Chinese Pregnant Woman Cohort Study (Offspring Follow-up)

Peking Union Medical College

Status: Unknown

Conditions: Pregnancy Disease; Risk Factor; Pregnancy Related; Infant; Infant Development; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT04444791

PUMCPublicHealth

Details and patient eligibility

About

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.

Enrollment: 1,978 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,978 participants in 1 patient group

Cohort

Description:

This cohort study only set up one group. The habits and health status of mothers and their offspring will be followed up and observed. The participants will be divided into more than one group according to the variables (e.g. age, physical activity, dietary patterns, sleep quality.).