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

Completed

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

• Registration Number: NCT04366986
• Lead Sponsor: Pregistry

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.

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Study Start: 2020-06-23
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17318

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women	Clinical diagnosis of COVID-19 by a health care professional	Women who are currently pregnant
Post-partum women	Tested for SARS-CoV-2 (regardless of the result)	Women who have been pregnant in the past 6 months
Pregnant Women	Tested for SARS-CoV-2 (regardless of the result)	Women who are currently pregnant
Post-partum women	Clinical diagnosis of COVID-19 by a health care professional	Women who have been pregnant in the past 6 months

Primary Outcome Measures

Name	Time	Method
Birth outcomes	Birth to 90 days post-partum	Length at birth in centimeters
Pregnancy outcomes	1 year	Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery

Trial Locations

Locations (1)

Pregistry; 🇺🇸 Los Angeles, California, United States