Chinese Pregnant Woman Cohort Study (Offspring Follow-up)

Pregnancy Clinical Trial

Official title:

Chinese Pregnant Woman Cohort Study (Offspring Follow-up)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04444791
• Other study ID #: PUMCPublicHealth
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2020
• Source: Peking Union Medical College
• Contact: Zhao Jian, Doctor
• Phone: 86+15645120652
• Email: 15645120652[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Infant
• Infant Development
• Pregnancy
• Pregnancy Disease
• Pregnancy Related
• Risk Factor

Locations

Country	Name	City	State
China	School of Public Health, Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

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