Overweight and ObesityNCT03809390
Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children
A study testing Vaginal seeding in people with Overweight and Obesity and Allergy, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Allergy
- What is being tested?
- Vaginal seeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2018to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Liuyang Maternal and Child Health Care Hospital
Guankou, Hunan, 410399
About this study
Official title: 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.
Read the 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
- Being tested
- Vaginal seeding
- Keywords
- Body mass index, Allergic risk, Vaginal seeding, Randomized controlled study, Caesarean delivery, Overweight and obesity
- Medical subject headings
- Overweight, Obesity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal seedingProcedure or surgery
The same as that stated in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Vaginal seeding |
| Control group | No intervention | Managed based on the standard practice in the study site |
What is being measured
The primary outcome is the main question the study is designed to answer.
infant's body mass index
Body mass index in original scale and z-score
Measured: At 6 months
infant's body mass index
Body mass index in original scale and z-score
Measured: At 12 months
infant's body mass index
Body mass index in original scale and z-score
Measured: At 18 months
infant's body mass index
Body mass index in original scale and z-score
Measured: 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
Measured: At 18 months after birth
Secondary outcomes (4)
Infants' gut microbiota profile
Intestinal flora will be detected by 16sRNA sequencing using feces samples
Measured: At baseline (Meconium), 6, 12 ,18 and 24 months after birth
Rate of overweight/obesity
Defined by body mass index
Measured: At 6, 12 ,18 and 24months
Rate of allergic symptoms and common allergic diseases
Collected by using a structured questionnaire
Measured: At 61, 12 ,18 and 24 months
Rate of adverse effects
Infection-related diseases and others
Measured: From birth to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start17 Nov 2018
- Primary completion20 Sep 2021
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Liuyang Maternal and Child Health Care Hospital
- Responsible party
- Principal investigator, Jianmeng Liu, Peking University
- Investigators
- Jian-meng Liu, PhD, Study chair, Peking UniversityHong-tian Li, PhD, Principal investigator, Peking UniversityShujin Zhou, MD, Study director, Liuyang Maternal and Child Health Care HospitalYang Liu, PhD Candidate, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809390
- Sponsor's protocol ID
- NSFC.81701538
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2018
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03809390
- Acronym / sponsor ID
- NSFC.81701538
- Conditions
- Overweight and Obesity, Allergy
- Keywords
- Body mass index, Allergic risk, Vaginal seeding, Randomized controlled study, Caesarean delivery, Overweight and obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Liuyang Maternal and Child Health Care Hospital
- Study start
- 17 Nov 2018 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- Nov 2022 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal seeding group | Experimental | Procedure: Vaginal seedingSwabbing 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. |
| Control group | No intervention | –Managed based on the standard practice in the study site |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal seedingThe same as that stated in arm descriptions. | Procedure or surgery | Vaginal seeding group |
Primary outcome
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 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
4 secondary outcomes
Infants' gut microbiota profile
Time frame: At baseline (Meconium), 6, 12 ,18 and 24 months after birth
Rate of overweight/obesity
Time frame: At 6, 12 ,18 and 24months
Rate of allergic symptoms and common allergic diseases
Time frame: At 61, 12 ,18 and 24 months
Rate of adverse effects
Time frame: From birth to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: Yes. 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
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-meng Liu, PhD study chair
Peking University
Hong-tian Li, PhD principal investigator
Peking University
Shujin Zhou, MD study director
Liuyang Maternal and Child Health Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal seeding in people with Overweight and Obesity and Allergy, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infant's body mass index (time frame: At 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.