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

NCT04431869 | Completed

• 1 other identifier: 20-1399
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; COVID; Intestinal Atresia; Limb Anomaly

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Mothers with a history of vasoactive drug usage during pregnancy
• Mothers taking known teratogens during pregnancy

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

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.

MeSH Terms

Conditions

Intestinal Atresia

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: August 18, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)