Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Gestational Weight Gain, Microbiota

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| appropriate GWG group<br>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<br>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<br>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?
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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. |