In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers

Pregnancy Related Clinical Trial

Official title:

In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431869
• Other study ID #: 20-1399
• Status: Completed
• Start date: August 18, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Intestinal Atresia
• Limb Anomaly
• Pregnancy Related

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of intestinal atresias and limb abnormalities	Evaluate rates of intestinal atresias and limb anomalies in neonates born to women that contract SARS-CoV-2 during pregnancy in the first 30 days of life	12 months
Primary	Rates of preterm labor, fetal growth restriction and spontaneous abortions	Rates of preterm labor, fetal growth restriction and spontaneous abortions for women that are known to be infected with SARS-CoV-2 during gestation	12 months
Primary	Rates of maternal SARS-CoV-2 infection among mothers to infants born with intestinal atresias or limb anomalies	For neonates identified in the NICU with intestinal atresias and limb anomalies, we will test the mothers for the presence of SARS-CoV-2 antibodies that may represent an asymptomatic carrier during gestation	12 months