Gongji Pregnancy Endorine Cohort Study

Recruiting

• Conditions: Gestatiaonl Diabetes Mellitus; Hyperglycemia in Pregnant Diabetic Patients; Thyroid Disease Pregnancy

• Registration Number: NCT07125885
• Lead Sponsor: Shanghai General Hospital, China

Brief 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.

Detailed Description

Time Perspective: Prospective and retrospective

Study Timeline

• Study Start: 2023-05-05
• Study First Submitted: 2025-07-12
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-09
• Last Update Submitted: 2025-08-09
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2043-12-31
• Study Completion: 2043-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders	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	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	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 Outcome Measures

Name	Time	Method
Incidence of abnormal glucose metabolism in offspring of women with gestational endocrine diseases	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.
Incidence of thyroid disorders in offspring of women with gestational endocrine diseases	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.
Growth Abnormalities in Offspring of Women with Gestational Endocrine Diseases	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.
Developmental abnormalities in offspring of women with gestational endocrine diseases	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.

Trial Locations

Locations (1)

Shanghai General Hospital, China; 🇨🇳 Shanghai, Shanghai, China