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

International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04366986
Acronym
IRCEP
Enrollment
17318
Registered
2020-04-29
Start date
2020-06-23
Completion date
2021-08-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

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.

Interventions

OTHERTested for SARS-CoV-2 (regardless of the result)

This is an observational study with no intervention

OTHERClinical diagnosis of COVID-19 by a health care professional

This is an observational study with no intervention

Sponsors

Harvard School of Public Health (HSPH)
CollaboratorOTHER
Pregistry
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pregnancy outcomes1 yearMiscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery
Birth outcomesBirth to 90 days post-partumMajor structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026