Maternal Morbidity and Mortality During the COVID-19 Pandemic
NCT ID: NCT04519502
Last Updated: 2023-03-27
Study Results
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Basic Information
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COMPLETED
25604 participants
OBSERVATIONAL
2020-06-23
2021-11-04
Brief Summary
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Detailed Description
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In addition to the cohort of women delivering at the selected MFMU Network sites on randomly selected days, all pregnant and immediately postpartum (within 6 weeks of delivery) with confirmed COVID-19 infection will be included in this study. Both women who were managed in-patient and those managed out-patient with COVID-19 infection will be included. All pregnant women with confirmed COVID-19 infection between March 1, 2020 and December 31, 2020 will be followed for maternal and neonatal outcomes through 6 weeks after delivery or surgical removal of the pregnancy.
Trained research staff will abstract data from the hospital's electronic medical records that meet eligibility criteria. Measures of healthcare and community-based modifications in response to the pandemic will be recorded by research staff. Individual participant data will include baseline data, COVID-19 exposure data, and maternal and neonatal outcome data.
The three primary objectives are 1) to evaluate whether pregnant or immediately postpartum women experience higher maternal morbidity and mortality during the COVID-19 pandemic than before the pandemic, 2) to evaluate whether women with COVID-19 infection, both in- and out-patient, have higher maternal morbidity and mortality than pregnant women without COVID-19 infection, and 3) to describe maternal and neonatal outcome data for all pregnant and immediately postpartum women with a confirmed COVID infection and contribute these data to an NICHD COVID-19 pregnancy registry. The primary endpoint, maternal morbidity and mortality, is defined as morbidity related to hypertensive disorders of pregnancy, morbidity related to postpartum hemorrhage, or morbidity related to infection during pregnancy or within six weeks (42 days) postpartum. For primary objective 1, the study has more than 90% power to show a 30% increase in the rate of the primary endpoint assuming the rate is at least 3% in calendar year 2019 and an alpha of 0.05 two-sided. For primary objective 2, the study will have more than 85% power to detect a 50% increase in the primary composite maternal morbidity endpoint, from 5% to 7.5% with an alpha=0.05 two sided if only 1,000 confirmed COVID-19 people are enrolled (80% power to detect a 30% increase in the primary composite if 2,200 confirmed COVID-19 people are enrolled).
For objective 1, analyses of the primary endpoint will consist of summarizing the proportions of participants with the primary endpoint for each calendar year cohort and calculating the corresponding relative risks with 95% confidence intervals. Individual morbidity composites (hypertensive disorders, postpartum hemorrhage, and infection) will also be compared by calendar year cohort. Outcome rates within 2019 will be graphically displayed and tested over time to ensure changes are not evident during the year that may explain differences between calendar years 2019 and 2020. For objective 2, analyses of the primary endpoint will consist of summarizing the proportions of participants with the primary endpoint among women with confirmed COVID-19 infection and those without confirmed infection, and calculating the corresponding relative risk with 95% confidence intervals.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The George Washington University Biostatistics Center
OTHER
Responsible Party
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Principal Investigators
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Monica Longo, MD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Torri Metz, MD
Role: STUDY_CHAIR
University of Utah Medical Center
Locations
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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
Countries
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References
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Metz TD, Clifton RG, Hughes BL, Sandoval GJ, Grobman WA, Saade GR, Manuck TA, Longo M, Sowles A, Clark K, Simhan HN, Rouse DJ, Mendez-Figueroa H, Gyamfi-Bannerman C, Bailit JL, Costantine MM, Sehdev HM, Tita ATN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Association Between Giving Birth During the Early Coronavirus Disease 2019 (COVID-19) Pandemic and Serious Maternal Morbidity. Obstet Gynecol. 2023 Jan 1;141(1):109-118. doi: 10.1097/AOG.0000000000004982. Epub 2022 Oct 27.
Other Identifiers
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HD36801 - MFMU COVID-19
Identifier Type: -
Identifier Source: org_study_id
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