Establish a high-quality clinical cohort of hyperglycemia in pregnancy. Develop subtype-specific, end-to-end standards for diagnosis, treatment, and follow-up across the preconception, pregnancy, and postpartum phases. These standards will lay a solid foundation for efficient, high-quality clinical research.
Study Type
OBSERVATIONAL
Enrollment
4,000
Shanghai General Hospital, China
Shanghai, Shanghai Municipality, China
RECRUITINGComposite Adverse Maternal and Neonatal Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy
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 Among Pregnant Individuals With Hyperglycemia in Pregnancy (OGTT)
Unit of Measure: Percentage of patients with abnormal glucose metabolism based on OGTT (%) Description: This measure will assess the incidence of abnormal glucose metabolism using an oral glucose tolerance test (OGTT). Abnormal glucose metabolism will be defined as: fasting glucose ≥6.1 mmol/L or 2-hour glucose ≥7.8 mmol/L. 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 10 years postpartum.
Postpartum Glucose Metabolism Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy (HbA1c)
Unit of Measure: Percentage of patients with abnormal Hemoglobin A1c (HbA1c, %) Description: This measure will assess the incidence of abnormal glucose metabolism based on HbA1c testing. Abnormal glucose metabolism will be defined as an HbA1c ≥6.5%. 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 10 years postpartum.
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