IRCEP: International Registry of Coronavirus (COVID-19) Exposure in Pregnancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pregnant Women Women who are currently pregnant |
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
|
| Post-partum women Women who have been pregnant in the past 6 months |
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
|
Outcome Measures
Primary Outcome Measures
- Pregnancy outcomes [1 year]
Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery
- Birth outcomes [Birth to 90 days post-partum]
Major structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health
- Birth outcomes [Birth to 90 days post-partum]
Head circumference at birth in centimeters
- Birth outcomes [Birth to 90 days post-partum]
Length at birth in centimeters
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pregistry | Los Angeles | California | United States | 90045 |
Sponsors and Collaborators
- Pregistry
- Harvard School of Public Health (HSPH)
Investigators
- Principal Investigator: Diego Wyszynski, MD, MHS, PhD, CEO Pregistry
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0001