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Chapter 17 - Clinical Innovation and Research in Obstetrics and Gynecology

from Section 5 - Professionally Responsible Innovation and Research

Published online by Cambridge University Press:  01 November 2019

Laurence B. McCullough ,
John H. Coverdale  and
Frank A. Chervenak
Laurence B. McCullough
Affiliation:
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
John H. Coverdale
Affiliation:
Baylor College of Medicine, Texas
Frank A. Chervenak
Affiliation:
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
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Summary

This chapter provides an ethical framework to guide clinical innovation and research in obstetrics and gynecology.

Improving the quality of obstetric and gynecologic care depends on clinical innovation and research. Innovation and research are both experimentation. An experiment occurs when in deliberative clinical judgment the outcomes of a clinical intervention cannot be reliably predicted.

Type
Chapter
Information
Professional Ethics in Obstetrics and Gynecology , pp. 201 - 214
Publisher: Cambridge University Press
Print publication year: 2019

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References

Chervenak, FA, McCullough, LB. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. Am J Bioeth 2011; 11: 39–49.Google Scholar
North American Fetal Therapy Network. Available at NAFTNET.org (accessed January 14, 2019).Google Scholar
Sala, P, Prefumo, F, Pastorino, D, Buffi, D, et al. Fetal surgery: an overview. Obstet Gynecol Surv 2014; 69: 218–228.Google Scholar
American College of Obstetricians and Gynecologists. Committee on Ethics; American Academy of Pediatrics, Committee on Bioethics. Committee Opinion No. 501: Maternal-fetal intervention and fetal care centers. Obstet Gynecol 2011; 118: 405–410.Google Scholar
Moise, K. The history of fetal therapy. Am J Perinatol 2014; 31: 557–566.Google Scholar
Biffl, WL, Spain, DA, Rietsma, AM, et al. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg 2008; 206: 1204–1209.Google Scholar
Chervenak, FA, McCullough, LB. The ethics of maternal-fetal surgery. Semin Fetal Neonatal Med 2018; 23: 64–67.Google Scholar
Adzick, NS, Thom, EA, Spong, CY, et al. MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med 2011; 364: 993–1004.Google Scholar
Brody, BA. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press, 1998.Google Scholar
Heyrana, K, Myers, B, Stratton, P. Increasing the participation of pregnant women in clinical trials. JAMA 2018; 320: 2077–2078.Google Scholar
Brody, BA, McCullough, LB, Sharp, R. Consensus and controversy in research ethics. JAMA 2005; 294: 1411–1414.Google Scholar
Appelbaum, PS, Roth, LH, Lidz, C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982; 5: 319–239.CrossRefGoogle ScholarPubMed
Lidz, CW, Appelbaum, PS, Grisso, T, Renaud, M. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 2004; 58: 1689–1697.Google Scholar
American College of Obstetricians and Gynecologists. ACOG Committee on Practice Bulletins – Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008. Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol 2008; 111: 1001–1020.CrossRefGoogle Scholar
McCullough, LB, Coverdale, J, Chervenak, F. Ethical challenges of decision making with pregnant patients who have schizophrenia. Am J Obstet Gynecol 2002; 187: 696–700.Google Scholar
Coverdale, J, McCullough, LB, Chervenak, FA. The ethics of randomized placebo-controlled trials of antidepressants with pregnant women. A systematic review. Obstet Gynecol 2008; 112: 1361–1368.Google Scholar
Hartz, SM, Pato, CN, Medeiros, H, Cavazos-Rehg, P, et al. Comorbidity of severe psychotic disorders with measures of substance use. JAMA Psychiatry 2014; 71: 248–254.Google Scholar
