International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17,318
- 试验地点
- 1
- 主要终点
- Birth outcomes
研究概览
简要总结
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.
详细描述
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) will enroll women 18 years of age and older who are currently pregnant or have been pregnant women within the last 6 months, and who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. As this is an international registry, women from all countries are welcome to participate.
Women will enroll and provide information to the IRCEP via website and mobile app. After signing the electronic informed consent document, registrants will answer questions on the following modules: Demographics, Reproductive History, Height and Weight, Habits, Health Conditions, Medications, Current Pregnancy, COVID-19 Infection Test, and COVID-19 Infection Symptoms. Monthly follow-up modules will continue until the pregnancy outcome. In case of a live birth, the Registry participant will continue with the Post-Partum Outcomes module until the newborn is 90 days of age. Medical records from the mother and neonate will also be requested.
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
- 18 Years 至 —(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 months
- •Able to give electronic informed consent
- •Tested for SARS-CoV-2 (regardless of the result) or clinically diagnosed with COVID-19 by a health care professional
排除标准
- •<18 years of age
结局指标
主要结局
Birth outcomes
时间窗: Birth to 90 days post-partum
Length at birth in centimeters
Pregnancy outcomes
时间窗: 1 year
Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery
次要结局
未报告次要终点
