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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03809390
• Other study ID #: NSFC.81701538
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 17, 2018
• Est. completion date: November 2022

Study information

• Verified date: December 2021
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: November 2022
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity
• Overweight
• Overweight and Obesity

Intervention

Procedure:
• Vaginal seeding
The same as that stated in arm descriptions.

Locations

Country	Name	City	State
China	Liuyang Maternal and Child Health Care Hospital	Liuyang	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
Peking University	Liuyang Maternal and Child Health Care Hospital, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infant's body mass index	Body mass index in original scale and z-score	At 6 months
Primary	infant's body mass index	Body mass index in original scale and z-score	At 12 months
Primary	infant's body mass index	Body mass index in original scale and z-score	At 18 months
Primary	infant's body mass index	Body mass index in original scale and z-score	At 24 months
Primary	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	Infants' gut microbiota profile	Intestinal flora will be detected by 16sRNA sequencing using feces samples	At baseline (Meconium), 6, 12 ,18 and 24 months after birth
Secondary	Rate of overweight/obesity	Defined by body mass index	At 6, 12 ,18 and 24months
Secondary	Rate of allergic symptoms and common allergic diseases	Collected by using a structured questionnaire	At 61, 12 ,18 and 24 months
Secondary	Rate of adverse effects	Infection-related diseases and others	From birth to 24 months