Obstetrics and Gynecology

June 21, 2022

From its beginnings, maternal-fetal surgery (MFS) has held promise for ameliorating disabilities caused by conditions in utero. Yet MFS has presented ethical challenges that must be reevaluated as technology progresses and more MFS procedures become possible.

In this vein, Mayo Clinic investigators undertook a review of 37 peer-reviewed, English-language maternal-fetal surgery papers including ethical discussions published between January 1999 and October 2020. The researchers published findings in a 2022 issue of Journal of Perinatal Medicine.

"Because fetal therapy is advancing rapidly with new technology and diagnostic methods for in utero abnormalities, it's imperative to keep up with advances by evaluating the proposed interventions and securing that they are ethically sound," says Mauro H. Schenone, M.D., a maternal-fetal medicine specialist at Mayo Clinic in Minnesota.

Evolution of MFS

Fetal therapy and surgery is a relatively young discipline. Its beginnings date back to the 1960s when it was used as an intervention for fetuses affected by anemia due to Rh alloimmunization. Subsequently, physicians developed procedures and therapies to treat other fatal conditions such as lower urinary tract obstruction, congenital diaphragmatic hernias and sacral teratomas. After adding treatment in the 1980s for disabling or life-threatening conditions such as hydrocephalus with ventroculo-amniotic fluid shunting and twin-twin transfusion syndrome, the 1990s saw interventions to close myelomeningocele prenatally and the advent of MFS clinical trials.

Enthusiasm grew for providing therapy in utero; the field expanded through efforts to decrease high morbidity for certain conditions and address disabilities that can be less severe when treated prenatally versus postnatally. In these efforts, maternal-fetal surgeons faced ethical issues raised by surgery at this juncture in pregnancy and fetal development.

Surgeons perform many types of MFS today; the most common procedures include:

• Myelomeningocele repair
• Laser ablation in twin-twin transfusion syndrome
• Acardiac twin radiofrequency ablation
• Fluid-draining shunt insertion
• Intrauterine transfusion
• Tracheal occlusion for treatment of severe congenital diaphragmatic hernias

Ethical themes addressed in this study

In the study's reviewed publications, ethical considerations centered around maternal versus fetal interests. Key ethical themes that emerged in the literature included:

• Fetus as a patient. The investigators noted debate regarding fetal patient status in many publications, crucial for whether one or two patients have corresponding rights.

  Factors mentioned in the study regarding fetal status as a patient include:

  • Fetus meets viability standards
  • Mother's intention to continue pregnancy if the fetus is nonviable
  • Mother's desire for fetal care
  • Dependent morality, often influenced by religion and societal views

• Balancing maternal-fetal risks and benefits. The Mayo authors argue that determining the level of benefit needed to justify the risks of MFS is central to the field's ethics. They state that the most popular viewpoint is that maternal risk, possible fetal benefits and maternal independent decision-making ability must be equally weighted, per a 2008 publication by Dr. Noble and colleagues and a 2018 paper by Dr. Silberberg and team.

  MFS incurs maternal and fetal risk; thus, the clinician's job is to provide thoughtful and informed input to the mother, who weighs the issues and decides whether to proceed.

  "Anytime you interfere in the uterus, it introduces risk," says Megan A. Allyse, Ph.D., a reproductive health researcher and medical ethicist at Mayo Clinic in Florida and fellow author of the Mayo study. "It's designed as a perfect bubble. Anytime you insert instruments in there and move them around, it introduces some degree of risk. If it is possible to wait till post-delivery to intervene, we do. We pursue cases where intervention later would not be as beneficial."

  Maternal and fetal MFS risks may include:

  • Fetal death
  • Preterm labor, increasing long-term mental and physical disability risks
  • Maternal or fetal surgical complications, or future pregnancy issues
  • Unsuccessful birth defect repair
  • Impact on other fetuses in multiple gestations
  • Additional surgery stemming from MFS

  "Our job is presenting risks and benefits and helping the pregnant patient understand and decide," states Dr. Allyse.

  She notes that medical professionals must inform intended parents about the following before fetal procedures:

  • This is not curative such that the baby will be healthy for life.
  • This is therapeutic, but most of these babies will have a neonatal intensive care unit stay.

  However, per the authors, MFS can also lead to live birth or decreased short- and long-term morbidity, such as in spina bifida MFS, where surgery increases ambulation potential in later development. MFS has radically altered quality of life for fetuses with myelomeningocele, considered one of the most complex congenital birth defects compatible with life per a 2016 study published in Child: Care, Health and Development. The Mayo investigators propose that benefits to a child's health through MFS also may extend to the family.

  The authors point out absence of direct maternal medical benefit in fetal intervention, instead offering psychosocial and sociological impact, noted by Dr. Bartlett and colleague in 2020.

