Maternal Morbidity and Mortality During the COVID-19 Pandemic
MFMU COVID-19
2 other identifiers
observational
25,604
1 country
12
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2020
CompletedFirst Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2021
CompletedMarch 27, 2023
March 1, 2023
1.2 years
August 18, 2020
March 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Maternal Mortality and Morbidity Composite
Percentage of patients with at least one of the following: mortality, morbidity related to hypertensive disorders of pregnancy, morbidity related to postpartum hemorrhage, morbidity related to infection
During pregnancy through 6 weeks postpartum
Secondary Outcomes (10)
Cesarean Delivery
Delivery
Severe maternal morbidity or mortality
During pregnancy through 6 weeks postpartum
Adverse maternal outcomes
During pregnancy through 6 weeks postpartum
Adverse neonatal outcomes
Delivery through hospital discharge up to 120 days
Neonatal infection
Delivery through hospital discharge up to 120 days
- +5 more secondary outcomes
Study Arms (3)
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.
Eligibility Criteria
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Alabama - Birmingham
Birmingham, Alabama, 35233, United States
Northwestern University
Chicago, Illinois, 60611, United States
Columbia University-St. Luke's Hospital
New York, New York, 10032, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 17599, United States
Case Western Reserve University
Cleveland, Ohio, 44109, United States
Ohio State University
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Brown Univeristy
Providence, Rhode Island, 02905, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Texas - Houston
Houston, Texas, 77030, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 36357949DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Monica Longo, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- STUDY CHAIR
Torri Metz, MD
University of Utah Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 19, 2020
Study Start
June 23, 2020
Primary Completion
August 31, 2021
Study Completion
November 4, 2021
Last Updated
March 27, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Data will be shared per NIH policy.