Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

• Conditions: Gestational Weight Gain; Microbiota; Pregnancy

• Registration Number: NCT03916354
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-05-07
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-21
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

• Ensure a regular prenatal check in the clinical centers.
• 20-45 years old.
• 8-13 gestational weeks.
• Singleton.
• Fully understand and voluntarily sign the informed consent.

Exclusion Criteria

• IUI or IVF-ET pregnancy.
• Smoking or drinking.
• Antibiotics exposure within a month.
• With metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy.
• With digestive disease, uncontrolled thyroid disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
gut microbiota infants	From delivery to 1 year postpartum.	The outcome will be measured at seven specific time points after the babies delivered.
maternal gut microbiota, vaginal microbiota, oral microbiota	From enrollment to 42 days postpartum	The outcome will be measured at first, second and third trimester, as well as 42 days postpartum.

Trial Locations

Locations (1)

Peking Medical Univercity College Hospital; 🇨🇳 Beijing, Beijing, China