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临床试验/NCT04366986
NCT04366986已完成不适用

International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Pregistry1 个研究点 分布在 1 个国家目标入组 17,318 人开始时间: 2020年6月23日最近更新:
适应症

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

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

研究者

发起方
Pregistry
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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