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

Study 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.

Official Title
-----------------
International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Conditions
-----------------
Covid-19

Intervention / Treatment
-----------------
* Other: Tested for SARS-CoV-2 (regardless of the result)
* Other: Clinical diagnosis of COVID-19 by a health care professional


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women<br>Women who are currently pregnant | Other: Tested for SARS-CoV-2 (regardless of the result)<br>* This is an observational study with no intervention<br>Other: Clinical diagnosis of COVID-19 by a health care professional<br>* This is an observational study with no intervention<br>|
| Post-partum women<br>Women who have been pregnant in the past 6 months | Other: Tested for SARS-CoV-2 (regardless of the result)<br>* This is an observational study with no intervention<br>Other: Clinical diagnosis of COVID-19 by a health care professional<br>* This is an observational study with no intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcomes | Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery | 1 year | 
| 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 | 
| Birth outcomes | Head circumference at birth in centimeters | Birth to 90 days post-partum | 
| Birth outcomes | Length at birth in centimeters | Birth to 90 days post-partum |