Coverdale, J, Turbott, SH. Sexual and physical abuse of chronically ill psychiatric outpatients compared to men with a matched sample of medical outpatients. J Nerv Ment Dis 2000; 188: 440–445.Google Scholar
Kamperman, AM, Henrichs, J, Bogaerts, S, Lesaffee, EM, et al. Criminal victimization in people with severe mental illness: a multi-site prevalence and incidence survey in the Netherlands. PLoS ONE 2014, March 7; 9(3): e90129.CrossRefGoogle ScholarPubMed
Khalifeh, H, Oram, S, Osborn, D, Howard, LM, Johnson, S. Recent physical and sexual violence against adults with severe mental illness: a systematic review and meta-analysis. Int Rev Psychiatry 2016; 28(5): 433–451.Google Scholar
Oram, S, Trevillion, K, Feder, G, Howard, LM. Prevalence of experiences of domestic violence among psychiatric patients: a systematic review. Br J Psychiatry 2013; 202: 94–99.Google Scholar
Teplin, LA, McClelland, GM, Abram, KM, Weiner, DA. Crime victimization in adults with severe mental illness: comparison with the National Crime Victimization Survey. Arch Gen Psychiatry 2005; 62: 911–921.Google Scholar
Coughlin, CG, Blackwell, KA, Bartley, C, Hay, M, Yonkers, KA, Bloch, MH. Obstetric and neonatal outcomes after antipsychotic medication exposure in pregnancy. Obstet Gynecol 2015; 125: 1224–1235.Google Scholar
Jablensky, AV, Morgan, V, Zubrick, SR, Bower, C, Yellachich, L-A. Pregnancy, delivery, and neonatal complications in a population cohort of women with schizophrenia and major affective disorders. Am J Psychiatry 2005; 162: 79–91.Google Scholar
Schneid-Kofman, N, Sheiner, E, Levy, A. Psychiatric illness and adverse pregnancy outcome. Int J Gynaecol Obstet 2008; 101: 53–56.CrossRefGoogle ScholarPubMed
Webb, R, Abel, K, Pickles, A, Appleby, L. Mortality in offspring of patients with psychotic disorders: a critical review and meta-analysis. Am J Psychiatry 2005; 162: 1045–1056.Google Scholar
Tosato, S, Albert, U, Tomassi, S, Lasevoli, F, Carmassi, C, Nanni, MG, et al. A systematized review of atypical antipsychotics in pregnant women: balancing between risks of untreated illness and risks of drug-related adverse effects. J Clin Psychiatry 2017; 78: e477–e489.Google Scholar
Webb, RT, Howard, L, Abel, KM. Antipsychotic drugs for non-affective psychosis during pregnancy and postpartum. Cochrane Database Syst Rev 2004; 2: CD004411.Google Scholar
Council for the International Organization of Medical Societies (CIOMS), in conjunction with the World Medical Association (WMA). International Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS, 2002. Available at www.cioms.ch/publications/layout_guide2002.pdf (accessed March 1, 2019).Google Scholar
McCullough, LB, Coverdale, J, Chervenak, FA. A comprehensive ethical framework for responsibly designing and conducting pharmacologic research that involves pregnant women. Am J Obstet Gynecol 2005; 193: 901–907.Google Scholar
McCullough, LB, Chervenak, FA, Coverdale, J. An ethical framework for conducting research on pregnant, opioid-dependent women. Addiction 2013; 108: 248–249.Google Scholar
Miller, LJ. Psychotic denial of pregnancy: phenomenology and clinical management. Hosp Comm Psychiatry 1990; 41: 1233–1237.Google Scholar
Babbitt, KE, Bailey, KJ, Coverdale, J, Chervenak, FA, McCullough, LB. Professionally responsible intrapartum management of patients with major mental disorders. Am J Obstet Gynecol 2014; 210: 27–31.Google Scholar
McCullough, LB, Chervenak, FA, Coverdale, J. Managing care of an intrapartum patient with agitation and psychosis: ethical and legal implications. AMA J Ethics 2016; 18: 209–214.Google Scholar
Coverdale, J, Turbott, SH, Roberts, H. Family planning needs and STD risk behaviors of female psychiatric outpatients. Br J Psychiatry 1997; 171: 69–72.Google Scholar
Boden, R, Lundgren, M, Brandt, L, Reutfors, J, Kieler, H. Antipsychotics during pregnancy; relation to fetal and maternal metabolic effects. Arch Gen Psychiatry 2012; 69: 715–721.Google Scholar
