Shenzhen Birth Cohort Study

Gestational Diabetes Clinical Trial

Official title:

Shenzhen Birth Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03830879
• Other study ID #: SZBCS
• Status: Recruiting
• Start date: March 6, 2018
• Est. completion date: December 31, 2032

Study information

• Verified date: February 2019
• Source: Sun Yat-sen University
• Contact: Li Cai
• Phone: 0086 20 87334956
• Email: caili5[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2032
• Est. primary completion date: March 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Diabetes, Gestational
• Gestational Diabetes
• Neurodevelopmental Disorders
• Obstetric Labor Complications
• Pediatric Obesity
• Pregnancy Complications

Intervention

Other:
• No intervention
This cohort study have any no intervention.

Locations

Country	Name	City	State
China	RuiGao	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal outcomes.	Including intrauterine growth retardation, abortion, stillbirth, live birth, preterm. birth, low birth weight, macrosomia and birth defects.	At delivery.
Secondary	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.
Secondary	Number of participant with gestational complications.	Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.	At delivery.
Secondary	Number of participant with postnatal depression.	Assess using Edinburgh Postnatal Depression Scale (EPDS).	At 30 days after delivery, 3 months, 6 months after delivery.
Secondary	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.
Secondary	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.