Status:
COMPLETED
Maternal Morbidity and Mortality During the COVID-19 Pandemic
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
COVID-19
Pregnancy Complications
Eligibility:
FEMALE
Brief 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 ...
Detailed Description
This cohort study includes women who deliver at one of the MFMU Network hospitals on randomly selected days between March 1 and December 31, 2019 and March 1 and December 31, 2020 to evaluate the effe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Multifetal gestation higher than twins
Key Trial Info
Start Date :
June 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 4 2021
Estimated Enrollment :
25604 Patients enrolled
Trial Details
Trial ID
NCT04519502
Start Date
June 23 2020
End Date
November 4 2021
Last Update
March 27 2023
Active Locations (12)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Columbia University-St. Luke's Hospital
New York, New York, United States, 10032
4
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 17599