Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916354
• Other study ID #: HS-1875
• Status: Recruiting
• Start date: May 7, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: Peking Union Medical College Hospital
• Contact: Liangkun Ma, doctor
• Phone: 13021961166
• Email: MaLiangKun[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Microbiota
• Pregnancy
• Weight Gain

Locations

Country	Name	City	State
China	Peking Medical Univercity College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	gut microbiota infants	The outcome will be measured at seven specific time points after the babies delivered.	From delivery to 1 year postpartum.