Peking University Birth Cohort in Weifang (PKUBC-WF)

Obesity Clinical Trial

Official title:

Peking University Birth Cohort in Weifang

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234332
• Other study ID #: PKUBC-WF
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2043

Study information

• Verified date: January 2024
• Source: Peking University
• Contact: Haijun Wang, Ph.D
• Phone: 86-010-82805583
• Email: whjun1[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2800
• Est. completion date: December 31, 2043
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant woman

1. Pregnant women, 6-13^+6 gestational weeks

2. Resided in Weifang in the past half years and have no plan to move out after delivery

3. Pregnant women who plan to have antenatal care and delivery in Weifang maternal&Child Hospital.

4. Pregnant women who is willing to participate in this study with informed consent

• Pregnant woman's husband

1. His wife was eligible for enrollment

2. He is the biological father of the child (his wife's current pregnancy)

3. 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.

Exclusion Criteria:

• Participants who cannot communicate normally.

Related Conditions & MeSH terms

• Anemia
• Child Development
• Diabetes, Gestational
• Gestational Diabetes
• Gestational Hypertension
• Health Problems in Pregnancy
• Hypertension, Pregnancy-Induced
• Mother-Infant Interaction
• Obesity
• Pregnancy Outcomes
• Premature Birth
• Preterm Birth

Intervention

Other:
• No Interventions
No intervention This is an observational study without any intervention

Locations

Country	Name	City	State
China	Peking University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers and morbidity of participants with pregnancy complications	Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy	At delivery
Primary	Numbers and morbidity of participants with adverse pregnancy outcomes	Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.	At delivery
Secondary	Weight in kilogram changes during childhood	Measured by health professionals in clinic	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
Secondary	Height in centimeter changes during childhood	Measured by health professionals in clinic	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
Secondary	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.	Age at 6 weeks, 6 months and 12 months
Secondary	Incidence of diabetes mellitus in women	Measured by health professionals in clinic	6 weeks after delivery and 3 years after delivery
Secondary	Incidence of hypertension in women	Measured by health professionals in clinic	6 weeks after delivery and 3 years after delivery
Secondary	Incidence of child overweight and obesity	Measured by health professionals in clinic	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
Secondary	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	Age at 2 years, 3 years
Secondary	Incidence of attention-deficit/hyperactivity disorder in children	Measured by The Child Behavior Checklist (CBC) scale	Age at 6 years
Secondary	Incidence of anxiety in adolescents	Measured by Social Anxiety Scale for Adolescents (SAS-A) scale	Age at 9 years, 12 years, 15 years, and 17 years
Secondary	Incidence of depression in adolescents	Measured by Beck Depression Inventory-II (BDI-II) scale	Age at 9 years, 12 years, 15 years, and 17 years