Serological, Metabolomic, and Genomic Studies of Endocrine Disorders in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders
研究概览
简要总结
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.
详细描述
Time Perspective: Prospective and retrospective
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women preparing for pregnancy or pregnant women or within 1 year after giving birth
- •Age ≥ 18 years old
- •Signed the informed consent form to voluntarily enroll in the management follow-up
排除标准
- •Individuals who are unable to communicate normally and those who are unwilling to cooperate
- •Pregnant women with severe organic diseases or mental illnesses
- •Any condition deemed by the investigator to affect eligibility for the study
结局指标
主要结局
Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders
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 in patients with endocrine disorders in pregnancy
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 40 years postpartum.
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.
Postpartum thyroid disease outcomes in patients with endocrine disorders in pregnancy
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 40 years postpartum.
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.
次要结局
- Incidence of abnormal glucose metabolism in offspring of women with gestational endocrine diseases(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(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(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(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.)
研究者
Yufan Wang
Chief Physician, Professor
Shanghai General Hospital, China