Division of Maternal Fetal Medicine, Department Obstetrics & Gynecology, The Ohio State University Wexner Medical Center, 395 W12th Avenue, Columbus, OH, 43210, USA.
J Pharmacokinet Pharmacodyn. 2020 Aug;47(4):287-293. doi: 10.1007/s10928-020-09687-z. Epub 2020 Apr 18.
Maternal mortality and morbidity continue to rise in the United States. Despite these trends there are limited novel interventions to investigate and improve these metrics, partly due to research protocol limitations which restrict participation of pregnant women. Inclusion of pregnant women in research studies is integral to the process of obtaining important information regarding the safety and efficacy of therapeutics or interventions to improve maternal health and pregnancy outcomes. While significant changes in research practices have resulted in an increase of female participants, there remains a paucity of research trials directly targeting pregnant and lactating women. This article provides an overview of issues surrounding inclusion of pregnant or breastfeeding women in research studies, and includes historical perspectives, navigating concerns over safety profile, considerations for appropriate development, and future perspectives.
美国的孕产妇死亡率和发病率仍在上升。尽管存在这些趋势，但由于研究方案的限制限制了孕妇的参与，因此可用于调查和改善这些指标的新干预措施有限。将孕妇纳入研究对于获取有关治疗药物或干预措施安全性和有效性的重要信息至关重要，这些措施可以改善母婴健康和妊娠结局。虽然研究实践的重大变化导致女性参与者的增加，但直接针对孕妇和哺乳期妇女的研究试验仍然很少。本文概述了将孕妇或哺乳期妇女纳入研究的相关问题，包括历史观点、解决安全性问题、考虑适当的开发以及未来展望。
