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Clinical Trials/NCT04444791
NCT04444791
Unknown
Not Applicable

Chinese Pregnant Woman Cohort Study (Offspring Follow-up)

Peking Union Medical College1 site in 1 country1,978 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Peking Union Medical College
Enrollment
1978
Locations
1
Primary Endpoint
Infants' oral development
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Peking Union Medical College
Responsible Party
Principal Investigator
Principal Investigator

Yu Jiang

School of Public Health

Peking Union Medical College

Eligibility Criteria

Inclusion Criteria

  • participated in the CPWCS and were pregnant women included in the previous cohort;
  • the baseline, first trimester, delivery outcomes, and neonatal outcomes data in the CPWCS were complete;
  • live birth and singleton in the CPWCS;
  • participate in the CPWCS-OF with child born in the CPWCS willingly;
  • able to complete the questionnaire;
  • resident in the study area;
  • signed the informed consent.

Exclusion Criteria

  • subjects not included in the CPWCS;
  • incomplete data in either of baseline, first trimester, delivery outcomes, and neonatal outcomes in the CPWCS;
  • pregnancy outcomes in the CPWCS were not singleton (abortion, stillbirth, twins, multiple births);
  • no longer resident in the study area;
  • the child has died;
  • the mother currently has mental problems and cannot cooperate well with the research.

Outcomes

Primary Outcomes

Infants' oral development

Time Frame: 2020.8.1-2020.12.1

Infants' early development

Time Frame: 2020.8.1-2020.12.1

Infants' and young children's feeding situation

Time Frame: 2020.8.1-2020.12.1

The mother will report these questions.

Infants' sleeping conditions

Time Frame: 2020.8.1-2020.12.1

Infants' defecation situation

Time Frame: 2020.8.1-2020.12.1

Mother' knowledge of infant oral health care

Time Frame: 2020.8.1-2020.12.1

Infants' physical health (asthma, allergies, autism)

Time Frame: 2020.8.1-2020.12.1

Secondary Outcomes

  • Mothers' lifestyle (smoking, sleeping)(2020.8.1-2020.12.1)
  • Mothers' anxiety condition(2020.8.1-2020.12.1)
  • Mothers' physical activity(2020.8.1-2020.12.1)
  • Mothers' dietary patterns(2020.8.1-2020.12.1)
  • Mothers' oral health(2020.8.1-2020.12.1)

Study Sites (1)

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