Journal
BMC MEDICAL RESEARCH METHODOLOGY
Volume 20, Issue 1, Pages -Publisher
BMC
DOI: 10.1186/s12874-020-01102-y
Keywords
SARS-CoV-2; COVID-19; Pandemic; Biobank; Repository; Pregnancy; Newborn; Vertical transmission; Immune; Obstetrics; Neonatology
Categories
Funding
- National Institute of Child Health and Human Development [1R01HD100022-01, K23 HD097300-01]
- National Institute of Diabetes and Digestive and Kidney Diseases [5P30DK040561-23]
- National Heart Lung and Blood Institute [K08HL143183]
- National Institute of Allergy and Infectious Diseases [U01AI106701]
- Cystic Fibrosis Foundation [YONKER18Q0]
- Mark and Lisa Schwartz
- Massachusetts General Hospital Executive Committee on Research through the Center for Diversity and Inclusion
- Claflin Distinguished Award from Massachusetts General Hospital Executive Committee on Research
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Background Collection of biospecimens is a critical first step to understanding the impact of COVID-19 on pregnant women and newborns - vulnerable populations that are challenging to enroll and at risk of exclusion from research. We describe the establishment of a COVID-19 perinatal biorepository, the unique challenges imposed by the COVID-19 pandemic, and strategies used to overcome them. Methods A transdisciplinary approach was developed to maximize the enrollment of pregnant women and their newborns into a COVID-19 prospective cohort and tissue biorepository, established on March 19, 2020 at Massachusetts General Hospital (MGH). The first SARS-CoV-2 positive pregnant woman was enrolled on April 2, and enrollment was expanded to SARS-CoV-2 negative controls on April 20. A unified enrollment strategy with a single consent process for pregnant women and newborns was implemented on May 4. SARS-CoV-2 status was determined by viral detection on RT-PCR of a nasopharyngeal swab. Wide-ranging and pregnancy-specific samples were collected from maternal participants during pregnancy and postpartum. Newborn samples were collected during the initial hospitalization. Results Between April 2 and June 9, 100 women and 78 newborns were enrolled in the MGH COVID-19 biorepository. The rate of dyad enrollment and number of samples collected per woman significantly increased after changes to enrollment strategy (from 5 to over 8 dyads/week,P < 0.0001, and from 7 to 9 samples,P < 0.01). The number of samples collected per woman was higher in SARS-CoV-2 negative than positive women (9 vs 7 samples,P = 0.0007). The highest sample yield was for placenta (96%), umbilical cord blood (93%), urine (99%), and maternal blood (91%). The lowest-yield sample types were maternal stool (30%) and breastmilk (22%). Of the 61 delivered women who also enrolled their newborns, fewer women agreed to neonatal blood compared to cord blood (39 vs 58,P < 0.0001). Conclusions Establishing a COVID-19 perinatal biorepository required patient advocacy, transdisciplinary collaboration and creative solutions to unique challenges. This biorepository is unique in its comprehensive sample collection and the inclusion of a control population. It serves as an important resource for research into the impact of COVID-19 on pregnant women and newborns and provides lessons for future biorepository efforts.
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