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10/15/2015

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Issues Around Periviability: What is an Obstetrician to do?

Melissa Rosenstein, MD, MASUniversity of California, San Francisco

October 15, 2015

Disclosures• I have no financial disclosures to make

Objectives• Review new evidence and recent guidelines

regarding management of periviable birth• Explore the implications of changing

resuscitation thresholds• Present a framework for counseling parents

facing a periviable delivery• Focus on the experience and role of the

obstetrician in making decisions around resuscitation

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Further down the page…• 22-week-old babies did not survive without

medical intervention.– 78 cases with active treatment

• 18 survived• 7 of those did not have moderate or severe impairments. • 6 had serious problems such as blindness, deafness, severe

CP• 755 born at 23 weeks

– 542 cases active treatment• One-third survived• Half of the survivors had no significant problems.

Belluck P. New York Times. 2015 May 6, 2015. Rysavy MA, et al.. N Engl J Med. 2015 May 7;372(19):1801-11.

Rysavy MA, et al.. N Engl J Med. 2015 May 7;372(19):1801-11.

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Impairment Definitions• Severe impairment

– cognitive or motor score (Bayley-III) of less than 70 • (i.e., >2 SD below the scale mean)

– severe cerebral palsy– Gross Motor Function Classification System (GMFCS) level of 4 or 5

• (scale is 0-5)– bilateral blindness (visual acuity, <20/200– severe hearing impairment that cannot be corrected with bilateral

amplification.

• Moderate impairment – Bayley-III cognitive or motor score of 70 to 84

• (i.e., 1 to 2 SD below the scale mean), – moderate cerebral palsy– GMFCS level of 2 or 3.

Neurodevelopmental ImpairmentOutcomeAmongSurvivors

22N=18

23N=173

24N=598

25N=850

WithoutModerate or Severe NDI

7 (39%) 83 (47%) 327 (54%) 523 (61%)

Moderate NDI 5 (28%) 48 (28%) 160 (27%) 198 (23%)Severe NDI 6 (33%) 42 (24%) 111 (19%) 129 (15%)

Adapted from Supplemental Table 2, Rysavy MA, et al.. N Engl J Med. 2015 May 7;372(19):1801-11.

NICHD Joint Statement

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The small print• Between 22 - 25 weeks of gestation, there may be mitigating

factors (IUGR, malformations, aneuploidy, prolonged membrane rupture) that will affect the determination of viability

• The majority of survivors born at 25 6/7 weeks of gestation or less will incur major morbidities, regardless of gestational age at birth;

• Data from recent large studies suggest survival with delivery at 22 0/7 through 22 6/7 weeks of gestation to be 5-6%.

• With survival rates of approximately 26-28% and higher, infants born at 23 0/7 weeks through 25 6/7 weeks of gestation are generally considered potentially viable

Raju TN, Am J Obstet Gynecol. 2014 May;210(5):406-17.

NICHD Survival Data

From: Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012JAMA. 2015;314(10):1039-1051. doi:10.1001/jama.2015.10244

Infant Survival to Discharge

From: Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012JAMA. 2015;314(10):1039-1051. doi:10.1001/jama.2015.10244

Infant Survival to Discharge Without Major Morbidity

Infant Survival to Discharge

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Viability“In general, those born at 23 weeks of gestation should be considered potentially viable…”


Viability• “..viability marks the earliest point at which the State’s

interest in fetal life is constitutionally adequate to justify a legislative ban on nontherapeutic abortions.”

• “Whenever viability may occur, be it at 23–24 weeks, the standard at the time, or earlier, as may be the standard sometime in the future, the attainment of viability serves as the critical fact in abortion legislature.”

– Planned Parenthood of Southeastern PA. v Casey, 505 U.S. 833 (1992).

Viability - California• “the point in a pregnancy when, in the good

faith medical judgment of a physician, on the particular facts of the case before that physician, there is a reasonable likelihood of the fetus’ sustained survival outside the uterus without the application of extraordinary medical measures.”– CA HEALTH AND SAFETY CODE SECTION 123460-

123468

From NICHD statement“importantly, providers and families should understand that initiation of intervention to enhance outcomes (eg, antibiotics for preterm PROM, antenatal corticosteroid administration) does not mandate that all other aggressive interventions (eg. cesarean delivery) be undertaken regardless of clinical circumstances in the periviable period”


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Periviable Cesarean• Increased risk of uterine rupture in a

subsequent pregnancy– 1.8% (8/456) vs. 0.4% (38/10,505)

• Even excluding classical incisions• Mean gestational age in 2nd delivery: 36wks

• Inability to see or hold baby• Painful recovery during difficult time

Lannon SM et al, Obstet Gynecol. 2015 May;125(5):1095-100.

Effect of Method of Delivery• No difference in neurodevelopmental

outcomes at age 2• No difference in mortality • No difference in short-term morbidity

• Reserve CD for obstetric indications

Mercer BM, Semin Perinatol. 2013 12;37(6):417-21.Običan SG et al, Obstet Gynecol. 2015 10;213(4):578.e1,578.e4.

