Clinical Drug Trial Participation: Perspectives of Pregnant Women and Their Spouses

References

• Meyer A, Fermaut M, Drouin J, Carbonnel F, Weill A. Drug use for gastrointestinal symptoms during pregnancy: a French nationwide study 2010–2018. PLoS One. 2021;16(1):e0245854. doi:10.1371/journal.pone.0245854
   Web of Science ®Google Scholar
• Truong MBT, Ngo E, Ariansen H, Tsuyuki RT, Nordeng H. Community pharmacist counseling in early pregnancy-Results from the SafeStart feasibility study. PLoS One. 2019;14(7):e0219424. doi:10.1371/journal.pone.0219424
   Web of Science ®Google Scholar
• van der Straten A, Ryan JH, Reddy K, et al. Influences on willingness to use vaginal or oral HIV PrEP during pregnancy and breastfeeding in Africa: the multisite MAMMA study. J Int AIDS Soc. 2020;23(6):e25536.
   PubMed Web of Science ®Google Scholar
• Saito M, Gilder ME, Nosten F, McGready R, Guérin PJ. Systematic literature review and meta-analysis of the efficacy of artemisinin-based and quinine-based treatments for uncomplicated falciparum malaria in pregnancy: methodological challenges. Malar J. 2017;16(1):488. doi:10.1186/s12936-017-2135-y
   Web of Science ®Google Scholar
• Kreuder AE, Bolaños-Rosales A, Palmer C, et al. Inspired by the human placenta: a novel 3D bioprinted membrane system to create barrier models. Sci Rep. 2020;10(1):15606. doi:10.1038/s41598-020-72559-6
   Web of Science ®Google Scholar
• Lyerly AD, Little MO, Faden R. The second wave: toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008;1(2):5–22. doi:10.3138/ijfab.1.2.5
   PubMedGoogle Scholar
• Payne P. Including pregnant women in clinical research: practical guidance for institutional review boards. Ethics Hum Res. 2019;41(6):35–40. doi:10.1002/eahr.500036
   Google Scholar
• White A. Accelerating the paradigm shift toward inclusion of pregnant women in drug research: ethical and regulatory considerations. Semin Perinatol. 2015;39(7):537–540. doi:10.1053/j.semperi.2015.08.008
   Web of Science ®Google Scholar
• Allesee L, Gallagher CM. Pregnancy and protection: the ethics of limiting a pregnant woman’s participation in clinical trials. J Clin Res Bioeth. 2011;2(108). doi:10.4172/2155-9627.1000108
   Google Scholar
• Gruber MF. The US FDA pregnancy lactation and labeling rule - Implications for maternal immunization. Vaccine. 2015;33(47):6499–6500. doi:10.1016/j.vaccine.2015.05.107
   PubMed Web of Science ®Google Scholar
• National Health Commission of China. Review method of biomedical research ethics involving human beings; 2016.
   Google Scholar
• Meshaka R, Jeffares S, Sadrudin F, Huisman N, Saravanan P. Why do pregnant women participate in research? A patient participation investigation using Q-Methodology. Health Expect. 2017;20(2):188–197. doi:10.1111/hex.12446
   Web of Science ®Google Scholar
• Wada K, Evans MK, de Vrijer B, Nisker J. Clinical research with pregnant women: perspectives of pregnant women, health care providers, and researchers. Qual Health Res. 2018;28(13):2033–2047. doi:10.1177/1049732318773724
   Web of Science ®Google Scholar
• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–2194. doi:10.1001/jama.2013.281053
   PubMed Web of Science ®Google Scholar
• Schwab D. Construct validity in organizational behavior. Res Organ Behav. 1980;2(1):3–43.
   Google Scholar
• Rummel RJ. Applied Factor Analysis. Northwestern University Press; 1970.
   Google Scholar
• MacCallum RC, Widaman KF, Preacher KJ, Hong S. Sample size in factor analysis: the role of model error. Multivariate Behav Res. 2001;36(4):611–637. doi:10.1207/S15327906MBR3604_06
   PubMed Web of Science ®Google Scholar
• Mealy RN, Richardson LA, Miller B, Smith M, Juvancic-Heltzel JA. Exercise is medicine(®): knowledge and awareness among exercise science and medical school students. Int J Exerc Sci. 2019;12(3):505–514.
