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PEDIATRICS Vol. 103 No. 5 May 1999, pp. 1061-1063
AMERICAN ACADEMY OF PEDIATRICS:
Fetal Therapy
Ethical Considerations
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ABSTRACT |
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Decisions to undertake fetal therapy involve a complex assessment of the best interests of the fetus and a pregnant woman's interest in her own health and freedom from unwanted invasion of her body. Pregnant women almost always accept a recommendation for fetal therapy that is approached collaboratively, especially if the therapy is of proven efficacy and has a low maternal risk. Fetal therapy of unproven efficacy should only be undertaken as part of an approved research protocol. In recommending fetal therapy of proven efficacy, physicians should respect maternal choice and assessment of risk. Under limited circumstances when fetal therapy would be effective in preventing irrevocable and substantial fetal harm with negligible risk to the health and well-being of the pregnant woman, should the pregnant woman be opposed to the intervention, physicians should engage in a process of communication and conflict resolution that may require consultation from an ethics committee and, in rare cases, require judicial review. A physician should never intervene without the woman's explicit consent before judicial review.
The practice of caring for a pregnant woman and her fetus
has always had the dual goal of a good outcome for both. In pursuit of
this goal, the pregnant woman has always had to consider undergoing her
own risks or discomforts for the sake of her fetus. With recent advances in perinatal medicine, the pregnant woman and her fetus are
increasingly viewed as two treatable patients.1 Fetal medicine is now well-established and offers a range of diagnostic and therapeutic modalities. However, the maternal-fetal relationship is
unique because access to the fetus is through the pregnant woman. As a
result, fetal evaluation and therapy have created a variety of ethical
questions about a physician's responsibility when the interests of a
pregnant woman and her fetus appear to be in conflict.
Decisions by pregnant women concerning fetal diagnostic and therapeutic
interventions clearly involve considerations as to what is best for the
fetus. However, these decisions also involve the woman's interest in
her own health and freedom from unwanted invasion of her body because
all diagnostic and therapeutic interventions on behalf of a fetus
necessarily affect the pregnant woman and require her direct
participation. Thus, fetal therapy poses a potential conflict between
the pregnant woman's own best interests, and her (and others')
perception of the best interests of her fetus.2 The
dilemma of the surrogate decision maker (such as a son or daughter) who
must balance his or her own interests and the interests of the patient
(such as an elderly parent) is not new to medicine; however, in these
other contexts, the surrogate decision maker's health and freedom from
unwanted bodily invasion are rarely directly affected by the
decision.3 In addition, the pregnant woman's physician
may face a potential conflict between his or her primary responsibility
for the woman's health and well-being and a secondary responsibility
for the health of the fetus.
Previously, making decisions about maternal and fetal well-being was
the sole purview of the pregnant woman and her physician. This
relationship developed during a period when virtually all interventions
for fetal well-being were directed specifically toward the general
health of the mother and not specifically for the fetus. Now, however,
many therapeutic interventions can be directed toward specific medical
and surgical problems with the fetus. In light of this complexity, it
is beneficial for involved primary care physicians, pediatricians, and
subspecialists (such as neonatologists, perinatologists, pediatric
surgeons, cardiologists, and geneticists) to advise the obstetrician
and the woman when complex fetal diagnostic and therapeutic
interventions are contemplated. A team of consulting
professionals should be brought together in a collaborative and
multidisciplinary fetal treatment program with established policies on
communication, diagnostic and therapeutic interventions, and quality
improvement.4
Pediatricians and other appropriate consultants should work with
obstetricians to evaluate the potential risks and benefits of a given
therapy for the fetus and to formulate treatment recommendations that
consider the potential risks to the woman. Members of the health care
team should assist the parents in making an informed decision about
fetal therapy. This is best accomplished by communicating directly with
the parents to ensure that information is understood and that the
parents are aware of the broad range of possible outcomes for both the
pregnant woman and her fetus. This is extremely important because in
their desire to simplify their understanding of fetal interventions
parents may believe that a therapeutic intervention will result in
either the death of the fetus or complete correction of the problem.
Counseling should insure that parents understand the range of possible
outcomes between complete cure and death.5 Finally, the
health care team should be supportive and available to the family,
whatever their choice.
Fetal medical and surgical treatment is an evolving field. Many
techniques involving fetal intervention are of uncertain therapeutic efficacy. Some fetal therapeutic interventions, such as prenatal steroids to prevent hyaline membrane disease and zidovudine to prevent
the perinatal transmission of human immunodeficiency virus infection, are accepted practices of proven efficacy.6,7 Other interventions, such as fetal transfusion for hydrops secondary to
parvovirus infection, are common practices but are less certain in
their efficacy.8 Other fetal interventions, such as in
utero repair of congenital diaphragmatic hernia, currently are
considered research procedures and not standard medical
practices.9
If a fetal intervention is one of proven efficacy and has concomitant
low maternal risk, the physician should recommend the procedure and
emphasize, if necessary, the responsibility of the mother to accept
some personal risk for the potential benefit to her fetus. An example
of such a procedure is the use of intrauterine fetal transfusions to
prevent the complications of Rh isoimmunization. If the woman refuses
to undergo an intervention that poses a risk to her health and
well-being, her choice and assessment of risk should be respected.
When fetal surgical intervention is discussed with families, it
is important that procedures of unproven efficacy be clearly explained
as such. By definition, the outcome of experimental procedures is
uncertain; therefore, parents should not be pressured or made to feel
obligated to participate. Diagnostic and therapeutic procedures of
unproven efficacy should be undertaken with the voluntary informed
consent of the pregnant woman according to a clearly defined research
protocol that has been approved by the appropriate institutional review
board. A pregnant woman should be discouraged from placing herself at
undue risk where the potential benefit to the fetus is remote. Under
such circumstances, physicians may refuse to offer such an intervention
despite a pregnant woman's insistence that something be done.
The following three conditions must be met for a physician to consider
opposing the woman's refusal of a recommended intervention: 1) there
is reasonable certainty that the fetus will suffer irrevocable and
substantial harm without the intervention, 2) the intervention has been
shown to be effective, and 3) the risk to the health and well-being of
the pregnant woman is negligible. When these three conditions exist,
the woman should be informed that the decision creates a moral dilemma
for her physician and an attempt should be made to persuade (not
coerce) her to consent. It may be helpful, with the woman's
permission, to involve other family members in the decision. If refusal
persists, the physician may wish to inform the woman that her decision
may be unreasonable and that consultation with another physician, a
hospital ethics committee, or others within the institution would be
helpful.10
Finally, only in rare cases should a physician consider any further
action beyond that outlined above.11 Under no circumstances should a physician physically intervene without the
explicit consent of the pregnant woman before judicial review, regardless of her lack of physical resistance. If a physician feels
strongly that further intervention is necessary, judicial authorization
is absolutely required. However, given the potential adverse
consequences of forced medical or surgical procedures, court
intervention should be seen only as a last resort.12
The Academy cannot address interventions proposed solely for the
benefit of the pregnant woman. Unilateral action without a judge's
authorization is never appropriate, except perhaps in a genuine
emergency when the pregnant woman lacks decision-making capacity and
has not previously expressed an opinion about a proposed intervention
that is recommended by her physicians and/or other members of the
health care team to be in her best medical interests. In all other
circumstances, the pregnant woman's choice must be respected, and may
only be overridden when judicial authorization has been appropriately
obtained.13 If the pregnant woman currently lacks
decisional capacity, any prior expressions or family testimony about
her views must be carefully evaluated, preferably with the assistance
of an ethics committee or through judicial review, if they are to be
used to justify fetal therapy. In the absence of a previously expressed
opinion from the pregnant woman supporting fetal therapy, emergency
interventions solely for the benefit of the fetus are ethically
troubling and rarely, if ever, justified without judicial
authorization.
