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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03809390
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital
Information provided by (Responsible Party):
Jianmeng Liu, Peking University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 : November 17, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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

Primary Outcome Measures :
  1. infant's body mass index [ Time Frame: At 6 months ]
    Body mass index in original scale and z-score

  2. infant's body mass index [ Time Frame: At 12 months ]
    Body mass index in original scale and z-score

  3. infant's body mass index [ Time Frame: At 18 months ]
    Body mass index in original scale and z-score

  4. infant's body mass index [ Time Frame: At 24 months ]
    Body mass index in original scale and z-score

  5. 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

Secondary Outcome Measures :
  1. 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

  2. Rate of overweight/obesity [ Time Frame: At 6, 12 ,18 and 24months ]
    Defined by body mass index

  3. Rate of allergic symptoms and common allergic diseases [ Time Frame: At 61, 12 ,18 and 24 months ]
    Collected by using a structured questionnaire

  4. Rate of adverse effects [ Time Frame: From birth to 24 months ]
    Infection-related diseases and others

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03809390

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Contact: Hong-tian Li, PhD 86-10-82801141
Contact: Yang Liu, PhD 86-10-18813186310

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China, Hunan
Liuyang Maternal and Child Health Care Hospital Recruiting
Liuyang, Hunan, China, 410399
Contact: Shujin Zhou, MD    86-0731-83661363   
Sponsors and Collaborators
Peking University
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital
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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

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Responsible Party: Jianmeng Liu, Professor in Perinatal Epidemiology, Peking University Identifier: NCT03809390     History of Changes
Other Study ID Numbers: NSFC.81701538
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianmeng Liu, Peking University:
Body mass index
Allergic risk
Vaginal seeding
Randomized controlled study
Caesarean delivery
Overweight and obesity
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms
Immune System Diseases