• Informed consent. A primary MFS concern is providing extensive informed consent, say the Mayo authors. Crucial to this process for fetal procedures is respect for maternal autonomy. Ultimately, MFS proceeds only if the mother wants to go forward — no one may compel the patient to undertake fetal intervention — and the patient and the physician have discussed risks and benefits, per Dr. Schenone. Also, the mother has the right to involve anyone in decision-making, though only the mother makes MFS decisions.

  Dr. Allyse elaborates on maternal autonomy: "In medical practice today, patients may decide what's best for them," she says. "However, till the 1960s, many physicians didn't ask patients. They just proceeded, especially with women. But in the 1970s, women began stating, 'You can't tell me what is best for my body: I get to decide.' "

  The authors state that clinicians must support maternal decision-making and offer medically reasonable alternatives, including postnatal intervention. This input should be multidisciplinary, presenting the mother with long-term potential outcomes, according to Dr. Noble and colleagues, as well as Dr. Van Calenbergh and colleagues.

  Due to maternal autonomy, Dr. Allyse encourages clinicians to avoid making assumptions about maternal needs and to let patients have a voice. Dr. Allyse deems overruling mothers' decisions regarding best course of action for themselves and their fetuses unethical.

• Distinction between research and therapy. Another MFS therapeutic option may involve nonstandard or rare procedures or procedural variants that are typically assessed via formal research protocols. With these protocols, clinicians must clearly delineate between standard therapy and fetal research. This also includes separating protocol success from successful therapy.

  Dr. Schenone notes that unlike procedures for standard fetal interventions, the requirements to proceed with innovative procedures may include multidisciplinary meetings, research protocols and special authorizations from the Food and Drug Administration. Also, some protocols may require consent from all intended parents. If parents disagree, clinicians must lead conversations to help bring consensus, per Dr. Allyse, explaining that this is crucial when fetal conditions dictate limited available time.

  Other ethical considerations raised concerning research protocols include that they may present uncertainties about an intervention's potential benefits, and whether investigators should exclude women considering termination from research protocols.

• Provision of maternal-fetal surgery. The authors indicate they hope to see equitable MFS distribution where it has previously been lacking, while acknowledging that MFS requires resources, costly equipment and technology, and specialized providers.

  Simultaneously, they argue for MFS standards, such as:

  • Implementation at specialized centers by experienced fetal surgeons demonstrating success
  • Conduct at centers with trainees to spread knowledge geographically
  • Ability to address MFS complications at the center conducting the procedure
  • Straightforwardness with patients about outcomes, procedure volumes and services rendered

The Mayo Clinic authors call for continued clinical trials to better comprehend MFS risks and outcomes and address relevant ethical issues. They urge balancing of maternal and fetal interests, greater MFS access equity and vigorous informed consent practices.

Mayo Clinic's maternal-fetal surgery practice and thoughts for referring physicians

Dr. Schenone is available to discuss any cases in which physicians are considering potential fetal intervention and referral, including via eConsult.

While indicating that most Mayo Clinic fetal procedures are well known and standard, unique cases also arise. These may have no institutional precedent or represent a substantial variant or expansion of an existing fetal procedure. In such cases, the maternal-fetal surgeon provides information to the fetal ethics advisory board on the proposed procedure. This board discusses issues with the surgeon and provides recommendations on the potential surgery and information to convey so that the pregnant patient can choose.

"The ultimate goal is to achieve zero decisional regret," says Dr. Allyse. "We want the patient to look back and say, 'I made the right decision based on what I knew at the time.' "

For more information

Rousseau AC, et al. Ethical considerations of maternal-fetal surgery. Journal of Perinatal Medicine. In press.

Noble R, et al. Ethical considerations of fetal therapy. Best Practice & Research Clinical Obstetrics & Gynaecology. 2008;22:219.

Silberberg A, et al. Ethical issues in intrauterine myelomeningocele surgery. The New Bioethics: A Multidisciplinary Journal of Biotechnology and the Body. 2018;24:249

Bakaniene I, et al. Health-related quality of life in children with myelomeningocele: A systematic review of the literature. Child: Care, Health and Development. 2016;42:625.

Bartlett VL, et al. Retrieving the moral in the ethics of maternal-fetal surgery. Cambridge Quarterly of Healthcare Ethics. 2020;29:480.

Van Calenbergh F, et al. Maternal-fetal surgery for myelomeningocele: Some thoughts on ethical, legal, and psychological issues in a Western European situation. Child's Nervous System. 2017;33:1247.

Rousseau, A., et al. Journal of Perinatal Medicine. 2022.

Chervenak FA, et al. Ethics of fetal surgery. Clinics in Perinatology. 2009;36:237.

Refer a patient to Mayo Clinic.