AAP Guide to Counseling• “In addition, whereas previous publications

may have provided specific recommendations based on the anticipated gestational age, this statement emphasizes the limitations of that approach and the need to individualize counseling. “

Cummings J, COMMITTEE ON FETUS AND NEWBORN. Pediatrics. 2015 Aug 31.

Limitations of Gestational Age Cutoffs• Variable and rapid rate of fetal development

during the early third trimester • Inaccuracy of gestational dating• Other factors

– Gender– Steroids– Multiples– Birthweight


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Components of Counseling• assessment of risks• communication of those risks• ongoing support


What information to give?• Institutional vs. Local vs. National?

– Depends on patterns of resuscitation– Depends on numbers of babies

• Range rather than specific number

• Written/Visual aides requested by parents– Consider literacy levels

Gaucher N, Payot A. Paediatr Child Health. 2011;16(10): 638–642

NICHD NRN calculator

Arnold C, Tyson JE. Semin Perinatol. 2014 2;38(1):2-11https://neonatal.rti.org

Hope• Communicating only negative information

perceived as having “given up”• Lack of optimism leads to mistrust and

adversarial relationship• Acknowledge grief and fear• Physicians who express emotion more likely to

be perceived as compassionate and hopeful

Grobman WA et al, Obstet Gynecol. 2010 May;115(5):904-9.Boss RD et al, Pediatrics. 2008 Sep;122(3):583-9.

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“What would you do”• Use as bridge to inquire about patient

– Attitudes– Fears– Preferences– Values– Goals

Tucker Edmonds B et al, Patient Educ Couns. 2015 Jan;98(1):49-54.

Importance of Team Counseling• Divergent estimates given on likelihood of

survival and disability• Different definitions of “intact survival”• Specialists defer to each other on

management questions (steroids)

Tucker Edmonds B et al, J Perinatol. 2015 May;35(5):344-8. Tucker Edmonds B et al, J Matern Fetal Neonatal Med. 2014 Nov 14:1-5.

Patient Desires• Team approach• Time to think• Multiple visits• Expressions of sympathy• Hope• Range of numbers• Ongoing support

Srinivas SK. Semin Perinatol. 2013 12;37(6):426-30. Manley BJ et al, Pediatrics. 2010; 125(3).

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UCSF PolicyResuscitation at limits of viability• >26 weeks – Universal resuscitation (unless lethal

anomaly or other reason not viable)• 25+0 – 25+6 – Resuscitation is default option, with

parental choice for comfort care or resuscitation• 24+0 – 24+6 – Do not recommend resuscitation.

Parental choice for comfort care or resuscitation, based on individual risk factors

• 23+0 – 23+6 – Strong recommendation against resuscitation. Parental choice to be considered IF meets ALL mandatory criteria:

UCSF Criteria for Resuscitation at 23wMANDATORY CRITERIA IN ORDER TO BE OFFERED RESUSCITATION AT 23 +0 -23+6[ ] No major congenital anomalies [ ] No chorioamnionitis on presentation, clinical diagnosis made by obstetrics team [ ] Greater than 24 hours from first dose of BMZ[ ] Category 1 or 2 Fetal Heart Rate Tracing; no evidence of category III tracing on presentation[ ] No prior or current laminaria placement

RELATIVE CONTRAINDICATIONS TO RESUSCITATION AT 23 0/7 – 23 6/7, unless otherwise specified[ ] multiple gestation pregnancy[ ] IUGR (<10%ile)[ ] Unexplained or prolonged oligohydramnios

Counseling Team• Pregnant patient, with partner, intended

parent(s) or other anticipated guardian, if applicable

• MFM Fellow, and/or MFM or OB attending (or Chief OB resident)

• Neonatology Fellow and/or Attending • L&D bedside RN• ICN triage RN• Social worker, as available

Talking Points• Use name and gender of baby• Details vs. Big Picture• NEJM Survival Stats• Obstetric options• Neonatal options• Hospital Course

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Next Steps

• Northern California Periviability Collaborative • Data collection• Individualize decision-making

Thank you!!

