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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
only pregnancies meet the criteria will be included in this study
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangkun Ma, doctor | Contact | 13021961166 | MaLiangKun@pumch.cn | |
| Ying Tian, master | Contact | 15110790115 | 1220325578@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Medical Univercity College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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.
After finish the 2-year follow-up and the article of the whole data is received.
Each sub-center complete their own task of enrollment and follow-up.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2019 | Apr 12, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |