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CompletedNCT03922087Updated Nov 28, 2023

No-worry Baby Project

An observational study in Gestational Diabetes Mellitus in Pregnancy, Gestational Hypertension and Thyroid Disease Pregnancy, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,216
Ages
18 Years to 49 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Hypertension, Pregnancy-Induced

245 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 68 are open to participants now.

This study's enrollment of 5,216 is above the median of 225 across 70 observational studies indexed under Hypertension, Pregnancy-Induced.

Browse Hypertension, Pregnancy-Induced studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,216 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Number of adverse birth outcomes.

    Including dystocia,stillbirth, fetal macrosomia and child with birth defect.

    Time frame: At delivery.

  2. Children weight changes.

    Weight is measured in kilograms.

    Time frame: At age of 1 month, 3 months, 6months, 1 year, and 3 year.

  3. Children height changes.

    Height is measured in meters.

    Time frame: At age of 1 month, 3 months, 6months, 1 year, and 3 year.

  4. Number of participant with gestational complications.

    Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.

    Time frame: At delivery.

Secondary outcomes

  1. Maternal weight changes(kg).

    Assess using electronic weighing machine and body composition analyzer.

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

  2. 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.

    Time frame: At 30 days after delivery.

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Study locations

1 site
  • School of Public Health of Sun Yat-sen University (North Campus)
    Guangzhou, Guangdong 51000, China
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References and documents

Publications

  • 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. PubMed 39609361 ↗
  • 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. PubMed 35909297 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03922087
Collaborators
Huizhou No.1 Maternal and Child Care Service Cencer
Responsible party
LIU ZHAOMIN (Professor in Department of Nutrition and Food Hygiene, Sun Yat-sen University) — Principal investigator
First posted
Apr 19, 2019
Start date
Nov 20, 2018
Primary completion
Apr 1, 2022
Completion
Sep 30, 2023
Last update
Nov 28, 2023

Study contacts

Zhaomin Liu, Doctor
principal investigator · School of Public Health of Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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