Gestational Diabetes Mellitus in PregnancyNCT03922087
No-worry Baby Project
An observational study of Gestational Diabetes Mellitus in Pregnancy and Gestational Hypertension, run by Sun Yat-sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Gestational Hypertension, Thyroid Disease Pregnancy
- How many people
- 5,216 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2018to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Eligible pregnant women will be recruited from Huizhou First Maternal and Child Care Service Center.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Public Health of Sun Yat-sen University (North Campus)
Guangzhou, Guangdong, 51000
About this study
Official title: 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.
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.
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Gestational Hypertension, Thyroid Disease Pregnancy, Obesity, Anemia in Pregnancy, Complications, Pregnancy
- Being tested
- No intervention
- Medical subject headings
- Hypertension, Pregnancy-Induced, Obesity, Pregnancy Complications, Depression, Obstetric Labor Complications, Asthma, Hypersensitivity, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Control Group | The pregnancy women without any diseases. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse birth outcomes.
Including dystocia,stillbirth, fetal macrosomia and child with birth defect.
Measured: At delivery.
Children weight changes.
Weight is measured in kilograms.
Measured: At age of 1 month, 3 months, 6months, 1 year, and 3 year.
Children height changes.
Height is measured in meters.
Measured: 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.
Measured: At delivery.
Secondary outcomes (2)
Maternal weight changes(kg).
Assess using electronic weighing machine and body composition analyzer.
Measured: 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.
Measured: At 30 days after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start20 Nov 2018
- Primary completion1 Apr 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Huizhou No.1 Maternal and Child Care Service Cencer
- Responsible party
- Principal investigator, LIU ZHAOMIN, Sun Yat-sen University
- Investigators
- Zhaomin Liu, Doctor, Principal investigator, School of Public Health of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922087
- Sponsor's protocol ID
- HZT2018
- Status last verified
- Nov 2023
- First submitted
- 13 Apr 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 39609361Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huizhou Mother-infant Cohort
- ClinicalTrials.gov ID
- NCT03922087
- Acronym / sponsor ID
- HZT2018
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Gestational Hypertension, Thyroid Disease Pregnancy, Obesity, Anemia in Pregnancy, Complications, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,216 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Huizhou No.1 Maternal and Child Care Service Cencer
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: No interventionThe pregnancy women without any diseases. |
| Disease Group | – | Other: No interventionThe pregnancy women with cardio-metabolic and endocrinic disorders such as gestational diabetes, obesity, hypertension, thyroid diseases, anemia and other cardio-metabolic diseases. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eligible pregnant women will be recruited from Huizhou First Maternal and Child Care Service Center.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Control Group, Disease Group |
Primary outcome
Number of adverse birth outcomes.
Time frame: At delivery.
Including dystocia,stillbirth, fetal macrosomia and child with birth defect.
Children weight changes.
Time frame: At age of 1 month, 3 months, 6months, 1 year, and 3 year.
Weight is measured in kilograms.
Children height changes.
Time frame: At age of 1 month, 3 months, 6months, 1 year, and 3 year.
Height is measured in meters.
Number of participant with gestational complications.
Time frame: At delivery.
Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.
2 secondary outcomes
Maternal weight changes(kg).
Time frame: At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.
Number of participant with postnatal depression.
Time frame: At 30 days after delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39609361Liu 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.
- Derived from this study: PubMed 35909297Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaomin Liu, Doctor principal investigator
School of Public Health of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus in Pregnancy and Gestational Hypertension, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse birth outcomes. (time frame: At delivery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 27 Oct 2026.