No-worry Baby Project

Obesity Clinical Trial

Official title:

Huizhou Mother-infant Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922087
• Other study ID #: HZT2018
• Status: Completed
• Start date: November 20, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Huizhou mother-infant cohort was set up to investigate the effect of dietary factors and environmental exposures during pregnancy on health consequences of mothers and offsprings in Huizhou, China.

Description:

Huizhou mother-infant cohort (No-worry Baby Project) is a scientific research/public health project jointly initiated by Huizhou First Maternity and Child Healthcare Hospital and School of Public Health, Sun Yat-sen University. The project plans to recruit 10,000 participants since early pregnancy and follow up for three years after birth in the first stage. Biological samples, data from questionnaires survey and clinical information will be collected for both mothers and infants. The study is aimed to investigate the effects of dietary factors and environmental exposures during pregnancy on infants' health as well as the prognosis of diseased mothers. The study will have essentially both clinical and public health implications to find effective strategies for prevention and management of a range of chronic disorders (above mentioned) during pregnancy and exploration of the possible impacts on offspring health. The cohort will provide scientific basic for improvement of mother and infant's health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5216
• Est. completion date: September 30, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Pregnant women who have plan to delivery and participate in child care in Huizhou hospital;
• Pregnant women who have resided in Huizhou for at least 3 years;
• Pregnant women who are consent for specimens and data collection and follow-ups for both mother and infant.

Exclusion Criteria:

• Pregnant women who are with gestational age more than 24 weeks ;
• Pregnant women who refuse to participate or be unwilling to sign informed consent;
• Pregnant women who are mentally incapacitated and need guardians.

Related Conditions & MeSH terms

• Allergic Disorder
• Anemia in Pregnancy
• Asthma
• Complications, Pregnancy
• Depression
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Gestational Hypertension
• Hypersensitivity
• Hypertension, Pregnancy-Induced
• Immune System Diseases
• Neurodevelopmental Disorders
• Obesity
• Obstetric Labor Complications
• Pregnancy Complications
• Pregnancy in Diabetics
• Reproductive Disorder
• Thyroid Disease Pregnancy
• Thyroid Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	School of Public Health of Sun Yat-sen University (North Campus)	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Huizhou No.1 Maternal and Child Care Service Cencer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse birth outcomes.	Including dystocia,stillbirth, fetal macrosomia and child with birth defect.	At delivery.
Primary	Children weight changes.	Weight is measured in kilograms.	At age of 1 month, 3 months, 6months, 1 year, and 3 year.
Primary	Children height changes.	Height is measured in meters.	At age of 1 month, 3 months, 6months, 1 year, and 3 year.
Primary	Number of participant with gestational complications.	Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.	At delivery.
Secondary	Maternal weight changes(kg).	Assess using electronic weighing machine and body composition analyzer.	At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.
Secondary	Number of participant with postnatal depression.	Assess using Edinburgh Postnatal Depression Scale (EPDS). The total score of scale is 30 ,and higher score indicates worse status.	At 30 days after delivery.