Health Problems in PregnancyPKUBC-TNCT03814395
Peking University Birth Cohort in Tongzhou
An observational study of Health Problems in Pregnancy and Pregnancy Outcomes, run by Peking University at 1 site in China.
Trial summary
The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes
- How many people
- 5,426 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2018to 28 Aug 2025
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women and their children in Tongzhou, China
Who may be able to join
- Pregnant women, <14 gestational weeks
- Resided in Tongzhou in the past half years and have no plan to move out after delivery
- Pregnant women who plan to have antenatal care and delivery in Tongzhou maternal\&Child Hospital.
- Pregnant women who is willing to participate in this study with informed consent
Who cannot join
- Pregnant women have chronic disease before pregnancy, including diabetes，hypertension, liver disease and kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.
Read the detailed description
Maternal and child health is of great concern globally. Early life phase of a fetus and infant is a critical period for the development of health and disease in the whole life. Exposure of negative environmental, nutritional and lifestyle factors in pregnant women during this period can have adverse effects on fetal and infant. In addition, for mothers, complications during pregnancy could also have a negative effect on long-term health of mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Tongzhou is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.
- Conditions
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes, Gestational Hypertension, Preterm Birth, Obesity
- Being tested
- No intervention
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Premature Birth, Obesity, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Group with environmental, nutritional or lifestyle exposures Receives: Other: No intervention | |
| Non-exposed group | Group without any environmental, nutritional and lifestyle exposures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with pregnancy complications
Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy
Measured: At delivery
Numbers of participants with adverse pregnancy outcomes
Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.
Measured: At delivery
Secondary outcomes (13)
Weight in kilogram changes during childhood
Measured by health professionals in clinic
Measured: At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Height in centimeter changes during childhood
Measured by health professionals in clinic
Measured: At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Early Child development 1
Measured by Ages\&Stages Questionnaires (ASQ).There are 6 questions in each of 5 domains of development: communication, gross motor, fine motor, problem-solving skills, and adaptive skills. Each question is given a 10 (yes), 5 (sometimes), or 0 (not yet) score according to the parents' answers. The sum scores (range from 0 to 300) and scores for each domain (range from 0 to 60) are calculated. Chinese norms are available for each domain, and any domain screened <2 SDs below the mean is considered a positive screening. A higher ASQ score means better development.
Measured: Age at 6 weeks and 3 years
Early Child development 2
Measured by Denver Developmental Screening Test (DDST). DDST comprises 125 test items grouped into four domains of child development: 25 personal-social (PS), 29 fine motor (FM), 39 language (LA) and 32 gross motor (GM). These test items are administered using a bell, glass bottle, set of 10 blocks, rattle, pencil, tennis ball, yarn, raisins, cup, white doll, white paper, and baby bottle. A child's raw score on each test item is marked as tested pass, failure, refusal, or no opportunity. The result of the test is labeled as "normal," "suspect" or "abnormal". Normal development means that there is no delay or at the maximum one warning. Abnormal development means that there is one or more than one delay situation. Suspicious development means that it is a situation involving one delay, one delay and one warning or two or more than two warnings. The number of children with normal, suspect or abnormal development is calculated.
Measured: Age at 8-12 months
Incidence of diabetes mellitus in women
Measured by health professionals in clinic
Measured: 6 weeks after delivery and 3 years after delivery
Incidence of hypertension in women
Measured by health professionals in clinic
Measured: 6 weeks after delivery and 3 years after delivery
Incidence of child overweight and obesity
Measured by health professionals in clinic
Measured: Age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
The proportion of children with warning signs
Measured by warning signs screening
Measured: Age at 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Fetal Biparietal Diameter
Measured by health professionals in clinic with ultrasound
Measured: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Head Circumference
Measured by health professionals in clinic with ultrasound
Measured: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Abdominal Circumference
Measured by health professionals in clinic with ultrasound
Measured: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Femur Length
Measured by health professionals in clinic with ultrasound
Measured: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Humerus Length
Measured by health professionals in clinic with ultrasound
Measured: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start28 Jun 2018
- Primary completion27 Aug 2019
- Study completion28 Aug 2025 (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 Health Problems in PregnancyStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- 5,426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Hai-Jun Wang, Peking University
- Investigators
- Haijun Wang, Ph.D, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814395
- Sponsor's protocol ID
- NNSF81703240
- Other IDs
- 81703240
- Acronym
- PKUBC-T
- Status last verified
- Nov 2023
- First submitted
- 16 Jan 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin C, Lin L, Han N, Zhao Z, Liu Z, Luo S, Xu X, Liu J, Wang H. Effects of dynamic change in fetuin-A levels from the first to the second trimester on insulin resistance and gestational diabetes mellitus: a nested case-control study. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e000802. doi: 10.1136/bmjdrc-2019-000802.
PubMed 31958310
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University Birth Cohort in Tongzhou
- ClinicalTrials.gov ID
- NCT03814395
- Acronym / sponsor ID
- PKUBC-T / NNSF81703240
- Conditions
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes, Gestational Hypertension, Preterm Birth, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,426 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 24 Jan 2019 (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.
The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.
Detailed description
Maternal and child health is of great concern globally. Early life phase of a fetus and infant is a critical period for the development of health and disease in the whole life. Exposure of negative environmental, nutritional and lifestyle factors in pregnant women during this period can have adverse effects on fetal and infant. In addition, for mothers, complications during pregnancy could also have a negative effect on long-term health of mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Tongzhou is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Other: No interventionGroup with environmental, nutritional or lifestyle exposures |
| Non-exposed group | – | –Group without any environmental, nutritional and lifestyle exposures |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women and their children in Tongzhou, China
Key inclusion criteria (4 listed)
- Pregnant women, <14 gestational weeks
- Resided in Tongzhou in the past half years and have no plan to move out after delivery
- Pregnant women who plan to have antenatal care and delivery in Tongzhou maternal\&Child Hospital.
- Pregnant women who is willing to participate in this study with informed consent
Key exclusion criteria (1 listed)
- Pregnant women have chronic disease before pregnancy, including diabetes，hypertension, liver disease and kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study without any intervention | Other | Exposure group |
Primary outcome
Numbers of participants with pregnancy complications
Time frame: At delivery
Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy
Numbers of participants with adverse pregnancy outcomes
Time frame: At delivery
Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.
13 secondary outcomes
Weight in kilogram changes during childhood
Time frame: At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Height in centimeter changes during childhood
Time frame: At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Early Child development 1
Time frame: Age at 6 weeks and 3 years
Early Child development 2
Time frame: Age at 8-12 months
Incidence of diabetes mellitus in women
Time frame: 6 weeks after delivery and 3 years after delivery
Incidence of hypertension in women
Time frame: 6 weeks after delivery and 3 years after delivery
Incidence of child overweight and obesity
Time frame: Age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
The proportion of children with warning signs
Time frame: Age at 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
Fetal Biparietal Diameter
Time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Head Circumference
Time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Abdominal Circumference
Time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Femur Length
Time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Fetal Humerus Length
Time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 31958310Jin C, Lin L, Han N, Zhao Z, Liu Z, Luo S, Xu X, Liu J, Wang H. Effects of dynamic change in fetuin-A levels from the first to the second trimester on insulin resistance and gestational diabetes mellitus: a nested case-control study. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e000802. doi: 10.1136/bmjdrc-2019-000802.
- Individual participant dataSharing planned: No
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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.
Haijun Wang, Ph.D principal investigator
Peking University
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 Health Problems in Pregnancy and Pregnancy Outcomes, run by Peking University 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 4 inclusion and 1 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 18 Nov 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants with pregnancy complications (time frame: At delivery). The study lists 2 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 NCT03814395, 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 18 Nov 2023.