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

NCT ID: NCT03809390

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-17
• Study Completion Date: 2022-11-30

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.

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.

Conditions

Overweight and Obesity; Allergy

Keywords

Body mass index; Allergic risk; Vaginal seeding; Randomized controlled study; Caesarean delivery; Overweight and obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vaginal seeding

Intervention Type: PROCEDURE

The same as that stated in arm descriptions.

Control group

Managed based on the standard practice in the study site

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vaginal seeding

The same as that stated in arm descriptions.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Liuyang Maternal and Child Health Care Hospital

UNKNOWN

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jianmeng Liu

Professor in Perinatal Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-meng Liu, PhD

Role: STUDY_CHAIR

Peking University

Hong-tian Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University

Shujin Zhou, MD

Role: STUDY_DIRECTOR

Liuyang Maternal and Child Health Care Hospital

Yang Liu, PhD Candidate

Role: STUDY_DIRECTOR

Peking University

Locations

Liuyang Maternal and Child Health Care Hospital

Guankou, Hunan, China

Countries

China

Other Identifiers

NSFC.81701538

Identifier Type: -

Identifier Source: org_study_id