Clinical trial NCT03814395: Peking University Birth Cohort in Tongzhou
Official title: Peking University Birth Cohort in Tongzhou
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_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: 2019-01-24
Enrollment: 5426
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their children in Tongzhou, China

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women, \<14 gestational weeks
2. Resided in Tongzhou 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 Tongzhou maternal\&Child Hospital.
4. Pregnant women who is willing to participate in this study with informed consent

Exclusion Criteria:

Pregnant women have chronic disease before pregnancy, including diabetes，hypertension, liver disease and kidney disease.

Primary outcomes:
measure: Numbers of participants with pregnancy complications
timeFrame: At delivery
measure: Numbers 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, 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
measure: Height in centimeter changes during childhood
timeFrame: 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
measure: Early Child development 1
timeFrame: Age at 6 weeks and 3 years
measure: Early Child development 2
timeFrame: Age at 8-12 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: 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
measure: The proportion of children with warning signs
timeFrame: 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
measure: Fetal Biparietal Diameter
timeFrame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
measure: Fetal Head Circumference
timeFrame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
measure: Fetal Abdominal Circumference
timeFrame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
measure: Fetal Femur Length
timeFrame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
measure: Fetal Humerus Length
timeFrame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
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:
citation: 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.