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
Study Type
OBSERVATIONAL
Enrollment
3,000
Shanghai General Hospital, China
Shanghai, Shanghai Municipality, China
RECRUITINGComposite 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.
Time frame: 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.
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.
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.
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.
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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.
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
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.
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
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.
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
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.
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.