NCT04366986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

April 23, 2020

Last Update Submit

September 27, 2021

Conditions

Covid-19

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Pregnant Women

Women who are currently pregnant

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

Post-partum women

Women who have been pregnant in the past 6 months

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

Interventions

Tested for SARS-CoV-2 (regardless of the result)OTHER

This is an observational study with no intervention

Post-partum womenPregnant Women
Clinical diagnosis of COVID-19 by a health care professionalOTHER

This is an observational study with no intervention

Post-partum womenPregnant Women

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPersons assigned gender female at birth.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pregistry

Los Angeles, California, 90045, United States

Location

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Diego Wyszynski, MD, MHS, PhD

    CEO Pregistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 29, 2020

Study Start

June 23, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)