A
References
Abduljalil, K., A. Pansari, and M. Jamei. 2020. Prediction of maternal pharmacokinetics using physiologically based pharmacokinetic models: Assessing the impact of the longitudinal changes in the activity of CYP1A2, CYP2D6 and CYP3A4 enzymes during pregnancy. Journal of Pharmacokinetics and Pharmacodynamics 47(4):361-383.
Adam, M. P., J. E. Polifka, and J. M. Friedman. 2011. Evolving knowledge of the teratogenicity of medications in human pregnancy. American Journal of Medical Genetics Part C: Seminars in Medical Genetics 157(3):175-182.
Baird, D. D., D. B. Dunson, M. C. Hill, D. Cousins, and J. M. Schectman. 2003. High cumulative incidence of uterine leiomyoma in Black and White women: Ultrasound evidence. American Journal of Obstetrics and Gynecology 188(1):100-107.
Bianchi, D. W., L. Kaeser, and A. N. Cernich. 2021. Involving pregnant individuals in clinical research on COVID-19 vaccines. JAMA 325(11):1041-1042.
Blehar, M. C., C. Spong, C. Grady, S. F. Goldkind, L. Sahin, and J. A. Clayton. 2013. Enrolling pregnant women: Issues in clinical research. Women’s Health Issues 23(1):e39-e45.
CDC (Centers for Disease Control and Prevention). 2019. Birth defects are common, costly, and critical. https://www.cdc.gov/ncbddd/birthdefects/infographic.html (accessed September 16, 2022).
CDC. 2022. COVID-19 vaccines while pregnant or breastfeeding. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html (accessed September 22, 2022).
DeSisto, C. L., B. Wallace, R. M. Simeone, K. Polen, J. Y. Ko, D. Meaney-Delman, and S. R. Ellington. 2021. Risk for stillbirth among women with and without COVID-19 at delivery hospitalization—United States, March 2020–September 2021. MMWR Morbidity and Mortality Weekly Report 70(47):1640-1645.
Edlow, A. G., V. M. Castro, L. L. Shook, A. J. Kaimal, and R. H. Perlis. 2022. Neurodevelop-mental outcomes at 1 year in infants of mothers who tested positive for SARS-CoV-2 during pregnancy. JAMA Network Open 5(6):e2215787.
FDA (U.S. Food and Drug Administration). 2018. Milestones in U.S. food and drug law. https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law (accessed September 22, 2022).
FDA. 2020. Vaccines and related biological products advisory committee December 17, 2020 meeting presentation—FDA review of efficacy and safety of Moderna COVID-19 vaccine emergency use authorization request. https://www.fda.gov/media/144585/download (accessed September 22, 2022).
Hebert, M. F., T. R. Easterling, B. Kirby, D. B. Carr, M. L. Buchanan, T. Rutherford, K. E. Thummel, D. P. Fishbein, and J. D. Unadkat. 2008. Effects of pregnancy on CYP3A and P-glycoprotein activities as measured by disposition of midazolam and digoxin: A University of Washington specialized center of research study. Clinical Pharmacology and Therapeutics 84(2):248-253.
HHS (U.S. Department of Health and Human Services). 2017. Charter—Task Force on Research Specific to Pregnant Women and Lactating Women. https://www.nichd.nih.gov/sites/default/files/2017-09/PRGLAC_Signed_Charter_201704.pdf (accessed October 10, 2022).
IOM (Institute of Medicine). 1994. Women and health research: Ethical and legal issues of including women in clinical studies, Volume 1. Washington, DC: The National Academies Press.
IOM. 2008. Addressing the barriers to pediatric drug development: Workshop summary. Edited by C. Vanchieri, A. S. Butler and A. Knutsen. Washington, DC: The National Academies Press.
IOM. 2010. Women’s health research: Progress, pitfalls, and promise. Washington, DC: The National Academies Press.
Kendig, S., J. P. Keats, M. C. Hoffman, L. B. Kay, E. S. Miller, T. A. Moore Simas, A. Frieder, B. Hackley, P. Indman, C. Raines, K. Semenuk, K. L. Wisner, and L. A. Lemieux. 2017. Consensus bundle on maternal mental health: Perinatal depression and anxiety. Obstetrics and Gynecology 129(3):422-430.
Krubiner, C. B., R. R. Faden, R. J. Cadigan, S. Z. Gilbert, L. M. Henry, M. O. Little, A. C. Mastroianni, E. E. Namey, K. A. Sullivan, and A. D. Lyerly. 2016. Advancing HIV research with pregnant women: Navigating challenges and opportunities. AIDS 30(15):2261-2265.
