Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Gestational Weight Gain; Microbiota; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT03916354

HS-1875

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

550 participants in 3 patient groups

appropriate GWG group

Description:

2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is in the recommended normal range is in this group.

excess GWG group

Description:

2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is over the upper limit of the recommended normal range is in this group.

insufficient GWG group

Description:

2009 IOM criteria recommended an appropriate range of weight gain during pregnancy and during each pregnant trimester according to BMI. The participants whose GWG value is below the lower limit of the recommended normal range is in this group.