Reis, M, Kallen, B. Maternal use of antipsychotics in early pregnancy and delivery outcome. J Clin Psychopharmacol 2008; 28: 279–288.Google Scholar
McKenna, K, Koren, G, Tetelbaum, M, Wilton, L, Shakir, S, Diav-Citrin, O, et al. Pregnancy outcome of women using atypical antipsychotic drugs: a prospective comparative study. J Clin Psychiatry 2005; 66: 444–449.Google Scholar
Nilsson, E, Lichtenstein, P, Cnattingius, S, Murray, RM, Hultman, CM. Women with schizophrenia: pregnancy outcome and infant death among their offspring. Schizophrenia Research 2002; 58: 221–229.Google Scholar
Newham, JJ, Thomas, SH, MacRitchie, K, McElhatton, PR, McAllister-Williams, RH. Birth weights of infants after maternal exposure to typical and atypical antipsychotics; prospective comparison study. Br J Psychiatry 2008; 192: 333–337.Google Scholar
Eke, AC, Saccone, G, Berghella, V. Selective serotonin reuptake inhibitor (SSRI) use during pregnancy and risk of preterm birth: a systematic review and meta-analysis. BJOG 2016; 123: 1900–1907.Google Scholar
Hemels, ME, Einarson, A, Koren, G, Lanctot, KL, Einarson, TR. Antidepressant use during pregnancy and the rates or spontaneous abortions: a meta-analysis. Am Pharmacother 2005; 39: 803–809.Google Scholar
Masarwa, R, Bar-Oz, B, Gorelik, E, Reif, S, Perlman, A, Matok, I. Prenatal exposure to selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors and risk for pulmonary hypertension of the newborn: a systematic review, meta-analysis, and network meta-analysis. Am J Obstet Gynecol 2019; 220: 57.e1–57.Google Scholar
Andrade, C. Antidepressant exposure during pregnancy and risk of autism in the offspring, 1. Meta-review of meta-analyses. J Clin Psychiatry 2017; 78: e1047–e1051.Google Scholar
Lin, HC, Chen, IJ, Chen, YH, Lee, HC, Wu, FJ. Maternal schizophrenia and pregnancy outcome: does the use of antipsychotics make a difference? Schizophr Res 2010; 116: 55–60.CrossRefGoogle Scholar
Altshuler, LL, Cohen, L, Szuba, MP, Burt, VK, Gitlin, M, Mintz, J. Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. Am J Psychiatry 1996; 153: 592–606.Google Scholar
Diav-Citrin, O, Shechtman, S, Ornoy, S, Amon, J, Schaefer, C, et al. Safety of haloperidol and penfluridol in pregnancy: a multicenter, prospective, controlled study. J Clin Psychiatry 2005; 66: 317–322.Google Scholar
Gentile, S. Antipsychotic therapy during early and late pregnancy. A systematic review. Schizophr Bull 2010; 36: 518–544.Google Scholar
Habermann, F, Fritzsche, J, Fuhlbruck, F, Wacker, E, Allignol, A, et al. Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study. J Clin Psychopharmacol 2013; 33: 453–462.Google Scholar
Huybrechts, KF, Hernandez-Diaz, S, Patorno, E, et al. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry 2016; 73: 938–946.Google Scholar
Frayne, J, Nguyen, T, Bennett, K, Allen, S, Hauck, Y, Liira, H. The effects of gestational use of antidepressants and antipsychotics on neonatal outcomes for women with severe mental illness. Aust NZ J Obstet Gynecol 2017; 57: 526–532.CrossRefGoogle ScholarPubMed
Petersen, I, McCrea, RL, Sammon, CJ, et al. Risks and benefits of psychotropic medications in pregnancy: cohort studies based on UK electronic primary health records. Health Technol Assess 2016; 20: 1–176.Google Scholar
Johnson, KC, LaPrairie, JL, Brennan, PA, Stowe, ZN, Newport, J. Prenatal antipsychotic exposure and neuromotor performance during infancy. Arch Gen Psychiatry 2012; 69: 787–794.Google Scholar
Brown, HK, Dennis, C-L, Kurdyak, P, Vigod, SN. A population-based study of the frequency and predictors of induced abortion among women with schizophrenia. Br J Psychiatry 2018; DOI:10.1192/bjp.2018.262.Google Scholar

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