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

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ClinicalTrials.gov Identifier: NCT03809390
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Collaborators:
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital
Information provided by (Responsible Party):
Jianmeng Liu, Peking University

Tracking Information
First Submitted Date  ICMJE November 17, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE November 17, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • infant's body mass index [ Time Frame: At 6 months ]
    Body mass index in original scale and z-score
  • infant's body mass index [ Time Frame: At 12 months ]
    Body mass index in original scale and z-score
  • infant's body mass index [ Time Frame: At 18 months ]
    Body mass index in original scale and z-score
  • infant's body mass index [ Time Frame: At 24 months ]
    Body mass index in original scale and z-score
  • infant's allergy risk index [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Infants' gut microbiota profile [ Time Frame: 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 [ Time Frame: At 6, 12 ,18 and 24months ]
    Defined by body mass index
  • Rate of allergic symptoms and common allergic diseases [ Time Frame: At 61, 12 ,18 and 24 months ]
    Collected by using a structured questionnaire
  • Rate of adverse effects [ Time Frame: From birth to 24 months ]
    Infection-related diseases and others
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children
Official Title  ICMJE Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children: A Randomized Controlled Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight and Obesity
  • Allergy
Intervention  ICMJE Procedure: Vaginal seeding
The same as that stated in arm descriptions.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Vaginal seeding
  • No Intervention: Control group
    Managed based on the standard practice in the study site
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Hong-tian Li, PhD 86-10-82801141 liht@bjmu.edu.cn
Contact: Yang Liu, PhD 86-10-18813186310 ly180159@pku.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809390
Other Study ID Numbers  ICMJE NSFC.81701538
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianmeng Liu, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE
  • National Natural Science Foundation of China
  • Liuyang Maternal and Child Health Care Hospital
Investigators  ICMJE
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
PRS Account Peking University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP