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Robert H. Debbs,DO, FACOOGDirector, MFM Network
Professor of Clinical OB/GYNPerelman School of Medicine
University of Pennsylvania
Periviable Gestation: New Data, New Ethics?
22
Disclosures
w No financial disclosuresw I’m a maternal-fetal medicine specialistw Former member of ACOG/ACOOG Ethics
Committeew I’m pro-choicew I offer termination of pregnancy servicesw I’m not a trained ethicist, but practice medical
ethics every day
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44
Case
w 24 y/o G2P1 presents at 24 weeks with preterm labor. w Cervix is 3cm dilated.w Patient given steroids, antibiotics, MgSO4.w EFW 650g, female fetusw Counseled by MFM and NICU
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Case
w Patient declines all further obstetrical interventions• Does not want fetal monitoring• Does not want cesarean section for non-reassuring
fetal testing
w Patient requests non-resuscitation if baby born alive.
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Case # 2
w A 42 y/o G1P0 comes in at 23w + 3d, IVF pregnancy, in labor 6cm dilated.
w Fetus with known Trisomy 18. w She says she wants everything done.
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Joint Workshop
Joint workshop 1. Society for Maternal–Fetal Medicine, 2. The Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD)
3. Section on Perinatal Pediatrics of the American Academy of Pediatrics,
4. American College of Obstetricians and Gynecologists
Definition- periviable birth from 20 0/7 weeks to 25 6/7 weeks of gestation
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Are Physicians Biased?
w Do we give information that is based solely on the evidence?• Or is it influenced by our own values?
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The Ethical Question
wWhen (if ever) is it appropriate to override parental wishes in periviable gestations?
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2 Cases
Patient #1
w Preterm labor at 24 weeksw Wants nothing done
Patient #2
w Preterm labor at 23 weeksw Trisomy 18w Wants everything done
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Descriptive Ethics
wWhat do people think?
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Survey Results
wAt what gestational age should babies be routinely resuscitated?
(even against parental wishes)
wResuscitation should be mandatory.
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Survey Results
w N = 100• 18 OB Generalists• 20 MFM• 20 Other subspecialists, PEDS/NEO• 20 Residents ( OB, PEDS)• 10 Fellows ( MFM)• 12 Nurses
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Resuscitation Should Be Mandatory(Even if Parents Don’t Want it)
%
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Resuscitation Should NOT be Done(Even if Parents Wish It)
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Normative Ethics
w What should we do?
w Is it permissible to overrule parents’ wishes?w Under what circumstances?
w Why?
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Parental Authority
In order to determine when it is permissible to overrule the parents, we must determine why it is permissible.
– Mark Mercurio, 2006 Journal of Perinatology(2006) 26, 452–457. doi:10.1038/sj.jp.7211547
– Parental authority, patient's best interest and refusal of resuscitation at borderline gestational age
– MR Mercurio11Department of Pediatrics, Yale University School of Medicine, Yale University Interdisciplinary Bioethics Center, New Haven, CT, USA
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What makes something Ethical?
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What makes something Ethical?
w Frameworks• Utilitarianism• Kantian (duty-based) Ethics• Communitarian Ethics• Feminist Ethics• Principlism
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What makes something Ethical?
w Principles of Bioethics• Autonomy• Beneficence• Non-Maleficence• Justice
• Veracity• Confidentiality• Respect for Persons• Quality of Life• Sanctity of Life
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Autonomy
w Self Governancew Self Determination
w Can a newborn be said to have these things?
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Who Decides for Those Who Can’t Decide?
w Adults who once had decision-making capacity• Advance Directives• Substituted Judgment
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Who Decides for Those Who Can’t Decide?
w What about children?
w Best Interests Standard
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Best Interests Standard
w A balance of beneficence and non-maleficence based duties• Overall benefit to the patient outweighs the overall
burden
• Do as much good as you can, causing as little harm as is necessary
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Best Interests Standard
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Best Interests
w The Best Interests Standard tells us WHAT we can do
w But if there is more than one reasonable choice, someone has to make a choice
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Who Decides?
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Parental Choice
w Presumption that parents will make good choices for their children.
w They have their children’s best interests at heart.
w Not an absolute: • We don’t let parents make any decision they want
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Bad Parental Choice
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Not all parental choices are acceptable
w We let parents make choices for their children, but we draw the line when those choices are clearly notin the child’s best interest.
w Abuse, neglect
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Our Job
w Help parents make good decisions for their children
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What do Parents Need to Make Good Decisions for their Children?
w Good Ethics Require Good Facts
w In order for parents to make good decisions for their children, they need good information and counseling
w Informed Consent
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Informed Consent/Refusal
w Parents need accurate and adequate information about neonatal outcomes to make decisions that will be in their child’s best interest.
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Informed Consent
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Periviability Counseling
w Survival Dataw Complication Dataw Effect of mode of deliveryw Effect on future
pregnanciesw Prolonged NICU stayw What intervention looks
likew What non-intervention
looks like
w Prognosis for staying pregnant
w Risks of remaining pregnant
w Impact on family of prolonged NICU stay
w Pregnancy termination options
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Counseling about Prematurity
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Informed Consent
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Difficulties in Informed Consent
w Constraints of Time• Often clinical decision-making under duress
– Pain/Anxiety of labor– Abnormal fetal testing– Clinical emergencies (hemorrhage)
w Constraints of Language• Chance vs. risk• Death vs. survival• Intact vs. damaged• Disability vs. challenge
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Watch Your Language!
w “No babies survive at our institution before 23 weeks.”
w “The chance of your baby being normal is quite low.”
w Most women in your situation do _____.
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Demeanor
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Comprehension
w How do we know parents truly understand the information we’ve given them?
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Ensuring Comprehension
w Do you understand?w Does that make sense?
w Tell me in your own words what I’ve said, just so I can be sure I’ve been clear.
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Good Ethics Require Good Facts
w How do we know what the outcome will be?
w How sure are we that we know what we think we know?
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NICHD 2008
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NICHD Calculator
http://www.nichd.nih.gov/about/org/der/branches/ppb/programs/epbo/pages/epbo_case.aspx
The estimated outcomes are probabilities derived from data obtained from 4,446 infants born at 400–1,000 g without major congenital anomalies who were admitted to a level III or IV Neonatal Research Network hospital between 1998 and 2003 and monitored until 18–22 months’ corrected age.
https://neonatal.rti.org
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An Example
w24 week Malew600gwTwinwNo steroids
• Survival: 27%• Survival without
profound disability: 15%
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NICHD Predictors
w Gestational Agew Birth weightw Sexw Pluralityw Steroid Administration`
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Gestational Age is Precise
w X weeks and Y days
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Is Gestational Age Accurate?
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It’s hard to be accurate when…
The OB tells you the pregnancy is 24 weeks.
BUT:
It all depends on the dating!
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It’s hard to be accurate when…
24 weeks equals:…24 weeks if dating by IVF…23-25 weeks if dating by early U/S…22-26 weeks if dating only by LMP
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Accuracy of Dating
22wks 24wk 26wks 28wks 30wks
IVF12wk U/S
20 wk U/S
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Estimated Fetal Weight
w Can be off by 10-15%w 650g
• +/- 15%– 552g -747g
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We Are Not Rocket Scientists
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NICHD Paramenters
w Individual parameters not important in and of themselves.
w But overall prognosis is.
Gestational AgeSexBirthweightPluralitySteroids
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Prognosis, prognosis, prognosis
w The morally relevant question is not:Do fetuses survive at this GA?
OrDo fetuses survive at this weight?
But:
What is the prognosis for fetuses like this particular one?
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Prognosis, prognosis, prognosis
w The morally relevant question is not:Do fetuses survive at this GA?
OrDo fetuses survive at this weight?
But:
What is the prognosis for fetuses like this particular one?
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Imagine 2 More Babies
Baby 1
w 24 wk femalew 680gw s/p steroidsw singleton
Baby 2
w 25 wk malew 700gw No steroidsw singleton
Predicted Survival:70%
Predicted Survival:60%
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Gestational Age is Not Everything
w Making distinctions based on gestational age doesn’t seem morally justifiable.
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Epistemology
w The study of how we know things
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How do we know that what we think we know is true?
What is survival at 22 weeks?• NICHD data: 6%
– But resuscitation only attempted in 19%...
• Perhaps with more aggressive treatment, survival would be better?
• Do 22 week babies die because we don’t try to save them?
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What do you do?
1.Stoll BJ, NICHD NRB Pediatrics, 20102.Costeloe KL, EPICure studies, BMJ, 20123.Ishii, Japanese Neonatal Network, Pediatrics, 20134.Rysay et al, NICHD NRB NEJM, 2015
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2010 NICHD
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Japanese Cohort
w Itabashi et al. Pediatrics 2009w 97 infantsw Survival at 22 weeks…
34%!
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NEJM 2015
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Rysavy et al, NEJM 2015
w Infants born at 24 NICHD centersw 4987 infants
• Survival• Neurodevelopmental Impairment at 18-22 mos
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% of Infants Treated Actively by GA
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Impact of Which Hospital You’re At
GA
Impact Hospital of Delivery on
Survival
P
22-23wk 78% <0.001
24 wk 22% <0.01
25 wk 1% <0.26
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23 week survival
Hospital Rate of Intervention
% Survival
Rysavy et al. 2015
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What impacts survival?
w NICHD Parameters• Sex• Birthweight• Gestational Age• Plurality• Steroid Exposure
w Other Factors• Which Hospital?• How aggressive are the OB/GYNs?• How aggressive are the Neonatologists?• What are the patterns of withdrawal of care in the
NICU?
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Survival: Survey Data
0
10
20
30
40
50
60
70
80
20 weeks
21 weeks
22 weeks
23 weeks
24 weeks
25 weeks
26 weeks
NICUOB
= NICHD Data
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Survival Without Neuro Disability
05
101520253035404550
20 weeks
21 weeks
22 weeks
23 weeks
24 weeks
25 weeks
26 weeks
NICUOB
= NICHD Data
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What about the Law?
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Miller v HCA
w 23 week pregnancy in Texas in 2003w Parents requested non-resuscitationw DOC went against parents wishes at the delivery
w Court ruled that DOC has this prerogative• Delivery is an emergency situation• Gave great discretion to physicians• Are the courts biased as some physicians? Of
course!!!
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Show Me The Baby on DOL 7!
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Where We Are
w If parents are to make good decisions for their children, they need good information.
w We face difficulties providing that in a timely, unbiased, accurate and precise manner.
w Difficulty assessing parents’ understanding.
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Where We Are
w Parents need to know about prognosis• Gestational age is just one piece of the puzzle
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Assuming Parents are well Informed…w Can they make any choice they want?
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Parental Standards
w Best Interestsw Family’s Interests
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What are the Best interests?
w Survival?w Survival free of severe disability?w Survival free of any disability?w A painless, brief NICU admission?
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What are the Best Interests?
w How high does the chance of survival have to be to make resuscitation in the child’s best interests?
w How high does the chance of survival without profound disability have to be to make resuscitation in the child’s best interests?
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Quality of Life
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Quality of Life
w Sufficient functioning to engage in life tasks that bring enjoyment and satisfaction
w Capacity for symbolic interaction and communication
w Potential for cognitive development and interaction
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Do we undervalue premature babies?
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Janvier, et al. 2008
w Anonymous Questionnaire• 8 patients with potential poor neuro sequelae
– Preterm infant– Newborns– Children– Adults
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Janvier, et al. 2008
w Premature infants compared to children or adults with similar chances of survival or similar prognoses
• Premature babies fared worse– Less likely to be resuscitated– More likely to be offered comfort care
Janvier, et al. Pediatrics 2008
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Why Are Preemies Treated Differently?
w Reproductive choice colors decisions at periviability
w Diminished sense of duty to premature infantw Lack of personhood
• Or less personhood
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Really?
VALUE
AGE
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VALUE
AGE
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Children are not Preemies
When we treat a child with an illness, parents hope to return the child to a previous state of health.
Health HealthIllness
Perhaps the older the child, the more willing parents are to attempt interventions to NOT LOSE that child.
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Children are not Preemies
When we treat a child for prematurity, parents do not hope for a return to a child that already exists, but they hope for a different, older, healthier child.
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Disability
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Uncertainty
w Is it in the best interests of the child to face an uncertain future?
w If everything works out well, then we’re happy.
w But if outcomes are poor…
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Rights
w Does the child have a right to life?• So any chance of survival should be sought?
w Or a right to a good life?w Or a right to merciful treatment?w Or a right to a decent existence on the path to
survival?
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Should Other Factors Matter?
w The interests of others• Parents’ interests• Other siblings• Society
• Do we include these in making decisions for 3 year-olds?– What is the moral distinction?
