Pregnancy RelatedNCT04444791
Chinese Pregnant Woman Cohort Study (Offspring Follow-up)
An observational study of Pregnancy Related and Pregnancy Disease, run by Peking Union Medical College at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Pregnancy Disease, Pregnancy
- How many people
- 1,978 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: In the Chinese Pregnant Women Cohort Study (CPWCS), more than 9000 pregnant women were recruited from 25 July 2017 to 26 November 2018 during their routine antenatal check at the first trimester. Five hospitals of 5 different provinces in China with certain working foundation, good cooperation and high follow-up rate of pregnant women in the CPWCS were selected as study sites for the new cohort of the Chinese Pregnant Women Cohort Study-Offspring Follow-up (CPWCS-OF). From these 5 hospitals, mothers with the baseline information, first trimester questionnaire, delivery outcomes, and neonatal outcomes data completed, and had live birth and singleton were included. According to the inclusion and exclusion criteria, 1978 mothers with their infants were selected as the research objects.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Public Health, Peking Union Medical College
Beijing, Beijing Municipality, 100730
About this study
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).
Read more
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.
- Conditions
- Pregnancy Related, Pregnancy Disease, Pregnancy, Infant Development, Risk Factor, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | 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.). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants' and young children's feeding situation
The mother will report these questions.
Measured: 2020.8.1-2020.12.1
Infants' sleeping conditions
Measured: 2020.8.1-2020.12.1
Infants' defecation situation
Measured: 2020.8.1-2020.12.1
Infants' oral development
Measured: 2020.8.1-2020.12.1
Infants' early development
Measured: 2020.8.1-2020.12.1
Mother' knowledge of infant oral health care
Measured: 2020.8.1-2020.12.1
Infants' physical health (asthma, allergies, autism)
Measured: 2020.8.1-2020.12.1
Secondary outcomes (5)
Mothers' physical activity
Measured: 2020.8.1-2020.12.1
Mothers' dietary patterns
Measured: 2020.8.1-2020.12.1
Mothers' lifestyle (smoking, sleeping)
Measured: 2020.8.1-2020.12.1
Mothers' anxiety condition
Measured: 2020.8.1-2020.12.1
Mothers' oral health
Measured: 2020.8.1-2020.12.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,978 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Jiang, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444791
- Sponsor's protocol ID
- PUMCPublicHealth
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lyu T, Chen Y, Zhan Y, Shi Y, Yue H, Liu X, Meng Y, Jing A, Qu Y, Ma H, Huang P, Man D, Li X, Wu H, Zhao J, Shan G, Jiang Y. Cohort profile: the Chinese Pregnant Women Cohort Study and Offspring Follow-up (CPWCSaOF). BMJ Open. 2021 Mar 23;11(3):e044933. doi: 10.1136/bmjopen-2020-044933.
PubMed 33757952
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Pregnant Woman Cohort Study (Offspring Follow-up)
- ClinicalTrials.gov ID
- NCT04444791
- Acronym / sponsor ID
- PUMCPublicHealth
- Conditions
- Pregnancy Related, Pregnancy Disease, Pregnancy, Infant Development, Risk Factor, Infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,978 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –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.). |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In the Chinese Pregnant Women Cohort Study (CPWCS), more than 9000 pregnant women were recruited from 25 July 2017 to 26 November 2018 during their routine antenatal check at the first trimester. Five hospitals of 5 different provinces in China with certain working foundation, good cooperation and high follow-up rate of pregnant women in the CPWCS were selected as study sites for the new cohort of the Chinese Pregnant Women Cohort Study-Offspring Follow-up (CPWCS-OF). From these 5 hospitals, mothers with the baseline information, first trimester questionnaire, delivery outcomes, and neonatal outcomes data completed, and had live birth and singleton were included. According to the inclusion and exclusion criteria, 1978 mothers with their infants were selected as the research objects.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Infants' oral development
Time frame: 2020.8.1-2020.12.1
Infants' early development
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
5 secondary outcomes
Mothers' physical activity
Time frame: 2020.8.1-2020.12.1
Mothers' dietary patterns
Time frame: 2020.8.1-2020.12.1
Mothers' lifestyle (smoking, sleeping)
Time frame: 2020.8.1-2020.12.1
Mothers' anxiety condition
Time frame: 2020.8.1-2020.12.1
Mothers' oral health
Time frame: 2020.8.1-2020.12.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Derived from this study: PubMed 33757952Lyu T, Chen Y, Zhan Y, Shi Y, Yue H, Liu X, Meng Y, Jing A, Qu Y, Ma H, Huang P, Man D, Li X, Wu H, Zhao J, Shan G, Jiang Y. Cohort profile: the Chinese Pregnant Women Cohort Study and Offspring Follow-up (CPWCSaOF). BMJ Open. 2021 Mar 23;11(3):e044933. doi: 10.1136/bmjopen-2020-044933.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Pregnancy Disease, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Jian, Doctor (86+15645120652, 15645120652@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infants' and young children's feeding situation (time frame: 2020.8.1-2020.12.1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.