Maternal Gestational Weight Gain and Microbiota of Maternal and Infant
NCT ID: NCT03916354
Last Updated: 2020-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
550 participants
OBSERVATIONAL
2019-05-07
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to 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.
No interventions assigned to 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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 20-45 years old.
* 8-13 gestational weeks.
* Singleton.
* Fully understand and voluntarily sign the informed consent.
Exclusion Criteria
* Smoking or drinking.
* Antibiotics exposure within a month.
* With metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy.
* With digestive disease, uncontrolled thyroid disease.
20 Years
45 Years
FEMALE
Yes
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Liangkun Ma
Deputy professor of obstetrics and gynecology
Locations
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Peking Medical Univercity College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HS-1875
Identifier Type: -
Identifier Source: org_study_id
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