Ethical Concerns for Amnioinfusions to Treat Early-Onset Anhydramnios

Abstract

This Viewpoint discusses the long-term medical, emotional, and financial implications of using amnioinfusion to treat anhydramnios; outlines the ongoing Renal Anhydramnios Fetal Therapy (RAFT) trial, which aims to document outcomes and survival in infants after amnioinfusion; and suggests that amnioinfusions be withheld in early anhydramnios, pending the findings of the RAFT trial.

Precarious hope: Ethical considerations for offering experimental fetal therapies outside of research after initial studies in humans

“…10 Pregnant individuals are already asking physicians to provide amnioinfusions for BRA outside clinical trials. 11 Some clinicians are offering it. 11 The publication of the pulmonary survival data from the RAFT trial will likely increase these demands despite uncertainty about long-term benefits and survival.…”

“…11 Some clinicians are offering it. 11 The publication of the pulmonary survival data from the RAFT trial will likely increase these demands despite uncertainty about long-term benefits and survival. When clinicians receive such requests, what should they do?…”

“…22,27 Trials such as RAFT highlight a challenge that has received little attention: whether and how to offer experimental fetal therapies as innovative therapy after some early human data have been obtained, but significant uncertainty about the risk-benefit profile and appropriate management remains. 11 The remaining uncertainty after initial studies may relate to long-term outcomes (like after RAFT) or may also include short-term outcomes (e.g., if the study was underpowered). Both positive and negative initial research findings may influence considerations related to offering experimental fetal therapies.…”

Ethical Concerns for Amnioinfusions

“…To the Editor A recent Viewpoint highlighted the critical need for comprehensive multidisciplinary consultation to support families considering amnioinfusions to promote fetal lung development in pregnancies complicated by early anhydramnios . The Renal Anhydramnios Fetal Therapy (RAFT) trial was designed as the first trial to assess the maternal safety and short-term efficacy of serial amnioinfusions to mitigate pulmonary hypoplasia associated with early anhydramnios.…”

Bilateral Renal Agenesis—Interpreting the RAFT Trial

“…The authors performed a multicenter nonrandomized clinical trial of pregnancies complicated by bilateral renal agenesis and anhydramnios due to fetal anuria to assess whether the infants of participants who agreed to serial amnioinfusions initiated prior to 26 weeks’ gestation to promote lung development would survive to 14 days of life or longer and receive placement of dialysis access. Even before the RAFT trial results were published, there was controversy about serial amnioinfusions for fetal bilateral renal agenesis . A key concern has been whether the goal for survival benefit is worth the risks (eg, complications associated with prematurity, dialysis, life-limiting kidney disease) .…”