As the benefits and risks of fetal therapy are defined more clearly,
the physician's role in assisting families in making decisions may be
more clearly defined. Pregnant women almost always accept a
physician's recommendation for diagnostic and therapeutic fetal
interventions when provided evidence of proven effectiveness and low
maternal risk. However, all members of the health care team must be
aware of the possible conflicts between women and their fetuses created
by fetal interventions and must be prepared to address these ethical
dilemmas.
COMMITTEE ON BIOETHICS, 1998-1999
LIAISON REPRESENTATIVES
SECTION LIAISON
CONSULTANT
LEGAL CONSULTANT
ARTICLE
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Abstract
Article
References
Robert M. Nelson, MD, PhD, Chairperson
Jeffrey R. Botkin, MD, MPH
Marcia Levetown, MD
Kathryn L. Moseley, MD
John T. Truman, MD
Benjamin S. Wilfond, MD
Watson A. Bowes, MD
American College of Obstetricians and Gynecologists
Alessandra Kazura, MD
American Academy of Child and Adolescent Psychiatry
Ernest F. Krug, III, MD
American Board of Pediatrics
Donna A. Caniano, MD
Section on Surgery
Joel E. Frader, MD
Nancy M. P. King
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FOOTNOTES |
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The recommendations in this statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.
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REFERENCES |
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- Harrison MR. The fetus as a patient: historical perspective. In: Harrison MR, Globus MS, Filly RA, eds. The Unborn Patient: Prenatal Diagnosis and Treatment. 2nd ed. Philadelphia, PA: WB Saunders Company; 1991:3-7
- Johnsen DE The creation of fetal rights: conflicts with women's constitutional rights to liberty, privacy, and equal protection. Yale Law Journal. 1986; 95:599-625 [CrossRef][Medline]
- Nelson LJ, Milliken N Compelled medical treatment of pregnant women: life, liberty, and law in conflict. J Am Med Soc. 1988; 259:1060-1066
- Harrison MR. Professional considerations in fetal treatment. In: Harrison MR, Globus MS, Filly RA, eds. The Unborn Patient: Prenatal Diagnosis and Treatment. 2nd ed. Philadelphia, PA: WB Saunders Company; 1991:8-13
- Bealer JF, Raisanen J, Skarsgard ED, The incidence and spectrum of neurological injury after open fetal surgery. J Pediatr Surg. 1995; 30:1150-1154 [CrossRef][Medline]
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Kari MA,
Hallman M,
Eronen M,
Prenatal dexamethasone treatment in conjunction with rescue therapy of human surfactant: a randomized placebo-controlled multicenter study.
Pediatrics.
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Connor EM,
Sperling RS,
Gelber R,
Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment.
N Engl J Med.
1994;
331:1173-1180
[Abstract/Free Full Text] - Fairley CK, Smoleniec JS, Caul OE, Observational study of effect of intrauterine transfusions on outcome of fetal hydrops after parvovirus B19 infection. Lancet. 1995; 346:1335-1337 [CrossRef][Medline]
- Harrison MR, Adzick NS, Longaker MT, Successful repair in utero of a fetal diaphragmatic hernia after removal of herniated viscera from the left thorax. N Engl J Med. 1990; 322:1582-1584 [Medline]
- Chervenak FA, McCullough LB Ethical issues in recommending and offering fetal therapy. West J Med. 1993; 159:396-399 [Medline]
- Robertson JA Legal issues in fetal therapy. Semin Perinatol. 1985; 9:136-142 [Medline]
- American Medical Association Board of Trustees Legal interventions during pregnancy: court-ordered medical treatments and legal penalties for potentially harmful behavior by pregnant women. J Am Med Soc. 1990; 264:2663-2670
- American College of Obstetricians and Gynecologists. Patient Choice and the Maternal-Fetal Relationship. ACOG Committee Opinion No. 214. Washington, DC: ACOG; 1999
Pediatrics (ISSN 0031 4005). Copyright ©1999 by the American Academy of Pediatrics
Statement of retirement:
- AAP Publications Retired or Reaffirmed, October 2006
- American Academy of Pediatrics
Pediatrics 2007 119: 405.[Extract] [Full Text] [PDF]
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