References 1. Ancel PY, Goffinet F, EPIPAGE-2 Writing Group, Kuhn P, Langer B, Matis J, et al. Survival and morbidity of preterm children born at 22 through 34 weeks' gestation in France in 2011: results of the EPIPAGE-2 cohort study. JAMA Pediatr. 2015 Mar;169(3):230-8. 2. Arnold C, Tyson JE. Outcomes following periviable birth. Semin Perinatol. 2014 2;38(1):2-11. 3. Belluck P. Premature Babies May Survive at 22 Weeks if Treated, Study Finds. New York Times. 2015 May 6, 2015. 4. Boss RD, Hutton N, Sulpar LJ, West AM, Donohue PK. Values parents apply to decision-making regarding delivery room resuscitation for high-risk newborns. Pediatrics. 2008 Sep;122(3):583-9. 5. Chervenak FA, McCullough LB. Ethical issues in periviable birth. Semin Perinatol. 2013 12;37(6):422-5. 6. Cummings J, COMMITTEE ON FETUS AND NEWBORN. Antenatal Counseling Regarding Resuscitation and Intensive Care Before 25 Weeks of Gestation. Pediatrics. 2015 Aug 31. 7. Dupont-Thibodeau A, Barrington KJ, Farlow B, Janvier A. End-of-life decisions for extremely low-gestational-age infants: why simple rules for complicated decisions should be avoided. Semin Perinatol. 2014 Feb;38(1):31-7. 8. Gaucher N, Payot A. From powerlessness to empowerment: Mothers expect more than information from the prenatal consultation for preterm labour. Paediatr Child Health. 2011 Dec;16(10):638-42. 9. Grobman WA, Kavanaugh K, Moro T, DeRegnier RA, Savage T. Providing advice to parents for women at acutely high risk of periviable delivery. Obstet Gynecol. 2010 May;115(5):904-9. 10. Haywood JL, Goldenberg RL, Bronstein J, Nelson KG, Carlo WA. Comparison of perceived and actual rates of survival and freedom from handicap in premature infants. Am J Obstet Gynecol. 1994 Aug;171(2):432-9. 11. Kaempf JW, Tomlinson MW, Campbell B, Ferguson L, Stewart VT. Counseling pregnant women who may deliver extremely premature infants: medical care guidelines, family choices, and neonatal outcomes. Pediatrics. 2009 Jun;123(6):1509-15. 12. Kariholu U, Godambe S, Ajitsaria R, Cruwys M, Mat-Ali E, Elhadi N, et al. Perinatal network consensus guidelines on the resuscitation of extremely preterm infants born at <27 weeks' gestation. Eur J Pediatr. 2012 Jun;171(6):921-6. 13. Lannon SM, Guthrie KA, Vanderhoeven JP, Gammill HS. Uterine rupture risk after periviable cesarean delivery. ObstetGynecol. 2015 May;125(5):1095-100. 14. Lantos JD, Meadow W. Variation in the treatment of infants born at the borderline of viability. Pediatrics. 2009 Jun;123(6):1588-90.

References, Cont’d15. Litmanovitz I, Reichman B, Arnon S, Boyko V, Lerner-Geva L, Bauer-Rusak S, et al. Perinatal factors associated with active intensive treatment at the border of viability: a population-based study. J Perinatol. 2015 Sep;35(9):705-11. 16. Manley BJ, Dawson JA, Kamlin CO, Donath SM, Morley CJ, Davis PG. Clinical assessment of extremely premature infants in the delivery room is a poor predictor of survival. Pediatrics. 2010 Mar;125(3):e559-64. 17. Marlow N. The elephant in the delivery room. N Engl J Med. 2015 May 7;372(19):1856-7. 18. Mercer BM. Mode of delivery for periviable birth. Semin Perinatol. 2013 12;37(6):417-21. 19. Moore GP, Lemyre B, Barrowman N,Daboval T. Neurodevelopmental outcomes at 4 to 8 years of children born at 22 to 25 weeks’ gestational age: A meta-analysis. JAMA Pediatrics. 2013 October 1;167(10):967-74. 20. Običan SG, Small A, Smith D, Levin H, Drassinower D, Gyamfi-Bannerman C. Mode of delivery at periviability and early childhood neurodevelopment. Obstet Gynecol. 2015 10;213(4):578.e1,578.e4. 21. Raju TN, Mercer BM, Burchfield DJ, Joseph GF,Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Am J Obstet Gynecol. 2014 May;210(5):406-17. 22. Ramsay SM, Santella RM. The definition of life: a survey of obstetricians and neonatologists in New York City hospitals regarding extremely premature births. Matern Child Health J. 2011 May;15(4):446-52. 23. Rysavy MA, Li L, Bell EF, Das A, Hintz SR, Stoll BJ, et al. Between-hospital variation in treatment and outcomes in extremely preterm infants. N Engl J Med. 2015 May 7;372(19):1801-11. 24. Soll RF. Progress in the Care of Extremely Preterm Infants. JAMA. 2015 Sep 8;314(10):1007-8. 25. Srinivas SK. Periviable births: Communication and counseling before delivery. Semin Perinatol. 2013 12;37(6):426-30. 26. Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, et al. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. 27. Tucker Edmonds B, McKenzie F, Panoch JE, Barnato AE, Frankel RM. Comparing obstetricians' and neonatologists' approaches to periviable counseling. J Perinatol. 2015 May;35(5):344-8. 28. Tucker Edmonds B, McKenzie F, Panoch JE, Frankel RM. Comparing neonatal morbidity and mortality estimates across specialty in periviable counseling. J Matern Fetal Neonatal Med. 2014 Nov 14:1-5. 29. Tucker Edmonds B, McKenzie F, Panoch JE, Wocial LD, Barnato AE, Frankel RM. "Doctor, what would you do?": physicians' responses to patient inquiries about periviable delivery. Patient Educ Couns. 2015 Jan;98(1):49-54.

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