Characteristics of COVID-19 Infection Among PREGnant Women

TITLE: Characteristics of COVID-19 infection in pregnant women (CCOVID-PREG)

Background Coronavirus disease 2019 (COVID-19) is an infectious disease characterized by
severe respiratory illness which can lead to multi-organ damage. It was reported in December
2019 in China, and was declared as a pandemic on March 11, 2020. The number of cases quickly
increased in the USA since March; as of May 5th the total number of cases was 1'171,510 with
68,279 deaths.

COVID-19 is mainly spread through respiratory droplets of infected persons. While most
respiratory viruses are more infectious when a patient is symptomatic, viral, epidemiology
and modeling evidence suggest that also pre-symptomatic and asymptomatic individuals are able
to transmit the infection. This information has implications on how resources can be spent on
public interventions to prevent spreading of the virus. It also can help guide further
management of pregnant women before, at, and after delivery.

Despite a recent publication reporting near 20% rate of positive COVID-19 tests in all
pregnant women with a 13% rate of asymptomatic patients admitted to Labor and Delivery, the
Society for Maternal Fetal Medicine and the Center for Disease Control and Prevention (CDC)
still recommend not prioritizing testing of patients who are asymptomatic. Meanwhile, the
American College of Obstetricians and Gynecologists published a recent Practice Advisory that
encouraged prioritization of symptomatic patients but also acknowledges the potential impact
of asymptomatic patients.

Racial disparities have been reported among non-pregnant adults infected with COVID-19. Lower
income communities in New York City have a higher rate of infection, with Black and Hispanic
communities found to be twice more likely to die from the infection as compared to
Caucasians. Hispanic individuals are 1.7 more likely to get infected compared to their
non-Hispanic peers. As many individuals in these communities are essential workers such as
city employees and service personnel, many are undocumented; this is why public health
interventions such as home isolation, social distancing, and early testing might not be
applicable to these populations.

Inova Fairfax Hospital along with other hospitals from the Inova Health System (IHS) is
located in the Washington District of Columbia (DC)-Northern Virginia-Maryland area in the
east coast of the USA. Our hospitals provide obstetric care including anterpartum management,
surgeries and delivery to a vast number of patients with private insurance as well as those
uninsured from charity clinics in Northern Virginia. To minimize the risk of inadvertent
exposure of non-infected pregnant women and health care personnel to COVID-19 positive
asymptomatic patients, on April 25, 2020 IHS hospitals started testing for COVID-19 all
pregnant women admitted to Labor and Delivery and Antepartum units. In our institution, the
authors aim to investigate:

- Rate of COVID-19 positive pregnant women

- Prevalence of COVID-19 positive symptomatic and asymptomatic pregnant women admitted to
obstetric services

- Demographic profile of COVID-19 positive asymptomatic pregnant women

- Clinical outcomes of COVID-19 positive symptomatic and asymptomatic women

- Rate of COVID-19 positive newborns from infected mothers

- Rate and profile of COVID-19 infected pregnant women who require respiratory support in
comparison to those affected by other respiratory infections

Study design and participants This is an observational chart review study. Clinical records
and compiled data of all hospitalized and outpatient pregnant women with laboratory-confirmed
COVID-19 from March 18, 2020 to March 17, 2021 from IHS hospitals will be included in a
database. COVID-19 is diagnosed on the basis of the CDC definition.[12] A confirmed case of
COVID-19 is defined as a positive result on real-time
reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal-pharyngeal swab
specimens.[13] Data on recent exposure history, presence or absence of clinical symptoms or
signs, laboratory findings, and maternal and perinatal outcomes will be collected. All
medical records will be sent to the principal investigator at Inova Fairfax Hospital. Data
will be entered into a computerized de-identified database and cross-checked.

Outcomes and Abstracted Data The main outcome of the study is the rate of asymptomatic
pregnant women who test positive for COVID-19 at the time of hospital admission.

Secondary outcomes will be:

- Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission

- Rate of asymptomatic positive pregnant women who later will develop COVID-19 related
symptoms

- Prevalence of COVID-19 positive newborns from infected mothers

- Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ
complications requiring admission to Medicine or Intensive Care units

- Rate of maternal death related to COVID-19 infection

Data to be obtained during chart abstraction will be:

Maternal:

- Demographics: Ethnicity, Age. Type of medical insurance, Preferred mode of
transportation, Job information

- Body mass index

- Clinical indicators of mild disease: Fever, Cough, Abnormal sense of smell or taste,
Shortness of Breath, Diarrhea

- Clinical indicators of moderate disease: Dyspnea, Pneumonia, Refractory Fever

- Clinical indicators of severe clinical course: Admission to intensive care unit (ICU),
Acute Respiratory Distress Syndrome (ARDS), Need for mechanical ventilation, Multi-Organ
Failure, Maternal Mortality

- Abnormal Laboratory Results: Leukopenia, Lymphopenia, Thrombocytopenia, Abnormal liver
enzymes

- Obstetric outcomes: Spontaneous Abortion, Perinatal Mortality, Preterm delivery (PTD),
Fetal growth restriction (FGR), Preeclampsia, Cesarean delivery (CD) Neonatal: Admission
to neonatal intensive care unit (NICU), Rate of newborns testing positive for COVID-19
whose mothers are known COVID-19 infected individuals (symptomatic and asymptomatic),
Vertical transmission, Apgar Scores, Breastfeeding

Statistical analysis The authors will use SAS 9.4 software (SAS Inc, Cary, NC) for our
analyses. Data will be shown as means ± standard deviation (SD), or as medians (range), or as
numbers (percentage).