dbGaP Study Accession: phs002905

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/geyp-w645

Release Date: 08/30/2023

Study Description: Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk of preterm birth, cesarean section, and maternal intensive care. The objectives of this study were to: (a) evaluate the full impact of SARS-CoV-2 in pregnancy to inform testing strategies, (b) examine the factors that impede testing during pregnancy, and (c) use study data to devise implementation strategies that improve SARS-CoV-2 testing in pregnancy and prenatal care during the pandemic. To do so, this study proposed to prospectively enroll two cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2 antibodies crossed over to the exposed cohort. In total, an estimated 179 pregnant women were followed per cohort. In Aim 1, the study evaluated patients' and providers' perceptions of SARS-CoV-2 testing during pregnancy and the influence of COVID-19 on maternal care-seeking behavior and anxiety via surveys and semi-structured interviews. The study hypothesized suboptimal uptake of testing among pregnant women due to the fear of repercussions from a positive test. In Aim 2, the study determined the effect of SARS-CoV-2 infection during pregnancy on the risk of preterm birth and other adverse pregnancy outcomes in symptomatic and asymptomatic disease. The study hypothesized that SARS-CoV-2 infection will increase the risk of preterm birth by 12%, regardless of disease severity. In Aim 3, the study estimated the risk of mother-to-fetus SARS-CoV-2 transmission and viral presence in umbilical cord blood, placenta, and amniotic fluid by assaying for viral RNA in the neonate, cord blood, and placenta. The study hypothesized that SARS-CoV-2 can be transmitted from mother to fetus. Collectively, Aims 1-3 were interpreted by investigators, a Scientific Advisory Board (experts in obstetrics, infectious disease, implementation science, disparities) and Community Advisory Board (an obstetric social worker, pregnant women, and a director of a community obstetrics clinic) who applied data to devising targeted implementation strategies designed for rapid community dissemination to improve testing and prenatal care. In sum, this study filled knowledge gaps on the impact of SARS-CoV-2 infection and current utilization of diagnostic testing in pregnancy. Further, it created implementation strategies to overcome barriers to testing, increase uptake, and promote acceptance and sustainability of testing. Lastly, this study helped determine optimal testing strategies by examining the necessity of testing for asymptomatic disease, informed prenatal care plans by assessing the full impact of infection, and contributed to the ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.

Updated Date: 04/17/2024

Principal Investigator: Foeller, Megan

Has Data Files: Yes

Study Domain: Testing Rate/Uptake; Mental Health; Pandemic Perceptions and Decision-Making; Health Behaviors; Serological (Antibody) Testing

Data Collection Method: Survey; Interview or Focus Group

Keywords: Asymptomatic Population; Individual-Level Data; Testing in Pregnancy and Prenatal Care; Mother-to-fetus SARS-CoV-2 Transmission; Symptomatic Population

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: Barnes Jewish Hospital; Mercy Hospital St. Louis

Data Types: Imaging; Other; Social; Questionnaires/Surveys; Psychological; Behavioral; Electronic Medical Records; Clinical

Data Types, Other: Biologic specimens: umbilical cord blood, placental tissue, and amniotic fluid

Study Start Date: 11/01/2020

Study End Date: 10/31/2022

Species: Human Data

Estimated Cohort Size: 420

Study Population Focus: Pregnant (or Nursing) Women; Adults

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35970470/; https://pubmed.ncbi.nlm.nih.gov/35523141/; https://pubmed.ncbi.nlm.nih.gov/34809458/; https://pubmed.ncbi.nlm.nih.gov/34171317/; https://pubmed.ncbi.nlm.nih.gov/33870242/

Acknowledgement Statement: This study was supported through funding, 3R01HD091218-04S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We would also like to acknowledge the many patients and staff from Washington University, Mercy Hospital, and the St. Louis community who contributed their time to this project. Approved users should acknowledge the provision of data access by dbGaP for accession phs002905.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-135

NIH Grant or Contract Number(s): 3R01HD091218-04S1

Consent/Data Use Limitations: General Research Use