International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid-19
- Sponsor
- Pregistry
- Enrollment
- 17318
- Locations
- 1
- Primary Endpoint
- Birth outcomes
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\<18 years of age
Outcomes
Primary Outcomes
Birth outcomes
Time Frame: Birth to 90 days post-partum
Length at birth in centimeters
Pregnancy outcomes
Time Frame: 1 year
Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery