Health Problems in PregnancyNCT06234332
Peking University Birth Cohort in Weifang (PKUBC-WF)
An observational study of Health Problems in Pregnancy and Pregnancy Outcomes, run by Peking University at 1 site in China.
Trial summary
The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes
- How many people
- 2,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women and their children in Weifang, China
Who may be able to join
- Pregnant woman
- Pregnant women, 6-13^+6 gestational weeks
- Resided in Weifang 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 Weifang maternal\&Child Hospital.
- Pregnant women who is willing to participate in this study with informed consent
- Pregnant woman's husband
Show all 11Show fewer
- His wife was eligible for enrollment
- He is the biological father of the child (his wife's current pregnancy)
- Pregnant women's husband who is willing to participate in this study with informed consent
- Offspring 4. Children born to pregnant women who met the inclusion criteria after enrolling in this study.
- 5. Before the age of 8 years, his/her mother provided written informed consent. 6. After 8 years old, he/she agreed to continue this study and signed the informed consent.
Who cannot join
- Participants who cannot communicate normally.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University
Beijing, Beijing Municipality, 100191
Haijun Wang, Ph.D, 86-010-82805583, whjun1@bjmu.edu.cn
Jue Liu, Ph.D, 86-13426455743, jueliu@bjmu.edu.cn
About this study
Official title: Peking University Birth Cohort in Weifang
The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, 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 before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.
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 Weifang 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, husbands and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces samples are also collected.
- Conditions
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes, Gestational Hypertension, Preterm Birth, Obesity
- Being tested
- No Interventions
- 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 InterventionsOther
No intervention 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 Interventions | |
| 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 and morbidity of participants with pregnancy complications
Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy
Measured: At delivery
Numbers and morbidity of participants with adverse pregnancy outcomes
Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.
Measured: At delivery
Secondary outcomes (10)
Weight in kilogram changes during childhood
Measured by health professionals in clinic
Measured: At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Height in centimeter changes during childhood
Measured by health professionals in clinic
Measured: At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Early Child development
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, 6 months and 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: At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Incidence of autism spectrum disorder in children
Measured by The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F) and Autism Behavior Checklist (ABC) scales
Measured: Age at 2 years, 3 years
Incidence of attention-deficit/hyperactivity disorder in children
Measured by The Child Behavior Checklist (CBC) scale
Measured: Age at 6 years
Incidence of anxiety in adolescents
Measured by Social Anxiety Scale for Adolescents (SAS-A) scale
Measured: Age at 9 years, 12 years, 15 years, and 17 years
Incidence of depression in adolescents
Measured by Beck Depression Inventory-II (BDI-II) scale
Measured: Age at 9 years, 12 years, 15 years, and 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,800 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
- NCT06234332
- Sponsor's protocol ID
- PKUBC-WF
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University Birth Cohort in Weifang
- ClinicalTrials.gov ID
- NCT06234332
- Acronym / sponsor ID
- PKUBC-WF
- Conditions
- Health Problems in Pregnancy, Pregnancy Outcomes, Gestational Diabetes, Gestational Hypertension, Preterm Birth, Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2043 (estimated)
- First posted
- 31 Jan 2024 (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-WF is a prospective cohort study carried out in Weifang city of Shandong, 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 before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.
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 Weifang 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, husbands and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces samples are also collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Other: No InterventionsGroup with environmental, nutritional or lifestyle exposures |
| Non-exposed group | – | –Group without any environmental, nutritional and lifestyle exposures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women and their children in Weifang, China
Key inclusion criteria (11 listed)
- Pregnant woman
- Pregnant woman's husband
- Offspring 4. Children born to pregnant women who met the inclusion criteria after enrolling in this study.
- 5. Before the age of 8 years, his/her mother provided written informed consent. 6. After 8 years old, he/she agreed to continue this study and signed the informed consent.
Key exclusion criteria (1 listed)
- Participants who cannot communicate normally.
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 InterventionsNo intervention This is an observational study without any intervention | Other | Exposure group |
Primary outcome
Numbers and morbidity of participants with pregnancy complications
Time frame: At delivery
Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy
Numbers and morbidity of participants with adverse pregnancy outcomes
Time frame: At delivery
Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.
10 secondary outcomes
Weight in kilogram changes during childhood
Time frame: At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Height in centimeter changes during childhood
Time frame: At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Early Child development
Time frame: Age at 6 weeks, 6 months and 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: At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years
Incidence of autism spectrum disorder in children
Time frame: Age at 2 years, 3 years
Incidence of attention-deficit/hyperactivity disorder in children
Time frame: Age at 6 years
Incidence of anxiety in adolescents
Time frame: Age at 9 years, 12 years, 15 years, and 17 years
Incidence of depression in adolescents
Time frame: Age at 9 years, 12 years, 15 years, and 17 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- 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.
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 11 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haijun Wang, Ph.D (86-010-82805583, whjun1@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers and morbidity 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?
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 Nov 2025.