Clinical trial NCT04431869: In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers
Official title: In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
COVID
Intestinal Atresia
Limb Anomaly
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females with documented COVID-19 gestational infections and their infants will be enrolled. Additionally, neonates with limb anomalies and intestinal atresias will be identified in the NICU and both infant and mother enrolled to identify if maternal SARS-CoV-2 infection occurred during the pregnancy.

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.

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

Primary outcomes:
measure: Rates of intestinal atresias and limb abnormalities
timeFrame: 12 months
measure: Rates of preterm labor, fetal growth restriction and spontaneous abortions
timeFrame: 12 months
measure: Rates of maternal SARS-CoV-2 infection among mothers to infants born with intestinal atresias or limb anomalies
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: