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Rapid establishment of a COVID-19 perinatal biorepository: early lessons from the first 100 women enrolled.
BMC Med Res Methodol. 2020 08 26; 20(1):215.BM

Abstract

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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Authors+Show Affiliations

Shook LL
Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. lshook@mgh.harvard.edu.
Shui JE
Division of Neonatology and Newborn Medicine, Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.
Boatin AA
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Devane S
Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.
Croul N
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Yonker LM
Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.
Matute JD
Division of Neonatology and Newborn Medicine, Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.
Lima RS
Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.
Schwinn M
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Cvrk D
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Gardner L
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Azevedo R
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Stanton S
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Bordt EA
Department of Pediatrics, Lurie Center for Autism, Massachusetts General Hospital, Boston, MA, USA.
Yockey LJ
Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA. Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.
Fasano A
Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.
Li JZ
Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Yu XG
Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. Ragon Institute of the Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University, Cambridge, MA, USA.
Kaimal AJ
Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Lerou PH
Division of Neonatology and Newborn Medicine, Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.
Edlow AG
Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Biology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA, USA.

MeSH

AdultBetacoronavirusCOVID-19Coronavirus InfectionsFemaleHumansInfant, NewbornPandemicsPatient ParticipationPatient SelectionPerinatal CarePneumonia, ViralPregnancyPregnancy Complications, InfectiousSARS-CoV-2Specimen Handling

Pub Type(s)

Journal Article
Observational Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32842979

Citation

Shook, Lydia L., et al. "Rapid Establishment of a COVID-19 Perinatal Biorepository: Early Lessons From the First 100 Women Enrolled." BMC Medical Research Methodology, vol. 20, no. 1, 2020, p. 215.
Shook LL, Shui JE, Boatin AA, et al. Rapid establishment of a COVID-19 perinatal biorepository: early lessons from the first 100 women enrolled. BMC Med Res Methodol. 2020;20(1):215.
Shook, L. L., Shui, J. E., Boatin, A. A., Devane, S., Croul, N., Yonker, L. M., Matute, J. D., Lima, R. S., Schwinn, M., Cvrk, D., Gardner, L., Azevedo, R., Stanton, S., Bordt, E. A., Yockey, L. J., Fasano, A., Li, J. Z., Yu, X. G., Kaimal, A. J., ... Edlow, A. G. (2020). Rapid establishment of a COVID-19 perinatal biorepository: early lessons from the first 100 women enrolled. BMC Medical Research Methodology, 20(1), 215. https://doi.org/10.1186/s12874-020-01102-y
Shook LL, et al. Rapid Establishment of a COVID-19 Perinatal Biorepository: Early Lessons From the First 100 Women Enrolled. BMC Med Res Methodol. 2020 08 26;20(1):215. PubMed PMID: 32842979.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rapid establishment of a COVID-19 perinatal biorepository: early lessons from the first 100 women enrolled. AU - Shook,Lydia L, AU - Shui,Jessica E, AU - Boatin,Adeline A, AU - Devane,Samantha, AU - Croul,Natalie, AU - Yonker,Lael M, AU - Matute,Juan D, AU - Lima,Rosiane S, AU - Schwinn,Muriel, AU - Cvrk,Dana, AU - Gardner,Laurel, AU - Azevedo,Robin, AU - Stanton,Suzanne, AU - Bordt,Evan A, AU - Yockey,Laura J, AU - Fasano,Alessio, AU - Li,Jonathan Z, AU - Yu,Xu G, AU - Kaimal,Anjali J, AU - Lerou,Paul H, AU - Edlow,Andrea G, Y1 - 2020/08/26/ PY - 2020/07/07/received PY - 2020/08/13/accepted PY - 2020/8/27/entrez PY - 2020/8/28/pubmed PY - 2020/9/4/medline KW - Biobank KW - COVID-19 KW - Immune KW - Neonatology KW - Newborn KW - Obstetrics KW - Pandemic KW - Pregnancy KW - Repository KW - SARS-CoV-2 KW - Vertical transmission SP - 215 EP - 215 JF - BMC medical research methodology JO - BMC Med Res Methodol VL - 20 IS - 1 N2 - 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. SN - 1471-2288 UR - https://www.unboundmedicine.com/medline/citation/32842979/Rapid_establishment_of_a_COVID_19_perinatal_biorepository:_early_lessons_from_the_first_100_women_enrolled_ DB - PRIME DP - Unbound Medicine ER -