Maternal Morbidity and Mortality During the COVID-19 Pandemic

COVID-19 Clinical Trial

— MFMU COVID-19  

Official title:

Maternal Morbidity and Mortality During the COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519502
• Other study ID #: HD36801 - MFMU COVID-19
• Secondary ID: U01HD036801
• Status: Completed
• Start date: June 23, 2020
• Est. completion date: November 4, 2021

Study information

• Verified date: March 2023
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25604
• Est. completion date: November 4, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pregnancy Complications

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Texas - Houston	Houston	Texas
United States	Columbia University-St. Luke's Hospital	New York	New York
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 Utah Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cesarean Delivery	Percentage of patients that had cesarean delivery	Delivery
Secondary	Severe maternal morbidity or mortality	Percentage of patients with at least one of teh following: death, ICU admission, transfusion of 4 or more units of packed red blood cells	During pregnancy through 6 weeks postpartum
Secondary	Adverse maternal outcomes	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	During pregnancy through 6 weeks postpartum
Secondary	Adverse neonatal outcomes	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	Delivery through hospital discharge up to 120 days
Secondary	Neonatal infection	Percentage of neonates with infection diagnosed within delivery hospitalization	Delivery through hospital discharge up to 120 days
Secondary	Maternal in-patient hospitalization days	Number of maternal in-patient hospitalization days	During pregnancy through 6 weeks postpartum
Secondary	Maternal ICU admission	Percentage of patients admitted to the ICU	During pregnancy through 6 weeks postpartum
Secondary	Duration of labor and delivery	Length of time on labor and delivery from admission to delivery for the delivery hospitalization	During pregnancy through delivery
Secondary	Neonatal length of stay	Length of time from delivery to hospital discharge	Delivery through hospital discharge up to 120 days
Secondary	Neonatal ICU length of stay	Length of time from neonatal ICU admission to hospital discharge	Delivery through hospital discharge up to 120 days