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Maternal Morbidity and Mortality During the COVID-19 Pandemic (MFMU COVID-19)

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ClinicalTrials.gov Identifier: NCT04519502
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : August 21, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

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.

Condition or disease
COVID-19 Pregnancy Complications

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 effect of a major public health crisis (COVID-19 pandemic) on maternal morbidity and mortality among pregnant and immediately postpartum women. This time period allows for calendar months in 2020 representing the key time period of the pandemic - after testing became available and changes were implemented in healthcare. Inclusion of the same months from 2019 represent the time period prior to the pandemic.

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.

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Study Type : Observational
Estimated Enrollment : 26400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Maternal Morbidity and Mortality During the COVID-19 Pandemic
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
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.



Primary Outcome Measures :
  1. Maternal Mortality and Morbidity Composite [ Time Frame: During pregnancy through 6 weeks postpartum ]
    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


Secondary Outcome Measures :
  1. Cesarean Delivery [ Time Frame: Delivery ]
    Percentage of patients that had cesarean delivery

  2. Severe maternal morbidity or mortality [ Time Frame: During pregnancy through 6 weeks postpartum ]
    Percentage of patients with at least one of teh following: death, ICU admission, transfusion of 4 or more units of packed red blood cells

  3. Adverse maternal outcomes [ Time Frame: During pregnancy through 6 weeks postpartum ]
    a. Percentage of patients with the following outcomes: ICU admission, ventilator support, extracorporeal membrane oxygenation (ECMO), pressor support, cardiomyopathy, venous thromboembolism (deep venous thrombosis or pulmonary embolus), arterial thrombosis including cerebrovascular accident, cerebral venous sinus thrombosis, renal failure requiring dialysis, encephalopathy, superficial or deep incisional surgical site infection, multisystem inflammatory syndrome

  4. Adverse neonatal outcomes [ Time Frame: Delivery through hospital discharge up to 120 days ]
    a. Percentage of neonates with the following outcomes: fetal or neonatal death, preterm birth < 37 weeks gestation, small for gestational age, major congenital malformations, perinatal preterm composite (defined as fetal or neonatal death, severe bronchopulmonary dysplasia, intraventricular hemorrhage grades III-IV, necrotizing enterocolitis, periventricular leukomalacia, retinopathy of prematurity stage III-V, or proven sepsis), perinatal term composite (defined as fetal or neonatal death, respiratory support within first 72 hours, Apgar score <=3 at 5 minutes, hypoxic ischemic encephalopathy, seizure, infection, birth trauma, meconium aspiration syndrome, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support

  5. Neonatal infection [ Time Frame: Delivery through hospital discharge up to 120 days ]
    Percentage of neonates with infection diagnosed within delivery hospitalization

  6. Maternal in-patient hospitalization days [ Time Frame: During pregnancy through 6 weeks postpartum ]
    Number of maternal in-patient hospitalization days

  7. Maternal ICU admission [ Time Frame: During pregnancy through 6 weeks postpartum ]
    Percentage of patients admitted to the ICU

  8. Duration of labor and delivery [ Time Frame: During pregnancy through delivery ]
    Length of time on labor and delivery from admission to delivery for the delivery hospitalization

  9. Neonatal length of stay [ Time Frame: Delivery through hospital discharge up to 120 days ]
    Length of time from delivery to hospital discharge

  10. Neonatal ICU length of stay [ Time Frame: Delivery through hospital discharge up to 120 days ]
    Length of time from neonatal ICU admission to hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

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, 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 Criteria:

  • Multifetal gestation higher than twins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519502


Contacts
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Contact: Rebecca Clifton, PhD 301-881-9260 rclifton@bsc.gwu.edu
Contact: Cora MacPherson, PhD 301-881-9260 coram@bsc.gwu.edu

Locations
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United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Janatha Grant, BSN    205-934-9489    jsgrant@uabmc.edu   
Principal Investigator: Alan T. Tita, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett, RN,BSN, CCRC    312-503-3200    g-mallett@northwestern.edu   
Principal Investigator: William Grobman, MD         
United States, New York
Columbia University-St. Luke's Hospital Recruiting
New York, New York, United States, 10032
Contact: Sabine Bousleiman, RNC MSN    212-305-4348    sb1080@columbia.edu   
Principal Investigator: Cynthia Gyamfi-Bannerman, MD         
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 17599
Contact: Kelly Clark, RN BSN    919-350-6117    kelly_clark@med.unc.edu   
Principal Investigator: John M. Thorp Jr., MD         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44109
Contact: Wendy Dalton, RNC    216-778-7533    WDalton@metrohealth.org   
Principal Investigator: Jennifer Bailit, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Anna Bartholomew, RN,BSN,CCRP    614-685-3229    Anna.Bartholomew@osumc.edu   
Principal Investigator: Maged Costantine, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jennifer Craig, BSN    212-662-3926    jennifer.craig@uphs.upenn.edu   
Principal Investigator: Samuel Parry, MD         
Magee Women's Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Bickus, BS, RN    412-641-4072    mbickus@mail.magee.edu   
Principal Investigator: Hyagriv Simhan, MD, MS         
United States, Rhode Island
Brown Univeristy Recruiting
Providence, Rhode Island, United States, 02905
Contact: Donna Allard, RN    401-274-1122    dallard@wihri.org   
Principal Investigator: Dwight J Rouse, MD         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, MSN    409-772-0312    assalaza@utmb.edu   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN,BSN,CCRC    713-500-6467    Felecia.Ortiz@uth.tmc.edu   
Principal Investigator: Suneet Chauhan, MD         
United States, Utah
University of Utah Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Amber Sowles, RN BSN CORP    801-585-5499    amber.sowles@hsc.utah.edu   
Principal Investigator: Torri Metz, MD         
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Director: Andrew Bremer, MD, PhD, MAS Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Torri Metz, MD University of Utah Medical Center
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Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT04519502    
Other Study ID Numbers: HD36801 - MFMU COVID-19
U01HD036801 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared per NIH policy.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications