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

NCT03809390 | Unknown

• 1 other identifier: NSFC.81701538
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Allergy

Keywords

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

Outcome Measures

Primary Outcomes (5)

• infant's body mass index

  Body mass index in original scale and z-score

  At 6 months

• infant's body mass index

  Body mass index in original scale and z-score

  At 12 months

• infant's body mass index

  Body mass index in original scale and z-score

  At 18 months

• infant's body mass index

  Body mass index in original scale and z-score

  At 24 months

• infant's allergy risk score

  Calculated based on the measurements of multiallergens with 0-6 classes,higher values represent a worse outcome which means more susceptible to allergic diseases

  At 18 months after birth

Secondary Outcomes (4)

• Infants' gut microbiota profile

  At baseline (Meconium), 6, 12 ,18 and 24 months after birth

• Rate of overweight/obesity

  At 6, 12 ,18 and 24months

• Rate of allergic symptoms and common allergic diseases

  At 61, 12 ,18 and 24 months

• Rate of adverse effects

  From birth to 24 months

Study Arms (2)

Vaginal seeding group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Managed based on the standard practice in the study site

Interventions

Vaginal seeding PROCEDURE

The same as that stated in arm descriptions.

Vaginal seeding group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead
• National Natural Science Foundation of China: collaborator
• Liuyang Maternal and Child Health Care Hospital: collaborator

Study Sites (1)

Liuyang Maternal and Child Health Care Hospital

Guankou, Hunan, 410399, China

Location

MeSH Terms

Conditions

Overweight; Obesity; Hypersensitivity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Jian-meng Liu, PhD

  Peking University

  STUDY CHAIR

• Hong-tian Li, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

• Shujin Zhou, MD

  Liuyang Maternal and Child Health Care Hospital

  STUDY DIRECTOR

• Yang Liu, PhD Candidate

  Peking University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Perinatal Epidemiology

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: January 18, 2019
• Study Start: November 17, 2018
• Primary Completion: September 20, 2021
• Study Completion: November 1, 2022
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: After the publication of the main paper (hopefully before the end of 2022), the data will be available to share to other researchers
• Access Criteria: Researchers should request the data via the following Email: lihongtian@pku.edu.cn or liujm@pku.edu.cn

Locations

CN (1)