Status:
UNKNOWN
Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children
Lead Sponsor:
Peking University
Collaborating Sponsors:
National Natural Science Foundation of China
Liuyang Maternal and Child Health Care Hospital
Conditions:
Overweight and Obesity
Allergy
Eligibility:
FEMALE
Phase:
NA
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...
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 sec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT03809390
Start Date
November 17 2018
End Date
November 1 2022
Last Update
December 10 2021
Active Locations (1)
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1
Liuyang Maternal and Child Health Care Hospital
Guankou, Hunan, China, 410399