Chinese Pregnant Woman Cohort Study (Offspring Follow-up)

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

• Registration Number: NCT04444791
• Lead Sponsor: Peking Union Medical College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Last Update Submitted: 2020-06-20
• Study First Posted: 2020-06-24
• Last Update Posted: 2020-06-24
• Study Start: 2020-08-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1978

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infants' oral development	2020.8.1-2020.12.1
Infants' early development	2020.8.1-2020.12.1
Infants' and young children's feeding situation	2020.8.1-2020.12.1	The mother will report these questions.
Infants' sleeping conditions	2020.8.1-2020.12.1
Infants' defecation situation	2020.8.1-2020.12.1
Mother' knowledge of infant oral health care	2020.8.1-2020.12.1
Infants' physical health (asthma, allergies, autism)	2020.8.1-2020.12.1

Secondary Outcome Measures

Name	Time	Method
Mothers' anxiety condition	2020.8.1-2020.12.1
Mothers' lifestyle (smoking, sleeping)	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

Trial Locations

Locations (1)

School of Public Health, Peking Union Medical College; 🇨🇳 Beijing, Beijing, China