NCT03916354

Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

Clinical Study of the Effect of Gestational Weight Gain on Composition of Gut Microbiome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.

Detailed description

Purpose To evaluate whether mothers' gestational weight gain is associated with differences in maternal and their infants gut microbiota characteristics. Methods and analysis This is a prospective, multicenter, observational cohort study including about 550 mother-infant pairs from PUMCH and other 3 hospitals in Beijing. After signing consent form, every participant will bring home a weighting scale for checking and record the weight every week from they enrolled to a year postpartum. The blood samples, fecal samples, vaginal swabs and oral swabs of the mothers will be collected at first, second, third trimester and postpartum 42 days. The infants' fecal samples will be collected at 0\~3, 14, 42 days and 3, 6, 9, 12 months after born. Questionnaire for mothers (diet, exercise, antibiotic and probiotic usage, oral hygiene habits etc.) and their infants (delivery mode, feeding pattern, antibiotic and probiotic usage etc.), as well as the medical records will be collected along with the sample collecting. Bio-specimen will be tested by 16S rRNA gene sequencing. Logistical regression and covariance analysis will be used to determine the relationships between the demographic data, gestational weight gain and microbiota composition.

Conditions

• Pregnancy
• Gestational Weight Gain
• Microbiota

Timeline

• Start date: 2019-05-07
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2019-04-16
• Last updated: 2020-05-21

Locations

1 site across 1 country: China