   Google Scholar
• Isoherranen N, Thummel KE. Drug metabolism and transport during pregnancy: how does drug disposition change during pregnancy and what are the mechanisms that cause such changes? Drug Metab Dispos. 2013;41(2):256–262. doi:10.1124/dmd.112.050245
   PubMed Web of Science ®Google Scholar
• Lupattelli A, Spigset O, Twigg MJ, et al. Medication use in pregnancy: a cross-sectional, multinational web-based study. BMJ Open. 2014;4(2):e004365. doi:10.1136/bmjopen-2013-004365
   PubMed Web of Science ®Google Scholar
• Taylor MM, Kara EO, Araujo MAL, et al. Phase II trial evaluating the clinical efficacy of cefixime for treatment of active syphilis in non-pregnant women in Brazil (CeBra). BMC Infect Dis. 2020;20(1):405. doi:10.1186/s12879-020-04980-1
   Web of Science ®Google Scholar
• Derauf C, Kekatpure M, Neyzi N, Lester B, Kosofsky B. Neuroimaging of children following prenatal drug exposure. Semin Cell Dev Biol. 2009;20(4):441–454. doi:10.1016/j.semcdb.2009.03.001
   PubMed Web of Science ®Google Scholar
• Matsui D. Adherence with drug therapy in pregnancy. Obstet Gynecol Int. 2012;2012:796590. doi:10.1155/2012/796590
   PubMedGoogle Scholar
• Haas DM, Marsh DJ, Dang DT, et al. Prescription and other medication use in pregnancy. Obstet Gynecol. 2018;131(5):789–798. doi:10.1097/AOG.0000000000002579
   PubMed Web of Science ®Google Scholar
• Salas SP. Ethical challenges posed by clinical trials in preterm labor: a case study. Reprod Health. 2017;14(Suppl 3):168. doi:10.1186/s12978-017-0427-x
   Web of Science ®Google Scholar
• Lyerly AD, Namey EE, Gray B, Swamy G, Faden RR. Women’s views about participating in research while pregnant. Ethics Hum Res. 2012;34(4):1–8.
   Google Scholar
• Monteiro TM, Katz L, Bento SF, Amorim MM, Moriel PC, Pacagnella RC. Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis. BMC Pregnancy Childbirth. 2019;19(1):97. doi:10.1186/s12884-019-2240-8
   Web of Science ®Google Scholar
• Wilcox CR, Calvert A, Metz J, et al. Attitudes of pregnant women and healthcare professionals toward clinical trials and routine implementation of antenatal vaccination against respiratory syncytial virus: a multicenter questionnaire study. Pediatr Infect Dis J. 2019;38(9):944–951. doi:10.1097/INF.0000000000002384
   PubMed Web of Science ®Google Scholar
• McQuaid F, Pask S, Locock L, et al. Attitudes towards antenatal vaccination, Group B streptococcus and participation in clinical trials: insights from focus groups and interviews of parents and healthcare professionals. Vaccine. 2016;34(34):4056–4061. doi:10.1016/j.vaccine.2016.06.024
   Web of Science ®Google Scholar
• Strömmer S, Lawrence W, Rose T, et al. Improving recruitment to clinical trials during pregnancy: a mixed methods investigation. Soc Sci Med. 2018;200:73–82. doi:10.1016/j.socscimed.2018.01.014
   PubMed Web of Science ®Google Scholar
• Myles S, Tocci C, Falk M, et al. A multicenter investigation of factors influencing women’s participation in clinical trials. J Womens Health. 2018;27(3):258–270. doi:10.1089/jwh.2017.6458
   Web of Science ®Google Scholar
• Scaffidi J, Mol BW, Keelan JA. The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy. BJOG. 2017;124(1):132–140. doi:10.1111/1471-0528.14151
   Web of Science ®Google Scholar
• Sheffield JS, Siegel D, Mirochnick M, et al. Designing drug trials: considerations for pregnant women. Clin Infect Dis. 2014;59(Suppl 7):S437–S444. doi:10.1093/cid/ciu709
   PubMed Web of Science ®Google Scholar