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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04519502
Recruitment Status : Completed
First Posted : August 19, 2020
Last Update Posted : June 15, 2022
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

Tracking Information
First Submitted Date August 18, 2020
First Posted Date August 19, 2020
Last Update Posted Date June 15, 2022
Actual Study Start Date June 23, 2020
Actual Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 18, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2020)
  • Cesarean Delivery [ Time Frame: Delivery ]
    Percentage of patients that had cesarean delivery
  • 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
  • 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
  • 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
  • Neonatal infection [ Time Frame: Delivery through hospital discharge up to 120 days ]
    Percentage of neonates with infection diagnosed within delivery hospitalization
  • Maternal in-patient hospitalization days [ Time Frame: During pregnancy through 6 weeks postpartum ]
    Number of maternal in-patient hospitalization days
  • Maternal ICU admission [ Time Frame: During pregnancy through 6 weeks postpartum ]
    Percentage of patients admitted to the ICU
  • 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
  • Neonatal length of stay [ Time Frame: Delivery through hospital discharge up to 120 days ]
    Length of time from delivery to hospital discharge
  • 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
Original Secondary Outcome Measures
 (submitted: August 18, 2020)
  • Cesarean Delivery [ Time Frame: Delivery ]
    Percentage of patients that had cesarean delivery
  • 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
  • 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
  • Adverse neonatal outcomes [ Time Frame: Delivery through hospital discharge up to 52 weeks ]
    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
  • Neonatal infection [ Time Frame: Delivery through hospital discharge up to 52 weeks ]
    Percentage of neonates with infection diagnosed within delivery hospitalization
  • Maternal in-patient hospitalization days [ Time Frame: During pregnancy through 6 weeks postpartum ]
    Number of maternal in-patient hospitalization days
  • Maternal ICU admission [ Time Frame: During pregnancy through 6 weeks postpartum ]
    Percentage of patients admitted to the ICU
  • Duration of labor and delivery [ Time Frame: Delivery through hospital discharge up to 52 weeks ]
    Length of time on labor and delivery from admission to delivery for the delivery hospitalization
  • Neonatal length of stay [ Time Frame: Delivery through hospital discharge up to 52 weeks ]
    Length of time from delivery to hospital discharge
  • Neonatal ICU length of stay [ Time Frame: Delivery through hospital discharge up to 52 weeks ]
    Length of time from neonatal ICU admission to hospital discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal Morbidity and Mortality During the COVID-19 Pandemic
Official Title Maternal Morbidity and Mortality During the COVID-19 Pandemic
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • COVID-19
  • Pregnancy Complications
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 3, 2022)
25604
Original Estimated Enrollment
 (submitted: August 18, 2020)
26400
Actual Study Completion Date November 4, 2021
Actual Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04519502
Other Study ID Numbers HD36801 - MFMU COVID-19
U01HD036801 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data will be shared per NIH policy.
Supporting Materials: Study Protocol
Current Responsible Party The George Washington University Biostatistics Center
Original Responsible Party Same as current
Current Study Sponsor The George Washington University Biostatistics Center
Original Study Sponsor Same as current
Collaborators Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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
PRS Account The George Washington University Biostatistics Center
Verification Date June 2022