2023 / 02

Next Paper
DOI: 10.24075/medet.2023.011

REVIEW

Pregnant women and their fetuses — orphan populations in respect to the safety and efficacy of medicines

Ushkalova EA1, Zyryanov SK1,2, Butranova OI1
About authors

1 Peoples’ Friendship University of Russia named after Patrice Lumumba (RUDN University), Moscow, Russia

2 Municipal Clinical Hospital No. 24 of Healthcare Department of Moscow, Moscow, Russia

Correspondence should be addressed: Olga I. Butranova
ul. Miklukho-Maklaya, 6, Moscow, 117198, Russia; ur.ndur@io-avonartub

About paper

Author contribution: Ushkalova E. A. — literature analysis, collection, analysis and writing the publication text; Zyryanov S. K.— trial planning, literature analysis; Butranova O. I.— data analysis and interpretation.

Received: 2023-01-30 Accepted: 2023-03-28 Published online: 2023-05-23
|
  1. Hirshberg A, Srinivas SK. Epidemiology of maternal morbidity and mortality. Semin Perinatol. 2017 Oct; 41 (6): 332–337. DOI: 10.1053/j.semperi.2017.07.007.
  2. Frick AP. Advanced maternal age and adverse pregnancy outcomes. Best Pract Res Clin Obstet Gynaecol. 2021 Jan; 70: 92–100. DOI: 10.1016/j.bpobgyn.2020.07.005.
  3. Marchi J, Berg M, Dencker A, Olander EK, Begley C. Risks associated with obesity in pregnancy, for the mother and baby: a systematic review of reviews. Obes Rev. 2015 Aug; 16(8): 621– 38. DOI: 10.1111/obr.12288.
  4. Barrett PM. Editorial: Adverse Pregnancy Outcomes-A Missed Opportunity to Prevent Chronic Disease? Int J Public Health. 2021 Jan 25;66:582810. DOI: 10.3389/ijph.2021.582810.
  5. Graham W, Woodd S, Byass P, Filippi V, Gon G, Virgo S, Chou D, Hounton S, Lozano R, Pattinson R, Singh S. Diversity and divergence: the dynamic burden of poor maternal health. Lancet. 2016 Oct 29; 388 (10056): 2164–2175. DOI: 10.1016/S0140-6736(16)31533-1.
  6. Hauspurg A, Ying W, Hubel CA, Michos ED, Ouyang P. Adverse pregnancy outcomes and future maternal cardiovascular disease. Clin Cardiol. 2018 Feb; 41 (2): 239–246. DOI: 10.1002/ clc.22887.
  7. Meltzer-Brody S, Howard LM, Bergink V, Vigod S, Jones I, Munk-Olsen T, Honikman S, Milgrom J. Postpartum psychiatric disorders. Nat Rev Dis Primers. 2018 Apr 26; 4: 18022. DOI: 10.1038/nrdp.2018.22.
  8. Betcher HK, Wisner KL. Psychotropic Treatment During Pregnancy: Research Synthesis and Clinical Care Principles. J Womens Health (Larchmt). 2020 Mar; 29 (3): 310–318. DOI: 10.1089/jwh.2019.7781.
  9. Spinelli M. Postpartum psychosis: a diagnosis for the DSMV. Arch Womens Ment Health. 2021 Oct; 24 (5): 817–822. DOI: 10.1007/s00737-021-01175-8.
  10. Brockington I. Suicide and filicide in postpartum psychosis. Arch Womens Ment Health. 2017 Feb; 20 (1): 63–69. DOI: 10.1007/ s00737-016-0675-8.
  11. McKiever M, Frey H, Costantine MM. Challenges in conducting clinical research studies in pregnant women. J Pharmacokinet Pharmacodyn. 2020 Aug; 47 (4): 287–293. DOI: 10.1007/s10928-020-09687-z.
  12. Adam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet. 2011 Aug 15; 157C (3): 175–82. DOI: 10.1002/ajmg.c.30313.
