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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.
Time Perspective: Prospective and retrospective
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include patients who receive routine prenatal care, delivery, and postpartum endocrinology follow-up at Shanghai General Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yufan Wang, PhD | Contact | (+86) 021-63240090 | yyffwang@sina.com | |
| Na Li, PhD | Contact | +8613636352801 | lena0113@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital, China | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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Data will be uploaded to Zenodo and shared, starting 9 months and ending 36 months following article publication
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Stool, Serum/Plasma, Urine, Placenta
| 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. | 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. | 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. | 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. |