Ethical challenges in conducting maternal-fetal surgery trials. A systematic review

Abstract

Objective: To present the ethical challenges embedded in published maternal-fetal surgery (MFS) trials and their potential solutions.

Method: Systematic review of normative and empirical literature. We selected articles based on predefined inclusion criteria. QUAGOL methodology was used for analysis.

Results: Forty-three articles were included. We identified two main themes. First, clinical ethics issues. One of the main challenges is balancing rights of the fetus with the rights of the pregnant person. There seems to be an agreement that the pregnant person has the right to decide whether to participate regardless of fetal benefit. Second, research ethics issues. The main issues are difficulties in obtaining a sizeable sample, which lead to trials delays and cancellations, and in obtaining appropriate standardization. These difficulties have important ethical ramifications. For example, trial cancellations due the lack of proper sample size generate a waste of resources and pointlessly place participants at risk as conclusive evidence on MFS efficacy was not obtained.

Conclusions: We need to develop creative solutions that can prevent some of these ethical concerns. We need to involve all the relevant stakeholders in the development process. Further, researchers should discuss what practical issues they encountered and how they addressed them in their publications.

Impact statement: Understanding the ethical challenges embedded in MFS trials will help improving future trials and, consequently, clinical outcomes. To our knowledge, this is the first systematic review unveiling the ethical challenges in maternal-fetal surgery trials. To offer a complete overview of the challenges, we included both normative and empirical literature. We found that the main ethical challenges are practical difficulties that have important ethical ramification. E.g., difficulties in recruitment might hinder scientific validity, which in turn might lead to suboptimal treatment.