NCT04366986

International Registry of Coronavirus (COVID-19) Exposure in Pregnancy

International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17,318 (actual)
• Sponsor: Pregistry · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid-19

Interventions

Type	Name	Description
OTHER	Tested for SARS-CoV-2 (regardless of the result)	This is an observational study with no intervention
OTHER	Clinical diagnosis of COVID-19 by a health care professional	This is an observational study with no intervention

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2020-04-29
• Last updated: 2021-09-28

Locations

1 site across 1 country: United States