NCT03830879

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
79mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Mar 2018Dec 2032

Study Start

First participant enrolled

March 6, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Expected
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

7 years

First QC Date

January 30, 2019

Last Update Submit

February 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fetal outcomes.

    Including intrauterine growth retardation, abortion, stillbirth, live birth, preterm. birth, low birth weight, macrosomia and birth defects.

    At delivery.

Secondary Outcomes (5)

  • 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.

  • Number of participant with gestational complications.

    At delivery.

  • Number of participant with postnatal depression.

    At 30 days after delivery, 3 months, 6 months after delivery.

  • Physical development.

    at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years.

  • Neurodevelopment.

    at age of 1 month, 3 months, 6months, 1 year, 3 years and 5 years.

Study Arms (1)

No treatment

This cohort study have any no treatment.

Other: No intervention

Interventions

This cohort study have any no intervention.

No treatment

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RuiGao

Shenzhen, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Pregnancy ComplicationsDiabetes, GestationalObstetric Labor ComplicationsNeurodevelopmental DisordersPediatric Obesity

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMental DisordersObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 5, 2019

Study Start

March 6, 2018

Primary Completion

March 5, 2025

Study Completion (Estimated)

December 31, 2032

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations