key: cord-0855595-897gkg10
authors: Raghuraman, Nandini; Hardy, Cassandra; Frolova, Antonina; Kelly, Jeannie C; England, Sarah K; Cahill, Alison G; Carter, Ebony B
title: Impact of the COVID-19 Pandemic on Labor & Delivery Research Operations
date: 2021-07-24
journal: Am J Obstet Gynecol MFM
DOI: 10.1016/j.ajogmf.2021.100443
sha: cb571e961a629ff3b7fa763b45a7a43e1b1b8b08
doc_id: 855595
cord_uid: 897gkg10

OBJECTIVE: Many research studies in the United States came to an abrupt halt when the World Health Organization declared the Coronavirus 2019 (COVID-19) pandemic in March 2020, including ongoing perinatal studies addressing national rates of maternal and fetal morbidity. Research on Labor & Delivery units (L&D) was particularly vulnerable to setbacks due to universal COVID-19 testing policies and asymptomatic infection rates almost 16 times higher than that of other surgical units.(1) We evaluated the impact of the COVID-19 pandemic on L&D research operations and recruitment at a single center. STUDY DESIGN: This cross-sectional study, performed at a tertiary care academic center, evaluated temporal trends in research recruitment among women admitted for labor or induction of labor at ≥37 weeks gestation. This study was IRB exempt. Onsite research recruitment was paused on March 16, 2020 with phased resumption starting July 6, 2020. By August 6, 2020, all L&D studies resumed recruitment. Universal COVID-19 testing on L&D started in May 2020. Upon resuming recruitment, only patients with negative COVID-19 tests were approached by research staff. Patients with pending COVID-19 results at time of active labor or those who declined COVID-19 tests were not approached. We calculated approach rates as the number of women approached for enrollment among all women admitted for delivery and consent rates as the number of women who consented for participation in at least one study among those admitted for delivery. Univariate analyses were used to compare the approach and consent rates pre-research pause (November 2019-March 2020) to the rates post-pause (August-December 2020). A single approach process was used for all studies both pre- and post- research pause. RESULTS: Four studies (3 randomized trials and 1 prospective cohort study) recruited patients pre-research pause. Post-pause, the same four studies resumed recruitment and 2 additional studies (1 randimized trial and 1 prospective cohort study) intiated recruitment. The inclusion criteria for all six studies was singleton pregnancies admitted for spontaneous labor or induction of labor at ≥37 weeks gestation. More than 75% of the principal investigators for all studies were trainees or pretenure faculty. The number of research staff was the same pre- and post-pause. There were 1213 and 1219 deliveries in the pre- and post-periods respectively, with no differences in patient demographics between periods. The majority of patients who delivered in both periods were Black (53.3% pre vs 52.5% post, p=0.50). The COVID-19 positivity rate was 5% during and after the research pause.There was a lower proportion of women approached for enrollment in the post period (46.1% vs 33.8%, p<0.001). The proportion of women admitted for delivery who consented to research decreased from 35.1% to 24.0% (p<0.001), although the number of women who agreed to participate among all those approached for enrollment remained stable (74.8% vs 71.2%, p=0.08) Figure. In order to investigate whether the changes in approach and consent rates were related to the pandemic and not a consequence of normal seasonal or temporal trends in research recruitment, we assessed approach and consent rates in the two years preceding the pandemic (2017-2019) and found consistent approach and consent rates throughout the year, suggesting minimal seasonal changes in research recruitment. CONCLUSION: The pandemic poses a threat to L&D research recruitment. Despite stable delivery volume and research staff capacity, fewer patients were approached and consented for research participation during the pandemic. These results are likely explained by COVID-19 status and testing protocols as patients with pending, unknown, or positive COVID-19 tests were not approached. An alternate consideration for lower approach rates during the pandemic is research staff apprehension. Decreased research participation during the pandemic is less likely to be attributed to patient apprehension, as the proportion of women who consented among those approached remained stable.

Research on Labor & Delivery units (L&D) was particularly vulnerable to setbacks due to universal COVID-19 testing policies and asymptomatic infection rates almost 16 times higher than that of other surgical units. 1 We evaluated the impact of the COVID-19 pandemic on L&D research operations and recruitment at a single center.

This cross-sectional study, performed at a tertiary care academic center, evaluated temporal trends in research recruitment among women admitted for labor or induction of labor at ≥37 weeks gestation. This study was IRB exempt. Onsite research recruitment was paused on March 16, 2020 with phased resumption starting July 6, 2020. By August 6, 2020, all L&D studies resumed recruitment. Universal COVID-19 testing on L&D started in May 2020. approached. An alternate consideration for lower approach rates during the pandemic is research staff apprehension. Decreased research participation during the pandemic is less likely to be attributed to patient apprehension, as the proportion of women who consented among those approached remained stable.

In addition to impact on scientific advancement, these results have implications for research conducted by trainees and junior faculty and speak to broader initiatives to address disruptions to tenure clocks and graduation requirements. Potential techniques for maintaining research integrity and productivity include virtual consent platforms and post hoc analyses accounting for recruitment disruption. [2] [3] [4] If innovative approaches to research processes are not adequately addressed, we may observe a protracted shift in research recruitment rates, delay in evidence-based recommendations, and altered career trajectories for junior investigators. All scenarios pose barriers for critical national initiatives to reduce maternal morbidity and mortality.

Preprocedural asymptomatic coronavirus disease 2019 cases in obstetrical and surgical units

Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity

Conducting Clinical Research in the Era of Covid-19

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards