No-worry Baby Project

NCT03922087 | Completed

• 1 other identifier: HZT2018
• Study Type: observational
• Target: 5,216
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Maternal weight changes(kg).

  At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.

• Number of participant with postnatal depression.

  At 30 days after delivery.

Study Arms (2)

Control Group

The pregnancy women without any diseases.

Other: 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

Interventions

No intervention OTHER

No intervention

Control Group; Disease Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Huizhou No.1 Maternal and Child Care Service Cencer: collaborator

Study Sites (1)

School of Public Health of Sun Yat-sen University (North Campus)

Guangzhou, Guangdong, 51000, China

Location

Related Publications (2)

• Liu ZM, Long HH, Li D, Fang AP, Chen CG, Wang C, Li MM, Wu Y, Zhang SJ, Pan WJ. Maternal Serum Iodine Concentrations in Early Pregnancy Exhibited Well Diagnostic Ability for Thyroid Dysfunction, Inverse Associations with Gestational Weight Gain, and Birth Size: Longitudinal Analyses Based on Huizhou Mother-Infant Cohort. Biol Trace Elem Res. 2025 Jul;203(7):3618-3629. doi: 10.1007/s12011-024-04443-7. Epub 2024 Nov 29.

  PMID: 39609361 DERIVED

• 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.

  PMID: 35909297 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

During pregnancy: maternal vein blood at mid- and last trimester, spot and 12-hr urine and feces at mid-trimester; At delivery: umbilical cord blood, placenta , umbilical cord, mother's milk. Postnatal: mother's vein blood During infancy: meconium. During childhood: Mother's milk and baby's feces.

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Obesity; Pregnancy Complications; Depression; Obstetric Labor Complications; Asthma; Hypersensitivity; Immune System Diseases; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Mental Disorders

Study Officials

• Zhaomin Liu, Doctor

  School of Public Health of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Nutrition and Food Hygiene

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 19, 2019
• Study Start: November 20, 2018
• Primary Completion: April 1, 2022
• Study Completion: September 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)