Pregnancy Clinical Trial
Official title:
Chinese Pregnant Woman Cohort Study (Offspring Follow-up)
Purpose: To investigate the growth and development status for children of 1 ~ 3 years old in
China, and to explore and analyze the influencing factors of infant growth. Mother's health
status would also be investigated simultaneously.
Methods and analysis: This is a multicenter prospective cohort study. Participants were all
from the Chinese Pregnant Women Cohort Study (CPWCS), which is a multicenter prospective
cohort study we conducted before. In simple terms, pregnant women during the first trimester
(5~13 weeks' gestational age) were included from 25 July 2017 to 26 November 2018. Related
information were collected by electronic self-administered questionnaire, including general
information, environmental exposure assessment, physical activity assessment, dietary and
nutritional assessment, depression assessment, sleep quality assessment and economic burden
assessment. Subsequently, objective medical information, obstetric and neonatal outcomes were
collected through hospital information system (HIS).
To further assess the mothers' and infants' health status, a new multicenter prospective
cohort study, including more than 1000 participants of the CPWCS from 5 hospitals of 5
different provinces in China, will be conducted. Through the electronic self-administered
questionnaire surveys and laboratory testing methods, information about infants' feeding,
sleeping, defecating, oral health, early development and common allergic diseases will be
collected. And we will also assess mothers' current health habits and status, such as
sleeping, diet, anxiety, physical activity, and oral health. SAS statistical software will be
used for data analysis.
Ethics and Dissemination Permission for the study was obtained from Chinese Academy of
Medical Sciences and Peking Union Medical College. Ethics approval was obtained from the
Ethics Review Committee of Department of Scientific Research, School of Basic Medicine,
Peking Union Medical College, Beijing, China. The results will be published in peer-reviewed
journals or disseminated through conference presentations.
Status | Not yet recruiting |
Enrollment | 1978 |
Est. completion date | December 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: 1. participated in the CPWCS and were pregnant women included in the previous cohort; 2. the baseline, first trimester, delivery outcomes, and neonatal outcomes data in the CPWCS were complete; 3. live birth and singleton in the CPWCS; 4. participate in the CPWCS-OF with child born in the CPWCS willingly; 5. able to complete the questionnaire; 6. resident in the study area; 7. signed the informed consent. Exclusion Criteria: 1. subjects not included in the CPWCS; 2. incomplete data in either of baseline, first trimester, delivery outcomes, and neonatal outcomes in the CPWCS; 3. pregnancy outcomes in the CPWCS were not singleton (abortion, stillbirth, twins, multiple births); 4. no longer resident in the study area; 5. the child has died; 6. the mother currently has mental problems and cannot cooperate well with the research. |
Country | Name | City | State |
---|---|---|---|
China | School of Public Health, Peking Union Medical College | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infants' and young children's feeding situation | The mother will report these questions. | 2020.8.1-2020.12.1 | |
Primary | Infants' sleeping conditions | 2020.8.1-2020.12.1 | ||
Primary | Infants' defecation situation | 2020.8.1-2020.12.1 | ||
Primary | Infants' oral development | 2020.8.1-2020.12.1 | ||
Primary | Infants' early development | 2020.8.1-2020.12.1 | ||
Primary | Mother' knowledge of infant oral health care | 2020.8.1-2020.12.1 | ||
Primary | Infants' physical health (asthma, allergies, autism) | 2020.8.1-2020.12.1 | ||
Secondary | Mothers' physical activity | 2020.8.1-2020.12.1 | ||
Secondary | Mothers' dietary patterns | 2020.8.1-2020.12.1 | ||
Secondary | Mothers' lifestyle (smoking, sleeping) | 2020.8.1-2020.12.1 | ||
Secondary | Mothers' anxiety condition | 2020.8.1-2020.12.1 | ||
Secondary | Mothers' oral health | 2020.8.1-2020.12.1 |
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