Gestatiaonl Diabetes MellitusGREATNCT07125885
Gongji Pregnancy Endorine Cohort Study
An observational study of Gestatiaonl Diabetes Mellitus and Thyroid Disease Pregnancy, run by Shanghai General Hospital, China at 1 site in China.
Trial summary
To explore the relationship between genetic factors, lifestyle, and drug interventions and the occurrence, development, adverse pregnancy outcomes, and postpartum maternal-infant outcomes of gestational endocrine diseases. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestatiaonl Diabetes Mellitus, Thyroid Disease Pregnancy, Hyperglycemia in Pregnant Diabetic Patients
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2023to 31 Dec 2043
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Adult
Study population: The study will include patients who receive routine prenatal care, delivery, and postpartum endocrinology follow-up at Shanghai General Hospital
Who may be able to join
- Women preparing for pregnancy or pregnant women or within 1 year after giving birth
- Age ≥ 18 years old
- Signed the informed consent form to voluntarily enroll in the management follow-up
Who cannot join
- Individuals who are unable to communicate normally and those who are unwilling to cooperate
- Pregnant women with severe organic diseases or mental illnesses
- Any condition deemed by the investigator to affect eligibility for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital, China
Shanghai, Shanghai Municipality, 200080
Yufan Wang, PhD, (+86) 021-63240090, yyffwang@sina.com
About this study
Official title: Serological, Metabolomic, and Genomic Studies of Endocrine Disorders in Pregnancy
To explore the relationship between genetic factors, lifestyle, and drug interventions and the occurrence, development, adverse pregnancy outcomes, and postpartum maternal-infant outcomes of gestational endocrine diseases.
Read the detailed description
Time Perspective: Prospective and retrospective
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders
Unit of Measure: Percentage of pregnancies with ≥ 1 event (%) Description: The composite will be coded as Yes/No. An event is counted if any of the following occurs: preeclampsia, cesarean delivery, premature rupture of membranes, placental abruption, preterm birth, congenital malformations, macrosomia, large for gestational age, small for gestational age, neonatal hypoglycemia, neonatal hyperbilirubinemia, neonatal respiratory distress syndrome, neonatal intensive care unit admission, obstetric trauma or still birth. Data abstracted from electronic medical records.
Measured: From delivery (Day 0) through the initial birth hospitalization, assessed up to 14 days postpartum.
Postpartum glucose metabolism outcomes in patients with endocrine disorders in pregnancy
Percentage of patients with diabetes mellitus (%) Postpartum glucose metabolism will be assessed using an oral glucose tolerance test (OGTT) to determine the incidence of diabetes mellitus. Data will be collected from blood tests and medical records.
Measured: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Postpartum thyroid disease outcomes in patients with endocrine disorders in pregnancy
Unit of Measure: Changes in serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels (mU/L, pg/mL) Postpartum thyroid disease outcomes will be evaluated by measuring serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels. Changes in these biomarkers will be used to assess thyroid function recovery or progression of thyroid dysfunction (e.g., hypothyroidism or hyperthyroidism) postpartum. These levels will be compared to baseline values, which include both pre-pregnancy and pregnancy-associated measurements. Data will be obtained from blood tests and medical records.
Measured: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Secondary outcomes (4)
Incidence of abnormal glucose metabolism in offspring of women with gestational endocrine diseases
Unit of Measure: Cumulative incidence of abnormal glucose metabolism (%) Abnormal glucose metabolism in offspring will be measured by conducting oral glucose tolerance tests (OGTT) and/or HbA1c tests. Data will be collected from clinical records and blood tests.
Measured: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Incidence of thyroid disorders in offspring of women with gestational endocrine diseases
Unit of Measure: Percentage of offspring with thyroid disorders (%) Thyroid disorders in offspring will be diagnosed by measuring serum thyroid-stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3) levels. Data will be obtained from blood tests and medical records.
Measured: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Growth Abnormalities in Offspring of Women with Gestational Endocrine Diseases
Unit of Measure: Body Mass Index (BMI) (kg/m²) Growth abnormalities in offspring will be assessed through anthropometric measurements including weight (kg) and height (m). BMI will be calculated using the formula: BMI = weight (kg) / height² (m²). Data will be collected from routine pediatric examinations and medical records.
