No-worry Baby Project

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03922087

Collaborator

Huizhou No.1 Maternal and Child Care Service Cencer (Other)

10,000

Enrollment

Location

85.4

Anticipated Duration (Months)

117.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Mellitus in Pregnancy Gestational Hypertension Thyroid Disease Pregnancy Obesity Anemia in Pregnancy Complications, Pregnancy Depression Obstetric Labor Complications Asthma Allergic Disorder Immune System Diseases Neurodevelopmental Disorders Reproductive Disorder	Other: No intervention

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Huizhou Mother-infant Cohort

Actual Study Start Date :

Nov 20, 2018

Actual Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Control Group The pregnancy women without any diseases.	Other: No intervention No intervention
Disease Group 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 No intervention

Arm

Intervention/Treatment

Control Group

The pregnancy women without any diseases.

Other: No intervention

No intervention

Disease Group

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

No intervention

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Maternal weight changes(kg). [At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.]
Assess using electronic weighing machine and body composition analyzer.
Number of participant with postnatal depression. [At 30 days after delivery.]
Assess using Edinburgh Postnatal Depression Scale (EPDS). The total score of scale is 30 ,and higher score indicates worse status.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.