Condition category
Infections and Infestations
Date applied
26/10/2020
Date assigned
30/10/2020
Last edited
28/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://ircep.pregistry.com/

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

https://www.pregistry.com

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

Publication citations

Additional files

Editorial Notes

28/10/2020: Trial’s existence confirmed by Harvard T.H. Chan School of Public Health.