Measured: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Developmental abnormalities in offspring of women with gestational endocrine diseases
Unit of Measure: Percentage of offspring with developmental abnormalities (%) Developmental abnormalities will be assessed through motor skills evaluations (e.g., fine and gross motor skills) and cognitive development assessments. Data will be collected from routine pediatric evaluations and medical records.
Measured: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start5 May 2023
- Primary completion31 Dec 2043 (estimated)
- Study completion31 Dec 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestatiaonl Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yufan Wang, Shanghai General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125885
- Sponsor's protocol ID
- 2022SQ506
- Acronym
- GREAT
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological, Metabolomic, and Genomic Studies of Endocrine Disorders in Pregnancy
- ClinicalTrials.gov ID
- NCT07125885
- Acronym / sponsor ID
- GREAT / 2022SQ506
- Conditions
- Gestatiaonl Diabetes Mellitus, Thyroid Disease Pregnancy, Hyperglycemia in Pregnant Diabetic Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, ChinaUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Dec 2043 (estimated)
- Study completion
- 31 Dec 2043 (estimated)
- First posted
- 15 Aug 2025 (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.
To explore the relationship between genetic factors, lifestyle, and drug interventions and the occurrence, development, adverse pregnancy outcomes, and postpartum maternal-infant outcomes of gestational endocrine diseases.
Detailed description
Time Perspective: Prospective and retrospective
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study will include patients who receive routine prenatal care, delivery, and postpartum endocrinology follow-up at Shanghai General Hospital
Key inclusion criteria (3 listed)
- Women preparing for pregnancy or pregnant women or within 1 year after giving birth
- Age ≥ 18 years old
- Signed the informed consent form to voluntarily enroll in the management follow-up
Key exclusion criteria (3 listed)
- Individuals who are unable to communicate normally and those who are unwilling to cooperate
- Pregnant women with severe organic diseases or mental illnesses
- Any condition deemed by the investigator to affect eligibility for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders
Time frame: From delivery (Day 0) through the initial birth hospitalization, assessed up to 14 days postpartum.
Unit of Measure: Percentage of pregnancies with ≥ 1 event (%) Description: The composite will be coded as Yes/No. An event is counted if any of the following occurs: preeclampsia, cesarean delivery, premature rupture of membranes, placental abruption, preterm birth, congenital malformations, macrosomia, large for gestational age, small for gestational age, neonatal hypoglycemia, neonatal hyperbilirubinemia, neonatal respiratory distress syndrome, neonatal intensive care unit admission, obstetric trauma or still birth. Data abstracted from electronic medical records.
Postpartum glucose metabolism outcomes in patients with endocrine disorders in pregnancy
Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Percentage of patients with diabetes mellitus (%) Postpartum glucose metabolism will be assessed using an oral glucose tolerance test (OGTT) to determine the incidence of diabetes mellitus. Data will be collected from blood tests and medical records.
Postpartum thyroid disease outcomes in patients with endocrine disorders in pregnancy
Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Unit of Measure: Changes in serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels (mU/L, pg/mL) Postpartum thyroid disease outcomes will be evaluated by measuring serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels. Changes in these biomarkers will be used to assess thyroid function recovery or progression of thyroid dysfunction (e.g., hypothyroidism or hyperthyroidism) postpartum. These levels will be compared to baseline values, which include both pre-pregnancy and pregnancy-associated measurements. Data will be obtained from blood tests and medical records.
4 secondary outcomes
Incidence of abnormal glucose metabolism in offspring of women with gestational endocrine diseases
Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Incidence of thyroid disorders in offspring of women with gestational endocrine diseases
Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Growth Abnormalities in Offspring of Women with Gestational Endocrine Diseases
Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Developmental abnormalities in offspring of women with gestational endocrine diseases
Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Gestatiaonl Diabetes Mellitus and Thyroid Disease Pregnancy, run by Shanghai General Hospital, China 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yufan Wang, PhD ((+86) 021-63240090, yyffwang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders (time frame: From delivery (Day 0) through the initial birth hospitalization, assessed up to 14 days postpartum.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.