Shenzhen Birth Cohort Study

The Shenzhen Birth Cohort Study was set up to investigate the effect of early life environmental exposures on short- and long-term health consequences in Shenzhen, China.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Obstetric Labor Complications; Childhood Obesity; Neurodevelopmental Disorders; Gestational Diabetes
• Intervention / Treatment: Other: No intervention

Detailed Description

Shenzhen Birth Cohort (Xinmiao Project) is a scientific research/public health project under the support of Shenzhen city and Nanshan district, which was jointly initiated by Nanshan Maternity and Child Healthcare Hospital of Shenzhen and school of public health, Sun Yat-sen University. The project plans to recruit 10,000 participants in early pregnancy and follow up for seven years in the first stage. Biological samples, questionnaires and data for child growth and development, disease and health will be collected. The study is aimed to provide evidence for DOHaD Hypothesis and find the prevention and control measures for some childhood diseases. The core members of the research team are composed of experts from different disciplines in the field of public health, including 4 professors and 3 associate professors. With the support of an executive sponsor, the project is undertaken by the Birth Cohort Study Center. Currently, the center has 3 staff form hospital (one doctor and two masters ) and 5-7 master candidates from Sun Yat-sen University. It is an energetic and enthusiastic team.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Li Cai; Phone Number: 0086 20 87334956; Email: caili5@mail.sysu.edu.cn
• Study Contact Backup: Name: Lihua Huang; Phone Number: 0086 13570401256; Email: hlihua2@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 510000
      • Recruiting
      • RuiGao
      • Contact: Rui Gao; Phone Number: 86 13554809095; Email: ruigao@szbcs.org
      • Principal Investigator: Weiqing Chen, Professor
      • Sub-Investigator: Yuantao Hao, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending their first routine antenatal examinations and their partners and offspring.

Description

Inclusion Criteria:

• 1. Pregnant women plan to delivery and participate in child care in our hospital; 2. Pregnant women plan to reside in Shenzhen for at least 7 years; 3. Pregnant women who show interest in the study and agree to provide informed consent; 4. Gestational weeks are less than 20 weeks.Those who will agree that their neonatal will be included in the study and be followed up regularly in our child health clinic until an age of 7 years.

Exclusion Criteria:

• Pregnant women who have been pregnant for more than 20 weeks; refuse to participate; unable to guarantee delivery in our hospital or can't participate in child care in our hospital; mentally incapacitated and need guardians; or be unwilling to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment; This cohort study have any no treatment.	Other: No intervention; This cohort study have any no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal outcomes.	Including intrauterine growth retardation, abortion, stillbirth, live birth, preterm. birth, low birth weight, macrosomia and birth defects.	At delivery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal weight changes (kg).	Assess using electronic weighing machine.	At pre-pregnancy period, 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.
Number of participant with gestational complications.	Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.	At delivery.
Number of participant with postnatal depression.	Assess using Edinburgh Postnatal Depression Scale (EPDS).	At 30 days after delivery, 3 months, 6 months after delivery.
Physical development.	Including weight changes (kg) and height changes (cm).	at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years.
Neurodevelopment.	Including gross motor, fine motor, language, and social function, assess using Ages and Stages Questionnaires (ASQ-3 and ASQ-SE).	at age of 1 month, 3 months, 6months, 1 year, 3 years and 5 years.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Anticipated): March 5, 2025
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Obstetric Labor Complications; Pregnancy Complications; Neurodevelopmental Disorders; Diabetes, Gestational
• Other Study ID Numbers: SZBCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No