Maternal Morbidity and Mortality During the COVID-19 Pandemic

Completed

Conditions studied: COVID-19, Pregnancy Complications

In brief

A cohort study of women who deliver at select sites on randomly selected days in 2019 and 2020, and all confirmed COVID-19 infections among pregnant or immediately postpartum women in 2020. The study population includes approximately 24,400 deliveries on randomly selected days in 2019 and 2020, and an additional 1000-2100 confirmed COVID-19 infections among pregnant women or immediately postpartum.

Key facts

Study ID

NCT04519502

Run by

The George Washington University Biostatistics Center

People needed

25604

Starts

2020-06-23

Expected to finish

2021-11-04

Last updated by the study team

2023-03-27

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who deliver at a selected hospital participating in the MFMU Network on selected dates sent by the Data Coordinating Center from March 1, 2019, through Dec, 31, 2019. Women delivered in the calendar year 2019 will serve as the controls (before pandemic).
• Women who deliver at a selected hospital participating in the MFMU Network on selected dates sent by the Data Coordinating Center from March 1, 2020, through Dec, 31, 2020. Women delivered in the calendar year 2020 will be considered as deliveries during the pandemic (research question 1) and non-confirmed positives as controls (research question 2).
• Pregnant and postpartum (within 6 weeks of delivery) women with confirmed COVID-19 infection from March 1, 2020, through Dec, 31, 2020 and who deliver on or before December 31, 2020. Both those with COVID-19 infection requiring in-patient management and those managed as out-patients will be included. Confirmed COVID-19 infection is defined as a positive COVID-19 viral (i.e., nucleic acid or antigen tests) test during pregnancy through 42 days postpartum.

You may not qualify if…

• Multifetal gestation higher than twins

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Northwestern University — Chicago, Illinois, United States
• Columbia University-St. Luke's Hospital — New York, New York, United States
• University of North Carolina-Chapel Hill — Chapel Hill, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
• Brown Univeristy — Providence, Rhode Island, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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