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

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ClinicalTrials.gov Identifier: NCT04431869
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease
Pregnancy Related COVID Intestinal Atresia Limb Anomaly

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: In-Utero Vascular Accidents in Neonates From COVID-19 Infected Mothers
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Groups and Cohorts
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Group/Cohort
Mothers that contract SARS-CoV-2 during pregnancy

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.

A multidisciplinary approach in conjunction with maternal fetal medicine (MFM), neonatology, and pathology 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. This study will request access to enrolled women infected during gestation and their neonates to assess for the conditions suggestive of in-utero vascular accidents such as intestinal atresias or limb anomalies.
Infants noted to have intestinal atresias or limb anomalies

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.

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.


Outcome Measures
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Primary Outcome Measures :
  1. Rates of intestinal atresias and limb abnormalities [ Time Frame: 12 months ]
    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

  2. Rates of preterm labor, fetal growth restriction and spontaneous abortions [ Time Frame: 12 months ]
    Rates of preterm labor, fetal growth restriction and spontaneous abortions for women that are known to be infected with SARS-CoV-2 during gestation

  3. Rates of maternal SARS-CoV-2 infection among mothers to infants born with intestinal atresias or limb anomalies [ Time Frame: 12 months ]
    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


Biospecimen Retention:   Samples With DNA
Mothers of children enrolled in the study with intestinal atresias or limb anomalies will undergo SARS-CoV-2 antibody testing to identify the possibility of asymptomatic carriers which may have occurred during the pregnancy.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431869


Contacts
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Contact: Jose L Diaz-Miron, MD 7207777600 jose.diaz-miron@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jose L Diaz-Miron, MD    720-777-6571    jose.diaz-miron@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04431869    
Other Study ID Numbers: 20-1399
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This study seeks to find a correlation between maternal COVID-19 infection and in-utero vascular accidents affecting the developing fetus. The knowledge gained from this multidisciplinary study may serve as the foundation for larger epidemiological studies that may query the longitudinal effects of this infection in mothers who contract the disease during pregnancy, as well as for their neonates. On a larger scale, if the study hypothesis is supported by the data, this may provide the foundation for future anticoagulation guidelines that may be enacted on certain women during gestation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Atresia
Digestive System Abnormalities
Digestive System Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities