Shanghai Clinical Cohort-Hyperglycemia in Pregnancy (Reserved)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Composite Adverse Maternal and Neonatal Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant individuals who provide written informed consent
- •At enrollment, meet one of the following:
- •1. Gestational diabetes mellitus (GDM) diagnosed by a 75-g oral glucose tolerance test (OGTT) using Chinese Diabetes Society (CDS) 2024 thresholds (any one of: fasting plasma glucose ≥5.1 mmol/L, 1-h ≥10.0 mmol/L, or 2-h ≥8.5 mmol/L); or
- •Pre-gestational diabetes (type 1 or type 2) documented prior to pregnancy or meeting diabetes criteria at the first prenatal visit (e.g., fasting ≥7.0 mmol/L, 2-h OGTT ≥11.1 mmol/L, or HbA1c ≥6.5%); or
- •At high risk for GDM, defined a priori as ≥1 of the following: prior GDM; prior macrosomic infant (≥4,000 g); pre-pregnancy BMI ≥24 kg/m²; age ≥45 years; high-density lipoprotein cholesterol <1 mmol/L, and/or triglyceride levels >2.8 mmol/L; first-degree family history of diabetes; polycystic ovary syndrome (PCOS); history of coronary heart disease; chronic hypertension and repeated positive fasting urinary glucose in early pregnancy
- •Age ≥18 years at the time of consent
- •Willing and able to attend postpartum assessments (OGTT at 6 weeks, 12 months, and annually thereafter), with planned follow-up ≥3 years
排除标准
- •Current or history of illicit drug use or substance abuse
- •Presence of an active infectious disease, including but not limited to: viral hepatitis, sexually transmitted infections or tuberculosis
- •Any other condition which, in the judgment of the investigator, would make the subject unsuitable for enrollment in the study
结局指标
主要结局
Composite Adverse Maternal and Neonatal Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy
时间窗: 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 Among Pregnant Individuals With Hyperglycemia in Pregnancy (OGTT)
时间窗: 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.
次要结局
- Postpartum Glucose Metabolism Outcomes Among Pregnant Individuals With Hyperglycemia in Pregnancy (HbA1c)(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.)
研究者
Yufan Wang
Chief Physician, Professor
Shanghai General Hospital, China