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

International Registry of Coronavirus Exposure in Pregnancy (IRCEP)

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.

Study Overview

• Status: Completed
• 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

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 Type: Observational
• Enrollment (Actual): 17318

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Pregistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, or women who have been pregnant in the last 6 months, who were tested for SARS-CoV-2 (regardless of the result) or were clinically diagnosed with COVID-19 by a health care professional.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Pregistry
• Collaborators: Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Diego Wyszynski, MD, MHS, PhD, CEO Pregistry

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 0001 (Cancer Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No