An Observational Study on the Risk of Adverse Maternal and Infant Outcomes Associated With Respiratory Viral Infections Before and During Early Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,440
- 主要终点
- incidence of gestational diabetes mallitus
研究概览
简要总结
Adverse pregnancy outcomes (APOs) are a collection of conditions that have short-term and long-term effects of complications related to pregnancy and childbirth on pregnant women and their fetuses, including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, large for gestational age, among others. Nearly 30% of all women experience an adverse pregnancy outcome during their reproductive years. Although, respiratory viral infections with epidemic and pandemic potential pose an omnipresent threat to public health, research focusing specifically on the maternal-infant population remains relatively scarce.
Studies conducted in USA found that among pregnant women infected with influenza, the proportion of those with gestational hypertension or diabetes was higher than in pregnant women without influenza infection (13.9% vs. 11.1%).
Research on the impact of respiratory viral infections on perinatal outcomes in China is limited, and we aim to establish of a large-scale, retroprospective maternal-child cohorts. This cohort study will systematically collect longitudinal data (e.g., detailed clinical history, timing of infection/vaccination, complication of pregnancy, and APOs) to assess the risk of respiratory viral infections to APOs, as well as facilitate multidisciplinary research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 45 years old;
- •Physician-diagnosed acute respiratory viral infection occurring within 6 months before pregnancy and/or at <24 weeks of gestation.
排除标准
- •Pregestational T1D or T2D;
- •Long-term use of immunosuppressants or glucocorticoids;
- •Diseases that severely affect immune or metabolic function (e.g., HIV, SLE, rheumatoid arthritis);
- •Severe mental illness or cognitive impairment;
- •Women whose electronic medical records lack GDM screening and delivery records.
结局指标
主要结局
incidence of gestational diabetes mallitus
时间窗: 28 weeks of gestation
incidence of gestational diabetes mallitus according to International Association of Diabetes and Pregnancy Study Groups consensus if any one of the plasma glucose values is met or exceeded during a 75g oral glucose tolerance test (OGTT) at 20 to 28 gestational weeks.
次要结局
- incidence of preterm birth(37 gestational weeks)
研究者
Mei Kang
Associate Professor
Shanghai General Hospital, China