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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06234332
Other study ID # PKUBC-WF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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