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NCT Number: NCT07125885

Gongji Pregnancy Endorine Cohort Study

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.

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Key information

Conditions

Gestatiaonl Diabetes Mellitus Hyperglycemia in Pregnant Diabetic Patients Thyroid Disease Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Shanghai General Hospital, China

Shanghai, Shanghai Municipality, 200080, China

Location status: Recruiting

Location contact

Yufan Wang, PhD

CONTACT

[email protected]

(+86) 021-63240090

About this study

Time Perspective: Prospective and retrospective

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Na Li, PhD

CONTACT

[email protected]

+8613636352801

Yufan Wang, PhD

CONTACT

[email protected]

(+86) 021-63240090

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, China

Other

Registry information

Official study title

Serological, Metabolomic, and Genomic Studies of Endocrine Disorders in Pregnancy

Acronym: GREAT

Important dates

Study start
2023
Primary completion
2043
Study completion
2043
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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