before hospital discharge), 6, 12, 18 and 24 months. At each follow-up visit, a questionnaire survey including information on feeding, medication, and allergic status will be conducted, infants' height and weight will be measured, and feces will be collected. At 18-month-old visit, infants' venous blood will be also collected for the assay of multiallergen. The primary outcomes were body mass index and allergy risk index. The secondary outcomes included the microbiota profile, allergic symptoms and diseases, overweight/obesity, and adverse effects.

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children: A Randomized Controlled Study

Actual Study Start Date :

Nov 17, 2018

Actual Primary Completion Date :

Sep 20, 2021

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal seeding group Swabbing infants born by C-section with a gauze incubated in the maternal vagina about an hour before the C-section. The gauze will be extracted prior to the C-section, kept in a sterile container in an incubator (37 ℃), and taken out from the incubator immediately before the swabbing. The infant will be swabbed with the gauze, starting from the lips, followed by the face, thorax, arms, legs, genitals and anal region, and finally the back. The swabbing will take around 15-20 seconds.	Procedure: Vaginal seeding The same as that stated in arm descriptions.
No Intervention: Control group Managed based on the standard practice in the study site

Arm

Intervention/Treatment

Experimental: Vaginal seeding group

Swabbing infants born by C-section with a gauze incubated in the maternal vagina about an hour before the C-section. The gauze will be extracted prior to the C-section, kept in a sterile container in an incubator (37 ℃), and taken out from the incubator immediately before the swabbing. The infant will be swabbed with the gauze, starting from the lips, followed by the face, thorax, arms, legs, genitals and anal region, and finally the back. The swabbing will take around 15-20 seconds.

Procedure: Vaginal seeding

The same as that stated in arm descriptions.

No Intervention: Control group

Managed based on the standard practice in the study site

Outcome Measures

Primary Outcome Measures

infant's body mass index [At 6 months]
Body mass index in original scale and z-score
infant's body mass index [At 12 months]
Body mass index in original scale and z-score
infant's body mass index [At 18 months]
Body mass index in original scale and z-score
infant's body mass index [At 24 months]
Body mass index in original scale and z-score
infant's allergy risk score [At 18 months after birth]
Calculated based on the measurements of multiallergens with 0-6 classes,higher values represent a worse outcome which means more susceptible to allergic diseases

Secondary Outcome Measures

Infants' gut microbiota profile [At baseline (Meconium), 6, 12 ,18 and 24 months after birth]
Intestinal flora will be detected by 16sRNA sequencing using feces samples
Rate of overweight/obesity [At 6, 12 ,18 and 24months]
Defined by body mass index
Rate of allergic symptoms and common allergic diseases [At 61, 12 ,18 and 24 months]
Collected by using a structured questionnaire
Rate of adverse effects [From birth to 24 months]
Infection-related diseases and others

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

local resident in Liuyang city
Singleton, term pregnancy (≥37 weeks of gestation)
Cesarean section before labor starts without maternal complications, or cesarean section after the start of labor but the cervix is less than 3 cm
Vaginal pH< 4.5 at enrollment

Exclusion Criteria:

Positive testing for HIV, HBV, syphilis or GBS infection at gestation
Vaginal infections such as genital herpetic lesions or chlamydia
Bacterial vaginosis
Trichomonas or fungous in leucorrhea
Pregnant women or her spouse with severe allergic diseases, such as asthma and severe drug allergy
Vaginal pH ≥4.5 at 1-2 hours before the cesarean section
Other conditions not suitable for intervention as judged by obstetricians

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liuyang Maternal and Child Health Care Hospital	Liuyang	Hunan	China	410399

Sponsors and Collaborators

Peking University
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital

Investigators

Study Chair: Jian-meng Liu, PhD, Peking University
Principal Investigator: Hong-tian Li, PhD, Peking University
Study Director: Shujin Zhou, MD, Liuyang Maternal and Child Health Care Hospital
Study Director: Yang Liu, PhD Candidate, Peking University