Pregnant, or potentially pregnant women have historically been excluded
from clinical trials of new medications. However, it is increasingly
recognised that it is imperative to generate evidence from the
population in whom the drugs are likely to be used in order to inform
safe, evidence-based shared clinical decision making. Reluctance by
researchers and regulators to perform such studies often relates to
concerns about risk, particularly to the fetus. However, this must be
offset against the risk of untreated disease or using a drug in
pregnancy where safety, efficacy and dosing information are not known.
This review summarises the historical perspective, the ethical and legal
frameworks which inform the conduct of such research, then highlights
examples of innovative practice which have enabled high quality, ethical
research to proceed to inform the evidence-based use of medication in
pregnancy.