Ethical Considerations Concerning Amnioinfusions for Treating Fetal Bilateral Renal Agenesis

Abstract

Congenital bilateral renal agenesis has been considered a uniformly fatal condition. However, the report of using serial amnioinfusions followed by the live birth in 2012 and ongoing survival of a child with bilateral renal agenesis has generated hope, but also considerable controversy over an array of complex clinical and ethical concerns. To assess the ethical concerns associated with using serial amnioinfusions for bilateral renal agenesis, we assembled a multidisciplinary group to map the ethical issues relevant to this novel intervention. The key ethical issues identified were related to 1) potential risks and benefits, 2) clinical care compared with innovation compared with research, 3) counseling of expectant parents, 4) consent, 5) outcome measures, 6) access and justice, 7) conflicts of interest, 8) effects on clinicians, 9) effects on institutions, and 10) long-term societal implications. These ethical issues should be addressed in conjunction with systematic efforts to examine whether this intervention is safe and effective. Future work should capture the experiences of expectant parents, women who undergo serial amnioinfusions, those born with bilateral renal agenesis and their families as well as clinicians confronted with making difficult choices related to it.

Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial

“…Sugarman et al [46] have summarized the ethical issues around amnioinfusions to treat pulmonary hypoplasia in CoBRA and are summarized here to encompass all diagnoses resulting in EPRA. This analysis should be a part of the decision-making process before beginning a research trial.…”

“…In light of these ethical issues, further discussed elsewhere [46], the multidisciplinary team should take care to counsel interested families before beginning amnioinfusions in the context of a trial. If fetal comorbidities are few or are a direct result of EPRA, serial amnioinfusions may be a beneficial treatment, but success in each step of treatment, from fetal therapy to transplant surgery to long-term adherence to immunosuppressive regimens, is necessary to optimize long-term outcomes.…”

“…Patients should be counseled appropriately about the possibility of termination. Language that indicates bias for or against treatment should be avoided to allow the family to make an independent decision [46]. The family should be informed on the likelihood of survival for the neonate and potential complications for the pregnancy.…”

“…Serial amnioinfusions involve the infusion of normal saline into the amniotic cavity to restore the aqueous environment of the fetus (normal volumes: 25 mL at 10 weeks, 400 mL at 20 weeks, 800 mL at 28 weeks GA) [8]. The timing and frequency of amnioinfusions, along with the optimal timing of delivery, remain uncertain [46]. If pulmonary development is sufficient after birth, neonates will require RRT, including chronic dialysis and kidney transplant.…”

“…Medicare and qualifying Medicaid recipients should be reimbursed for RRT and associated treatments, but there may be uncovered expenses that place a financial burden on the family [58]. Fetal therapy candidates should not be refused based on financial circumstances and an effort should be made to assist these families financially [46]. Cost-effectiveness models may also be beneficial in the future when more data is available for these patients to help determine in which cases fetal treatment should be administered [12].…”