  13. Mazer-Amirshahi M, Samiee-Zafarghandy S, Gray G, van den Anker JN. Trends in pregnancy labeling and data quality for US-approved pharmaceuticals. Am J Obstet Gynecol. 2014 Dec; 211 (6): 690.e1–11. DOI: 10.1016/j.ajog.2014.06.013.
  14. Sillis L, Foulon V, Verbakel JY, Ceulemans M. Experiences and Perspectives of Marketing Authorisation Holders towards Medication Safety Monitoring during Pregnancy: A Pan-European Qualitative Analysis. Int J Environ Res Public Health. 2022 Apr 2; 19(7): 4248. DOI: 10.3390/ijerph19074248.
  15. Anderson GD. Pregnancy-induced changes in pharmacokinetics: a mechanistic-based approach. Clin Pharmacokinet. 2005; 44 (10): 989–1008.
  16. Dorfman EH, Cheng EY, Hebert MF, Thummel KE, Burke W. Prenatal pharmacogenomics: a promising area for research. Pharmacogenomics J. 2016 Aug;16 (4): 303–4. DOI: 10.1038/ tpj.2016.33.
  17. Caritis SN, Venkataramanan R. Obstetrical, fetal, and lactation pharmacology-a crisis that can no longer be ignored. Am J Obstet Gynecol. 2021 Jul;225(1):10–20. DOI: 10.1016/j.ajog.2021.02.002.
  18. Shields KE, Lyerly AD. Exclusion of pregnant women from industry-sponsored clinical trials. Obstet Gynecol 2013;122:1077– 81. DOI: 10.1097/AOG.0b013e3182a9ca67.
  19. Sheffield JS, Siegel D, Mirochnick M, Heine RP, Nguyen C, Bergman KL, Savic RM, Long J, Dooley KE, Nesin M. Designing drug trials: considerations for pregnant women. Clin Infect Dis. 2014 Dec 15; 59 Suppl 7(Suppl 7): S437–44. DOI: 10.1093/cid/ciu709.
  20. van der Graaf R, van der Zande ISE, den Ruijter HM, Oudijk MA, van Delden JJM, Oude Rengerink K, Groenwold RHH. Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach. Trials. 2018 Jan 29; 19 (1): 78. DOI: 10.1186/s13063-017-2402-9.
  21. Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017 Feb 7; 15(1): 8. DOI: 10.1186/s12961-016-0164-6.
  22. Boldt J. The concept of vulnerability in medical ethics and philosophy. Philos Ethics Humanit Med. 2019 Apr 11; 14 (1): 6. DOI: 10.1186/s13010-019-0075-6.
  23. Ke AB, Rostami-Hodjegan A, Zhao P, Unadkat JD. Pharmacometrics in pregnancy: An unmet need. Annu Rev Pharmacol Toxicol. 2014; 54: 53–69. DOI: 10.1146/ annurev-pharmtox-011613-140009.
  24. van der Zande ISE, van der Graaf R, Oudijk MA, van Delden JJM. Vulnerability of pregnant women in clinical research. J Med Ethics. 2017 Oct; 43 (10): 657–663. DOI: 10.1136/ medethics-2016-103955.
  25. Payne P. Including Pregnant Women in Clinical Research: Practical Guidance for Institutional Review Boards. Ethics Hum Res. 2019 Nov; 41 (6): 35–40. DOI: 10.1002/eahr.500036.
  26. Samaei M, McGregor AJ, Jenkins MR. Inclusion of women in FDA-regulated premarket clinical trials: A call for innovative and recommended action. Contemp Clin Trials. 2022 May; 116: 106708. DOI: 10.1016/j.cct.2022.106708.
  27. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials/Guidance for Industry. DRAFT GUIDANCE. April 2018. https://www.fda.gov/media/112195/download