Official Title
In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers
Brief Summary

The pregnancy related pro-thrombotic state, in addition to the COVID-19 associated hypercoagulability may have unknown consequences to the developing fetus. Hence, this proposal seeks to address this question that may have important implications for women that contract this virus during gestation.

Detailed Description

Hypercoagulability and increased risk for venous thromboembolism (VTE) in severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infected patients are well documented in the
growing body of literature, leading to institutional recommendations for daily pharmacologic
anticoagulation while hospitalized and after discharge for some. While some of these
hospitalized patients with COVID-19 infections have included pregnant women that also require
inpatient pharmacologic anticoagulation and occasionally extended anticoagulation after
discharge, little is known about the effects of the hypercoagulable COVID-19 induced state on
the developing embryo, nor the necessary anticoagulation recommendation guidelines for these
expecting mothers.

The pregnancy related pro-thrombotic state, in addition to the COVID-19 associated
hypercoagulability may have unknown consequences to the developing fetus. Hence, this
proposal seeks to address this question that may have important implications for women that
contract this virus during gestation through the following specific aims.

Specific Aim 1: To evaluate evidence for in-utero vascular accidents that may manifest as
intestinal atresias and limb abnormalities in the first 30 days of life as well as rates of
preterm labor, fetal growth restriction and spontaneous abortions in pregnant females that
contract the SARS-CoV-2 virus during gestation.

Rationale: Pregnancy produces a hypercoagulable state, this study intends to expand on the
body of literature for COVID-19 manifestations by evaluating the additional virus-induced
hypercoagulability on the developing embryo.

Methods: A multidisciplinary approach in conjunction with maternal fetal medicine (MFM),
neonatology, and pathology, the study will identify, and recruit infants whom were exposed to
COVID-19 while in-utereo. This project will run in parallel with the institution's COVID-19
in Pregnancy Biobank that intends to obtain needed epidemiological and clinical data linked
to biosamples to provide insight into SARS-CoV-2 in pregnant women and their infants.

Specific Aim 2: To evaluate children identified in the neonatal intensive care unit (NICU) as
having evidence of intestinal atresias or limb anomalies for potential asymptomatic carriers
of COVID-19 that could have contracted the disease during the pregnancy.

Rationale: As high as 81% of patients that contract SARS-CoV-2 are asymptomatic or minimally
symptomatic during the infection period. The long-term manifestation of the virus in these
asymptomatic carriers, especially in pregnant women and their developing embryos, are
presently unknown.

Methods: Mothers of children identified will undergo SARS-CoV-2 antibody testing to identify
the possibility of asymptomatic carriers which may have occurred during the pregnancy.

Completed
Pregnancy Related
COVID
Intestinal Atresia
Limb Anomaly
Eligibility Criteria

Inclusion Criteria:

- Pregnant females, 18 years and higher, with documented COVID-19 infection (antigen,
PRC, or antibodies in a biologic sample) during gestation who received medical care at
the University of Colorado Hospital (UCH) or Children's Hospital Colorado (CHCO)

- Neonates born to COVID-19 infected mothers

- Neonates ages 1-60 days of life with documented limb anomalies and intestinal atresias

Exclusion Criteria:

- Mothers with a history of vasoactive drug usage during pregnancy

- Mothers taking known teratogens during pregnancy

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Children's Hospital Colorado
Aurora, Colorado, United States

University of Colorado, Denver
NCT Number
MeSH Terms
Intestinal Atresia