PFM.08 Ethics and ethical evaluation of a proposed clinical trial with maternal uterine artery vascular endothelial growth factor gene therapy to treat severe early-onset fetal growth restriction in pregnant women

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Abstract

The EVERREST programme proposes a clinical trial with maternal uterine artery vascular endothelial growth factor gene therapy to treat severe early-onset fetal growth restriction (FGR) in pregnant women. FGR is a major obstetric problem that has significant risk of stillbirth or very low birthweight baby. As a component of this programme a literature review on the ethical and legal issues of highly experimental treatments in pregnant women was conducted to evaluate the ethical and social acceptability of the proposed clinical trial. The review was followed by 34 qualitative interviews amongst key stakeholder groups in several European countries.

The literature considered two main questions; whether it is ethical to treat a pregnant woman with a potentially risky treatment when she herself has no benefit from the treatment, and secondly, whether it is ethical to treat this condition of the unborn who may otherwise have died but with the treatment may be born with a serious disability. The review concluded that there was no ethical or legal objection to the intervention under development nor to a trial of this intervention.

The main issues emerging in the empirical interviews turned on the psychological stress of the woman making a decision about trial participation after just having been informed of the diagnosis of severe FGR, and secondly, the need for accurate and adequate information together with psychological support as part of a continuous informed consent process. Further interviews will be conducted with women and their partners who have experienced a pregnancy affected by FGR.

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