Shenzhen Birth Cohort Study | NCT03830879

Studies
Shenzhen Birth Cohort Study

NCT03830879

Sponsor

Sun Yat-sen University

Status

Recruiting

Last Update Posted

Feb 5, 2019Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Pregnancy Complications
Gestational Diabetes
Obstetric Labor Complications
Neurodevelopmental Disorders
Childhood Obesity

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2018Actual

Primary Completion Date

Mar 5, 2025Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Feb 1, 2019

First Posted Date

Feb 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No treatment		This cohort study have any no treatment.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	This cohort study have any no intervention.	No treatment

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

49 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li Cai	Contact	0086 20 87334956		caili5@mail.sysu.edu.cn
Lihua Huang	Contact	0086 13570401256		hlihua2@mail2.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RuiGao	Recruiting	Shenzhen	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications
D016640	Diabetes, Gestational
D007744	Obstetric Labor Complications
D065886	Neurodevelopmental Disorders
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Description

During pregnancy: maternal blood, urine, hair and toenails. At delivery: umbilical cord blood, placenta , umbilical cord, meconium, mother's saliva and milk. During infancy: dry blood spot, stool and blood. During childhood: Mother's saliva, milk, baby's saliva and feces.