Krubiner, C. B., R. R. Faden, R. A. Karron, M. O. Little, A. D. Lyerly, J. S. Abramson, R. H. Beigi, A. R. Cravioto, A. P. Durbin, B. G. Gellin, S. B. Gupta, D. C. Kaslow, S. Kochhar, F. Luna, C. Saenz, J. S. Sheffield, P. O. Tindana, and PREVENT Working Group. 2021. Pregnant women and vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response. Vaccine 39(1):85-120.
Levine, R. J. 1995. Children as research subjects: Ethical and legal considerations. Child and Adolescent Psychiatric Clinics 4(4):853-868.
Mandavilli, A. 2020. What pregnant women should know about coronavirus. New York Times, April 2.
March of Dimes. 2020. Nowhere to go: Maternity care deserts across the U.S. (2020 report). https://www.marchofdimes.org/materials/2020-Maternity-Care-Report.pdf (accessed September 22, 2022).
Mastroianni, A. C., L. M. Henry, D. Robinson, T. Bailey, R. R. Faden, M. O. Little, and A. D. Lyerly. 2017. Research with pregnant women: New insights on legal decision-making. Hastings Center Report 47(3):38-45.
Mastroianni, A. C., R. Franceschini, S. L. Wicks, and L. M. Henry. 2020. The pathway forward: Insights on factors that facilitate research with pregnant women. Ethics Human Research 42(4):2-16. Erratum in: Ethics Human Research 2020. 42(5):16.
NASEM (National Academies of Sciences, Engineering, and Medicine). 2022. Improving representation in clinical trials and research: Building research equity for women and underrepresented groups. Washington, DC: The National Academies Press.
NICHD (National Institute of Child Health and Human Development). n.d. BPCA Best Pharmaceuticals for Children Act history. https://www.nichd.nih.gov/research/supported/bpca/history# (accessed October 10, 2022).
Prasad, S., E. Kalafat, H. Blakeway, R. Townsend, P. O’Brien, T. Morris E, Draycott, S. Thangaratinam, K. Le Doare, S. Ladhani, P. von Dadelszen, L. A. Magee, P. Heath, and A. Khalil. 2022. Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy. Nature Communications 13(1):2414.
Pew Research Center. 2021. Mobile fact sheet. https://www.pewresearch.org/internet/fact-sheet/mobile (accessed September 23, 2022).
Sparks, G., L. Lopes, A. Montero, L. Hamel, and M. Brodie. 2022. KFF Covid-19 vaccine monitor: Pregnancy misinformation—May 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-pregnancy-misinformation-may-2022 (accessed September 22, 2022).
Thurin, N. H., R. Pajouheshnia, G. Roberto, C. Dodd, G. Hyeraci, C. Bartolini, O. Paoletti, H. Nordeng, H. Wallach-Kildemoes, V. Ehrenstein, E. Dudukina, T. MacDonald, G. De Paoli, M. Loane, C. Damase-Michel, A. B. Beau, C. Droz-Perroteau, R. Lassalle, J. Bergman, K. Swart, T. Schink, C. Cavero-Carbonell, L. Barrachina-Bonet, A. GomezLumbreras, M. Giner-Soriano, M. Aragón, A. J. Neville, A. Puccini, A. Pierini, V. Ientile, A. Trifirò, A. Rissmann, M. K. Leinonen, V. Martikainen, S. Jordan, D. Thayer, I. Scanlon, M. E. Georgiou, M. Cunnington, M. Swertz, M. Sturkenboom, and R. Gini. 2022. From inception to ConcePTION: Genesis of a network to support better monitoring and communication of medication safety during pregnancy and breastfeeding. Clinical Pharmacology and Therapeutics 111(1):321-331.
van der Zande, I. S. E., R. van der Graaf, L. Hooft, and J. J. M. van Delden. 2018. Facilitators and barriers to pregnant women’s participation in research: A systematic review. Women and Birth 31(5):350-361.
Whitehead, C. L., and S. P. Walker. 2020. Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. Lancet 395(10237):e92.
Wisner, K. L., D. K. Sit, M. C. McShea, D. M. Rizzo, R. A. Zoretich, C. L. Hughes, H. F. Eng, J. F. Luther, S. R. Wisniewski, M. L. Costantino, A. L. Confer, E. L. Moses-Kolko, C. S. Famy, and B. H. Hanusa. 2013. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry 70(5):490-498.
This page intentionally left blank.
