Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03814395
Other study ID # NNSF81703240
Secondary ID 81703240
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2