Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Microbiota; Gestational Weight Gain

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 Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

• Study Contact: Name: Ying Tian, master; Phone Number: 15110790115; Email: 1220325578@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Medical Univercity College Hospital
      • Contact: Liangkun Ma; Phone Number: 13021961166 13021961166; Email: MaLiangKun@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

About 550 pregnant women meeting the conditions will be recruited from April 2019 to December 2019 during their routine antenatal caer at the first visit.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
appropriate GWG group; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: HS-1875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data put together will only be shared by PUMCH and the company, but the article signature will be decided according contribution of the sub-centers.
• IPD Sharing Time Frame: After finish the 2-year follow-up and the article of the whole data is received.
• IPD Sharing Access Criteria: Each sub-center complete their own task of enrollment and follow-up.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No