Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

NCT03916354 | Unknown

• 1 other identifier: HS-1875
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Gestational Weight Gain; Microbiota

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

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.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: only pregnancies meet the criteria will be included in this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Medical Univercity College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liangkun Ma, doctor

CONTACT

13021961166; MaLiangKun@pumch.cn

Ying Tian, master

CONTACT

15110790115; 1220325578@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy professor of obstetrics and gynecology

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: May 7, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After finish the 2-year follow-up and the article of the whole data is received.
• Access Criteria: Each sub-center complete their own task of enrollment and follow-up.

Locations

CN (1)