Peking University Birth Cohort in Tongzhou

Study Overview
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Brief Summary
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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
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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.

Official Title
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Peking University Birth Cohort in Tongzhou

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

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women, <14 gestational weeks Resided in Tongzhou in the past half years and have no plan to move out after delivery Pregnant women who plan to have antenatal care and delivery in Tongzhou maternal&Child Hospital. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposure group<br>Group with environmental, nutritional or lifestyle exposures | Other: No intervention<br>* This is an observational study without any intervention<br>|
| Non-exposed group<br>Group without any environmental, nutritional and lifestyle exposures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with pregnancy complications | Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy | At delivery | 
| Numbers of participants with adverse pregnancy outcomes | Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects. | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Incidence of diabetes mellitus in women | Measured by health professionals in clinic | 6 weeks after delivery and 3 years after delivery | 
| Incidence of hypertension in women | Measured by health professionals in clinic | 6 weeks after delivery and 3 years after delivery | 
| 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 | 
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |