No-worry Baby Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Huizhou Mother-infant Cohort

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

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>The pregnancy women without any diseases. | Other: No intervention<br>* No intervention<br>|
| Disease Group<br>The pregnancy women with cardio-metabolic and endocrinic disorders such as gestational diabetes, obesity, hypertension, thyroid diseases, anemia and other cardio-metabolic diseases. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse birth outcomes. | Including dystocia,stillbirth, fetal macrosomia and child with birth defect. | At delivery. | 
| Children weight changes. | Weight is measured in kilograms. | At age of 1 month, 3 months, 6months, 1 year, and 3 year. | 
| Children height changes. | Height is measured in meters. | At age of 1 month, 3 months, 6months, 1 year, and 3 year. | 
| Number of participant with gestational complications. | Including gestational hypertension and preeclampsia, and gestational diabetes mellitus. | At delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |