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Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03916354
Enrollment
550
Registered
2019-04-16
Start date
2019-05-07
Completion date
2021-12-31
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Weight Gain, Microbiota, Pregnancy

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
maternal gut microbiota, vaginal microbiota, oral microbiotaFrom enrollment to 42 days postpartumThe outcome will be measured at first, second and third trimester, as well as 42 days postpartum.
gut microbiota infantsFrom delivery to 1 year postpartum.The outcome will be measured at seven specific time points after the babies delivered.

Countries

China

Contacts

Primary ContactLiangkun Ma, doctor
MaLiangKun@pumch.cn13021961166
Backup ContactYing Tian, master
1220325578@qq.com15110790115

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026