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WHAT ABOUT THE MOTHER?
w 1. STEROIDS, MAG FOR NEUROPROTECTION-LITTLE RISKSw 2. CLASSICAL CESAREAN SECTION
• UTERINE RUPTURE IN FUTURE, ACCRETA, HEMORRHAGE
• THROMBOSIS, DEATH• FUTURE REPRODUCTIVE RISKS• INFECTION
w EXPECTANT MANAGEMENT IN PPROM• MATERNAL SEPSIS, HYSTERECTOMY,
HEMORRHAGE, w EXPECTANT MANAGEMENT IN PEC WITH SEVERE
FEATURES• HELLP, DIC, PULMONARY EDEMA, DEATH, CVA
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Cognitive Dissonance on the Labor Floorw In one room: a 22 week laboring patient, wanting
“everything done”
w In the next room: 23 week induction for PPROM; the parents want non-resuscitation
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AAP
w “Physicians should not be forced to undertreat or overtreat an infant when, in their best medical judgment, the treatment is not in compliance with the standard of care for that infant.”
○ AAP Committee on Fetus and Newborn “The Initiation or Withdrawal of Treatment of High-Risk Newborns”
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More AAP
w If physicians believe there is no chance of survival, resuscitation should not be initiated
w “When the physicians’ judgment is that a good outcome is reasonably likely, clinicians should initiate resuscitation…”
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We have to draw lines
22wks 24wk 26wks 28wks 30wks
And even though GA is not a perfect predictor of outcome, it is an easy way to draw lines
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Resuscitation Should Be Mandatory(Even if Parents Don’t Want it)
%
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MEDICINE
110088
How We Can Do Better
w Clinicians should discuss with parents whether their goal is optimizing survival or minimizing suffering.
w The approach to antenatal and post delivery care may differ dramatically depending on parental preferences regarding resuscitation.
w A recommendation regarding assessment for resuscitation is not meant to indicate that resuscitation should always either be undertaken or deferred, or that every possible intervention need be offered.
w A stepwise approach concordant with neonatal circumstances and condition and with parental wishes is appropriate.
w Care should be reevaluated regularly and potentially redirected based on the evolution of the clinical situation. Assessment at birth, for example, may include confirmation that comfort measures are most appropriate.
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HOW WE CAN DO BETTER
w A decision to proceed with resuscitation always should be informed by individual circumstances, including specific clinical issues • estimated fetal weight AND most precise estimate of
gestational age), • family values and wishes, • ongoing evaluation of fetal or neonatal condition. • informed by local institutional policy and relevant laws• guidelines offer recommendations with regard to the gestational
ages at which assessment for resuscitation rather than resuscitation itself should be undertaken.
• Such assessment is meant in most cases to refer to that provided by neonatologists or other pediatric providers, separate from that offered by obstetrician–gynecologists and other obstetric providers.
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Humility
w Admit when we don’t know thingsw At best, we can only provide a range of prognoses
based on incomplete information
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Interdisciplinary Care
w Consensus• Hospital policy• MFM and Neonatology
w As much consistency as possible• Plan should not change with every shift change
w Counsel together• MFM/OB and Neonatology together
wA decision not to undertake resuscitation of a liveborn infant should not be seen as a decision to provide no care, but rather a decision to redirect care to comfort measures.
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Consensus
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Deliberative Model of Care
w Exploration of patients’ goals and valuesw Help patients understand options in terms of their
goals and valuesw May involve moral persuasion
– Emmanuel and Emmanuel, JAMA 1992
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Informed Consent/Refusal
w Give patients the information they need to make good decisions for themselves and their children
w What is important is prognosis• Gestational age is often, but not always, a good proxy
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Baby Doe Regulations
w Child Abuse Prevention and Treatment Act (CAPTA)• Require treatment unless:
– Chronically and irreversibly comatose– Treatment merely prolonging dying– Treatment not effective in ameliorating or
correcting all the infant’s life-threatening conditions
– Treatment would be virtually futile in terms of survival
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One Model
SMFM/ACOG
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Role Modeling
w Fellowsw Residentsw Students
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Take Home Message
w Do the right thingw Good ethics require good facts
w All cut-offs are arbitrary• Distinctions should be morally relevant
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Question Authority
wSocrates
“The unexamined life is not worth living.”
“Not life, but good life, is to be chiefly valued.”
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THANK YOU!
