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

December 9, 2021 updated by: Jianmeng Liu, Peking University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Liuyang, Hunan, China, 410399
        • Liuyang Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
infant's body mass index
Time Frame: At 6 months
Body mass index in original scale and z-score
At 6 months
infant's body mass index
Time Frame: At 12 months
Body mass index in original scale and z-score
At 12 months
infant's body mass index
Time Frame: At 18 months
Body mass index in original scale and z-score
At 18 months
infant's body mass index
Time Frame: At 24 months
Body mass index in original scale and z-score
At 24 months
infant's allergy risk score
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
At 18 months after birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At baseline (Meconium), 6, 12 ,18 and 24 months after birth
Rate of overweight/obesity
Time Frame: At 6, 12 ,18 and 24months
Defined by body mass index
At 6, 12 ,18 and 24months
Rate of allergic symptoms and common allergic diseases
Time Frame: At 61, 12 ,18 and 24 months
Collected by using a structured questionnaire
At 61, 12 ,18 and 24 months
Rate of adverse effects
Time Frame: From birth to 24 months
Infection-related diseases and others
From birth to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSFC.81701538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared

IPD Sharing 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

IPD Sharing Access Criteria

Researchers should request the data via the following Email: lihongtian@pku.edu.cn or liujm@pku.edu.cn

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergy

Clinical Trials on Vaginal seeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings