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

Covid-19 Clinical Trial

— IRCEP  

Official title:

International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366986
• Other study ID #: 0001
• Status: Completed
• Start date: June 23, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Pregistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17318
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19

Intervention

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

Locations

Country	Name	City	State
United States	Pregistry	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Pregistry	Harvard School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy outcomes	Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery	1 year
Primary	Birth outcomes	Major structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health	Birth to 90 days post-partum
Primary	Birth outcomes	Head circumference at birth in centimeters	Birth to 90 days post-partum
Primary	Birth outcomes	Length at birth in centimeters	Birth to 90 days post-partum

External Links

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