Peking University Birth Cohort in Tongzhou

Obesity Clinical Trial

— PKUBC-T  

Official title:

Peking University Birth Cohort in Tongzhou

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03814395
• Other study ID #: NNSF81703240
• Secondary ID: 81703240
• Status: Active, not recruiting
• Start date: June 28, 2018
• Est. completion date: August 28, 2025

Study information

• Verified date: November 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5426
• Est. completion date: August 28, 2025
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

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 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 of participants with pregnancy complications	Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy	At delivery
Primary	Numbers 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, 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
Secondary	Height in centimeter changes during childhood	Measured by health professionals in clinic	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
Secondary	Early Child development 1	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 and 3 years
Secondary	Early Child development 2	Measured by Denver Developmental Screening Test (DDST). DDST comprises 125 test items grouped into four domains of child development: 25 personal-social (PS), 29 fine motor (FM), 39 language (LA) and 32 gross motor (GM). These test items are administered using a bell, glass bottle, set of 10 blocks, rattle, pencil, tennis ball, yarn, raisins, cup, white doll, white paper, and baby bottle. A child's raw score on each test item is marked as tested pass, failure, refusal, or no opportunity. The result of the test is labeled as "normal," "suspect" or "abnormal". Normal development means that there is no delay or at the maximum one warning. Abnormal development means that there is one or more than one delay situation. Suspicious development means that it is a situation involving one delay, one delay and one warning or two or more than two warnings. The number of children with normal, suspect or abnormal development is calculated.	Age at 8-12 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	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
Secondary	The proportion of children with warning signs	Measured by warning signs screening	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
Secondary	Fetal Biparietal Diameter	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Secondary	Fetal Head Circumference	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Secondary	Fetal Abdominal Circumference	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Secondary	Fetal Femur Length	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
Secondary	Fetal Humerus Length	Measured by health professionals in clinic with ultrasound	At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.