Maternal Morbidity and Mortality During the COVID-19 Pandemic

Status: Completed
Location: See all (12) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama - Birmingham
Birmingham
Illinois
Northwestern University
Chicago
North Carolina
University of North Carolina-Chapel Hill
Chapel Hill
New York
Columbia University-St. Luke's Hospital
New York
Ohio
Case Western Reserve University
Cleveland
Ohio State University
Columbus
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Magee Women's Hospital
Pittsburgh
Rhode Island
Brown Univeristy
Providence
Texas
University of Texas Medical Branch
Galveston
University of Texas - Houston
Houston
Utah
University of Utah Medical Center
Salt Lake City
Time Frame
Start Date: 2020-06-23
Completion Date: 2021-11-04
Participants
Target number of participants: 25604
Treatments
Randomly Selected Delivery Dates 2019
Women who deliver at one of the MFMU Network hospitals on randomly selected days between March 1 and December 31, 2019.
Randomly Selected Delivery Dates 2020
Women who deliver at one of the MFMU Network hospitals on randomly selected days between March 1 and December 31, 2020
Confirmed COVID-19 Infections
Women with confirmed COVID-19 infection between March 1, 2020 and December 31, 2020 and who delivered on or before December 31, 2020.
Sponsors
Leads: The George Washington University Biostatistics Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov