Skip to content

Peking University Birth Cohort in Tongzhou

Peking University Birth Cohort in Tongzhou

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03814395
Acronym
PKUBC-T
Enrollment
5426
Registered
2019-01-24
Start date
2018-06-28
Completion date
2025-08-28
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERNo intervention

This is an observational study without any intervention

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Peking University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Numbers of participants with pregnancy complicationsAt deliveryIncluding gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy
Numbers of participants with adverse pregnancy outcomesAt deliveryIncluding preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.

Secondary

MeasureTime frameDescription
Early Child development 1Age at 6 weeks and 3 yearsMeasured 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.
Early Child development 2Age at 8-12 monthsMeasured 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.
Incidence of diabetes mellitus in women6 weeks after delivery and 3 years after deliveryMeasured by health professionals in clinic
Incidence of hypertension in women6 weeks after delivery and 3 years after deliveryMeasured by health professionals in clinic
Incidence of child overweight and obesityAge 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 yearsMeasured by health professionals in clinic
Weight in kilogram changes during childhoodAt 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 yearsMeasured by health professionals in clinic
Fetal Biparietal DiameterAt 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.Measured by health professionals in clinic with ultrasound
Fetal Head CircumferenceAt 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.Measured by health professionals in clinic with ultrasound
Fetal Abdominal CircumferenceAt 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.Measured by health professionals in clinic with ultrasound
Fetal Femur LengthAt 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.Measured by health professionals in clinic with ultrasound
Fetal Humerus LengthAt 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.Measured by health professionals in clinic with ultrasound
The proportion of children with warning signsAge 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 yearsMeasured by warning signs screening
Height in centimeter changes during childhoodAt 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 yearsMeasured by health professionals in clinic

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026