Plain English Summary
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
There is insufficient information on the potential effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on pregnant women and their developing offspring. However, these populations are classified as vulnerable.
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) aims to describe the natural history of Coronavirus Disease 2019 (COVID-19) in pregnant women and to estimate the risk of major pregnancy-related outcomes among women with varying degrees of severity and of timing of COVID-19 exposure.
Who can participate?
Adult pregnant women with clinical confirmation of COVID-19 or tested for SARS-CoV-2 at any time during their pregnancy.
What does the study involve?
Registration and participation will be via the website or mobile app specially developed for the IRCEP. The IRCEP will collect data on the mother's social background, behaviors, reproductive history, chronic conditions, use of medications, and of healthcare utilization, on COVID-19 infection (symptoms, test results, treatment, and resolution), and information related to pregnancy, childbirth, and the health of the child. Follow-up will include questions at various time points during the pregnancy and will continue through the infant’s first 90 days of life.
What are the possible benefits and risks of participating?
Benefits: By joining the IRCEP and answering the questions, participants can help improve care for other pregnant women with COVID-19 in the future. Additionally, participants will be able to see how their pregnancy experiences compare to those of other women in the study, since aggregate results of the Registry will be reported to participants.
Risks: There are no known physical risks of taking part in the IRCEP. But, like any online activity, there is always a risk of loss of privacy.
Where is the study run from?
Pregistry LLC (USA)
When is the study starting and how long is it expected to run for?
March 2020 to April 2024
Who is funding the study?
Pregistry LLC (USA)
Who is the main contact?
Dr Diego Wyszynski, diegow@pregistry.com
Trial website
Contact information
Type
Public
Primary contact
Dr Diego Wyszynski
ORCID ID
http://orcid.org/0000-0001-6293-3429
Contact details
8 Albert Road
London
90067
United States of America
+1 (747) 200-5468
diegow@pregistry.com
Type
Public
Additional contact
Dr Sonia Hernandez-Diaz
ORCID ID
http://orcid.org/0000-0003-1458-7642
Contact details
677 Huntington Avenue
Boston
02115
United States of America
+1 (617) 432-3942
shernan@hsph.harvard.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT04366986
Protocol/serial number
Nil known
Study information
Scientific title
International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
Acronym
IRCEP
Study hypothesis
COVID-19 during pregnancy increases the risk of obstetrical, neonatal, and infant abnormal outcomes.
Ethics approval
Approved 08/06/2020, Institutional Review Board (IRB) of the Harvard T.H. Chan School of Public Health (90 Smith Street, 3rd Floor Boston, MA 02120, USA; +1 (617) 432-5132; kninsala@hsph.harvard.edu), ref: # IRB20-0622
Study design
Prospective observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Internet
Trial type
Other
Patient information sheet
https://corona.pregistry.com/faq
Condition
COVID-19 (SARS-CoV-2 infection) during pregnancy
Intervention
The IRCEP will be an observational cohort study with prospective and retrospective components. Registration and participation via website or mobile app specially developed for the IRCEP will be voluntary. Women 18 years of age and older will be encouraged to enrol if at any time during pregnancy, they had a test performed for the coronavirus (regardless of the result) or if they had clinical confirmation of COVID-19 in the absence of a SARS-CoV-2 test. Women with confirmed COVID-19 via clinical or test methods will be included in the exposed group and women with a negative test will be included in the control group. Eligible women will be able to enrol at any time during gestation. Given the public health emergency due to the COVID-19 pandemic and the urgent need for data, the IRCEP will also enrol eligible women retrospectively during the first 180 days after delivery (if they delivered after December 2019).
As numbers accumulate, the natural history of COVID-19 during pregnancy will be reported stratified by days since COVID-19 confirmation at enrollment (i.e., from prospective if immediate to retrospective if enrolled after resolution) and the risk of pregnancy outcomes by COVID-19 exposure group will be reported stratified by trimester at enrollment. For the assessment of miscarriages, only participants enrolled during the first trimester will be included and the analyses will be stratified by gestational week at enrollment. For other outcomes, the primary analysis will include all enrollees. However, sensitivity analyses of 1) teratogenicity will be restricted to participants enrolled before an informative prenatal screening was done; 2) late-pregnancy outcomes (e.g. preeclampsia) will be restricted to participants enrolled before the third trimester; and 3) delivery or neonatal outcomes will be restricted to participants enrolled before delivery.
Information will be obtained directly from the participating women. Given the international nature of the IRCEP, the questionnaires will be available in 7 languages (English, Spanish, French, German, Italian, Mandarin, and Farsi). Participant confidentiality and anonymity will be strictly upheld. The IRCEP will collect data on potential confounding factors (such as maternal sociodemographic characteristics, behaviors, reproductive history, chronic conditions, use of medications, and measures of healthcare utilization), on COVID-19 infection (symptoms, test results, treatment, and resolution), and information related to obstetric and neonatal outcomes. Follow-up will include questions at various time points during the pregnancy and will continue through the infant’s first 90 days of life.
There are two main data analyses: 1) a real-time descriptive surveillance that will report the COVID-19 characteristics and the frequency of outcomes in the exposed and control groups, and 2) hypothesis-based causal inference analyses that will investigate the potential effects of specific COVID-19 characteristics or treatments and will adjust through multivariate regression models or using propensity score (PS) matching to account for potential confounders, as appropriate.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Measured by maternal self-report using online questionnaire at baseline:
1. Pregnancy outcomes:
1.1. Miscarriage (or spontaneous abortion)
1.2. Elective termination
1.3. Stillbirth
1.4. Preterm delivery
2. Birth outcomes (measured at additional time points up to 90 days):
2.1. Major structural defects
2.2. Neonatal death
2.3. Admission into the Neonatal Intensive Care Unit
2.4. Maternal obstetric complications
2.5. Post-partum health
Secondary outcome measures
Measured by maternal self-report using online questionnaire:
1. Head circumference (cm) at each time point from baseline to 90 days.
2. Length at birth (cm)
Overall trial start date
08/03/2020
Overall trial end date
30/04/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult pregnant women with clinical confirmation of COVID-19 or tested for SARS-CoV-2 at any time during their pregnancy
Participant type
All
Age group
Adult
Gender
Female
Target number of participants
25,000
Participant exclusion criteria
Subjects who do not meet the inclusion criteria
Recruitment start date
08/06/2020
Recruitment end date
30/04/2024
Locations
Countries of recruitment
Afghanistan, Aland Islands, Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bonaire Saint Eustatius and Saba, Bosnia and Herzegovina, Botswana, Bouvet Island, Brazil, British Indian Ocean Territory, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Cape Verde, Cayman Islands, Central African Republic, Chad, Chile, China, Christmas Island, Cocos (Keeling) Islands, Colombia, Comoros, Congo, Congo, Democratic Republic, Cook Islands, Costa Rica, Cote d'Ivoire, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Ethiopia, Falkland Islands, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Grenada, Guadeloupe, Guam, Guatemala, Guernsey, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and Mcdonald Islands, Holy See (Vatican City State), Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kiribati, Korea, North, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Mexico, Micronesia, Federated States of, Moldova, Monaco, Mongolia, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Niue, Norfolk Island, Northern Mariana Islands, Norway, Oman, Pakistan, Palau, Palestinian Territory, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saint Barthelemy, Saint Helena, Saint Kitts and Nevis, Saint Lucia, Saint Martin (French part), Saint Pierre and Miquelon, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Sint Maarten (Dutch part), Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Georgia and the South Sandwich Is, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Svalbard and Jan Mayen, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States Minor Outlying Islands, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela, Viet Nam, Virgin Islands, British, Virgin Islands, U.S., Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe
Trial participating centre
Pregistry
1801 Century Park East, 25th Floor
Los Angeles
90067
United States of America
Sponsor information
Organisation
Pregistry LLC
Sponsor details
1801 Century Park East
25th Floor
Los Angeles
90067
United States of America
+1 (747) 200-5468
hello@pregistry.com
Sponsor type
Other
Website
Funders
Funder type
Industry
Funder name
Pregistry LLC
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from the International Registry of Coronavirus Exposure in Pregnancy (ircep@pregistry.com). De-identified data will be provided to applicants who submit a research study protocol approved by the Registry’s Leadership Team and the Scientific Advisory Committee.
Intention to publish date
01/05/2024
Participant level data
Available on request
Basic results (scientific)
Publication list