Clinical trial NCT06234332: Peking University Birth Cohort in Weifang (PKUBC-WF)
Official title: Peking University Birth Cohort in Weifang
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Health Problems in Pregnancy
Pregnancy Outcomes
Gestational Diabetes
Gestational Hypertension
Preterm Birth
Obesity
Mother-Infant Interaction
Child Development
Anemia
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-01-31
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their children in Weifang, China

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numbers and morbidity of participants with pregnancy complications
timeFrame: At delivery
measure: Numbers and morbidity of participants with adverse pregnancy outcomes
timeFrame: At delivery
Secondary outcomes:
measure: Weight in kilogram changes during childhood
timeFrame: 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
measure: Height in centimeter changes during childhood
timeFrame: 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
measure: Early Child development
timeFrame: Age at 6 weeks, 6 months and 12 months
measure: Incidence of diabetes mellitus in women
timeFrame: 6 weeks after delivery and 3 years after delivery
measure: Incidence of hypertension in women
timeFrame: 6 weeks after delivery and 3 years after delivery
measure: Incidence of child overweight and obesity
timeFrame: 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
measure: Incidence of autism spectrum disorder in children
timeFrame: Age at 2 years, 3 years
measure: Incidence of attention-deficit/hyperactivity disorder in children
timeFrame: Age at 6 years
measure: Incidence of anxiety in adolescents
timeFrame: Age at 9 years, 12 years, 15 years, and 17 years
measure: Incidence of depression in adolescents
timeFrame: Age at 9 years, 12 years, 15 years, and 17 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
affiliation: Peking University
name: Haijun Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: