Shenzhen Birth Cohort Study

Recruiting

• Conditions: Gestational Diabetes; Obstetric Labor Complications; Neurodevelopmental Disorders; Pregnancy Complications; Childhood Obesity
• Interventions: Other: No intervention

• Registration Number: NCT03830879
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2019-01-30
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Study First Posted: 2019-02-05
• Last Update Posted: 2019-02-05
• Primary Completion: 2025-03-05
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	No intervention	This cohort study have any no treatment.

Primary Outcome Measures

Name	Time	Method
Fetal outcomes.	At delivery.	Including intrauterine growth retardation, abortion, stillbirth, live birth, preterm. birth, low birth weight, macrosomia and birth defects.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

RuiGao; 🇨🇳 Shenzhen, Guangdong, China