No-worry Baby Project

Huizhou Mother-infant Cohort

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.

Study Overview

• Status: Completed
• Conditions: Depression; Immune System Diseases; Obesity; Asthma; Obstetric Labor Complications; Neurodevelopmental Disorders; Gestational Diabetes Mellitus in Pregnancy; Gestational Hypertension; Allergic Disorder; Anemia in Pregnancy; Reproductive Disorder; Complications, Pregnancy; Thyroid Disease Pregnancy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 5216

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 51000
      • School of Public Health of Sun Yat-sen University (North Campus)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Eligible pregnant women will be recruited from Huizhou First Maternal and Child Care Service Center.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participant with gestational complications.	Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.	At delivery.
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.

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.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Huizhou No.1 Maternal and Child Care Service Cencer
• Investigators: Principal Investigator: Zhaomin Liu, Doctor, School of Public Health of Sun Yat-sen University

Publications and helpful links

General Publications

• Zhang D, Zhang S, Li G, Lai Y, Hao YT, Chen WQ, Wu Y, Chen C, Pan W, Liu ZM. A clinical model and nomogram for early prediction of gestational diabetes based on common maternal demographics and routine clinical parameters. J Obstet Gynaecol Res. 2022 Nov;48(11):2738-2747. doi: 10.1111/jog.15380. Epub 2022 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 13, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypersensitivity; Thyroid Diseases; Obstetric Labor Complications; Pregnancy Complications; Immune System Diseases; Neurodevelopmental Disorders; Diabetes, Gestational; Pregnancy in Diabetics; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: HZT2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No