Rapid establishment of a COVID-19 perinatal biorepository: early lessons from the first 100 women enrolled.

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.

Wireless Vital Sign Monitoring in Pregnant Women: A Functionality and Acceptability Study.

OBJECTIVE: To test the functionality and acceptability of a wireless vital sign monitor in an inpatient obstetric unit. MATERIALS AND METHODS: Pregnant women at a U.S. tertiary-care hospital wore a wireless vital sign sensor that captures heart rate, respiratory rate, and temperature. Measurements were compared with vital signs obtained by standard devices. We defined continuous capture of vital signs for 30 min with wireless data transfer to a central monitor as functional success. Acceptability was assessed per the pregnant women and nurses observing the device. Bland-Altman plots were constructed to assess agreement between the wireless sensor and standard measurements. RESULTS: Thirty of 32 enrolled pregnant women had successful monitoring; 2 cases were stopped early for non-study-related reasons. Comparing wireless sensor and standard measurements, the mean difference (limits of agreement) values at the 25th and 75th percentiles were 1.6 (±13.2) and 4.2 (±18.6) heartbeats/min, 4.2 (±6.1) and 0.7 (±5.4) respirations/min, and 0.02°C (±1.5) and 0.5°C (±1.8), respectively. Most pregnant women found the device comfortable, likeable, and useful (78%, 81%, and 97%, respectively); 80% of nurses found the monitor easy to use, and 84% would recommend it to a patient. CONCLUSIONS: We successfully obtained maternal vital signs using a simple wireless monitor with high acceptability. Well-validated monitors of this nature could significantly alleviate the human resource burden of monitoring during labor and confer greatly desired mobility to laboring pregnant women, although incorporation of blood pressure monitoring will be critical.

Wireless fetal heart rate monitoring in inpatient full-term pregnant women: testing functionality and acceptability.

We tested functionality and acceptability of a wireless fetal monitoring prototype technology in pregnant women in an inpatient labor unit in the United States. Women with full-term singleton pregnancies and no evidence of active labor were asked to wear the prototype technology for 30 minutes. We assessed functionality by evaluating the ability to successfully monitor the fetal heartbeat for 30 minutes, transmit this data to Cloud storage and view the data on a web portal. Three obstetricians also rated fetal cardiotocographs on ease of readability. We assessed acceptability by administering closed and open-ended questions on perceived utility and likeability to pregnant women and clinicians interacting with the prototype technology. Thirty-two women were enrolled, 28 of whom (87.5%) successfully completed 30 minutes of fetal monitoring including transmission of cardiotocographs to the web portal. Four sessions though completed, were not successfully uploaded to the Cloud storage. Six non-study clinicians interacted with the prototype technology. The primary technical problem observed was a delay in data transmission between the prototype and the web portal, which ranged from 2 to 209 minutes. Delays were ascribed to Wi-Fi connectivity problems. Recorded cardiotocographs received a mean score of 4.2/5 (± 1.0) on ease of readability with an interclass correlation of 0.81(95%CI 0.45, 0.96). Both pregnant women and clinicians found the prototype technology likable (81.3% and 66.7% respectively), useful (96.9% and 66.7% respectively), and would either use it again or recommend its use to another pregnant woman (77.4% and 66.7% respectively). In this pilot study we found that this wireless fetal monitoring prototype technology has potential for use in a United States inpatient setting but would benefit from some technology changes. We found it to be acceptable to both pregnant women and clinicians. Further research is needed to assess feasibility of using this technology in busy inpatient settings.