PRIORITY (Pregnancy Coronavirus Outcomes Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,333
- 试验地点
- 1
- 主要终点
- Clinical presentation
研究概览
简要总结
PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for COVID-19 or a confirmed case of COVID-19. Data from PRIORITY will be used to evaluate the impact of COVID-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.
详细描述
The investigators will recruit women age 13 or older under investigation for COVID-19 or with confirmed COVID-19 at any clinical state across the United States. Eligible participants will be identified through voluntary physician referrals.
When an eligible patient is referred to the PRIORITY Coordinating Center at UCSF, a UCSF study coordinator will follow-up by phone with the patient and consent verbally. The participant will be asked to complete an approval to release medical information. The investigators will use patient questionnaires to assess symptoms, maternal clinical course, pregnancy outcomes, and neonatal outcomes from initial investigation of COVID-19 to 12 months. The investigators will also obtain all medical records for the participant to data abstract key clinical and pregnancy outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women or women who have been pregnant within the last 6 weeks
- •Able to give informed consent
- •Diagnosed with COVID-19; or being evaluated for COVID-19 ("patient under investigation") since January 1, 2020
排除标准
- •<13 years of age.
结局指标
主要结局
Clinical presentation
时间窗: Baseline to 12 months
presenting symptoms and testing
Disease prognosis outcomes
时间窗: Baseline to 12 months
Clinical outcomes with resolution of illness
Neonatal outcomes
时间窗: Baseline to 12 months
Neonatal outcomes among infants born to women with COVID-19
Obstetric outcomes
时间窗: Baseline to 12 months
Obstetric outcomes among women infected with COVID-19
Pregnancy outcomes
时间窗: Baseline to 12 months
Pregnancy outcomes among women infected with COVID-19
Modes of transmission of COVID-19
时间窗: Baseline to 12 months
Transmission of COVID-19 from mother to infant
次要结局
未报告次要终点