Clinical trial NCT03830879: Shenzhen Birth Cohort Study
Official title: Shenzhen Birth Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Complications
Gestational Diabetes
Obstetric Labor Complications
Neurodevelopmental Disorders
Childhood Obesity
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending their first routine antenatal examinations and their partners and offspring.

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.

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.

Primary outcomes:
measure: Fetal outcomes.
timeFrame: At delivery.
Secondary outcomes:
measure: Maternal weight changes (kg).
timeFrame: At pre-pregnancy period, 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.
measure: Number of participant with gestational complications.
timeFrame: At delivery.
measure: Number of participant with postnatal depression.
timeFrame: At 30 days after delivery, 3 months, 6 months after delivery.
measure: Physical development.
timeFrame: at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years.
measure: Neurodevelopment.
timeFrame: at age of 1 month, 3 months, 6months, 1 year, 3 years and 5 years.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: RuiGao
state: Guangdong
Study officials:
References: