Shanghai General Hospital, China
Shanghai, Shanghai Municipality, 200080, China
Location status: Recruiting
NCT Number: NCT07161947
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Shanghai, Shanghai Municipality, 200080, China
Location status: Recruiting
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Shanghai General Hospital, China
Other
Shanghai Clinical Cohort-Hyperglycemia in Pregnancy (Reserved)
Acronym: SHINE
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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