10/15/2015 Disclosures • I have no financial disclosures to make Issues Around Periviability: What is an Obstetrician to do? Melissa Rosenstein, MD, MAS University of California, San Francisco October 15, 2015 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 1
10/15/2015 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. 2
10/15/2015 Impairment Definitions Neurodevelopmental Impairment • Severe impairment Outcome 22 23 24 25 – cognitive or motor score (Bayley-III) of less than 70 Among N=18 N=173 N=598 N=850 • (i.e., >2 SD below the scale mean) Survivors – severe cerebral palsy Without 7 (39%) 83 (47%) 327 (54%) 523 (61%) – Gross Motor Function Classification System (GMFCS) level of 4 or 5 Moderate or • (scale is 0-5) Severe NDI – bilateral blindness (visual acuity, <20/200 Moderate NDI 5 (28%) 48 (28%) 160 (27%) 198 (23%) – severe hearing impairment that cannot be corrected with bilateral Severe NDI 6 (33%) 42 (24%) 111 (19%) 129 (15%) 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. Adapted from Supplemental Table 2, Rysavy MA, et al.. N Engl J Med. 2015 May 7;372(19):1801-11. NICHD Joint Statement 3
10/15/2015 The small print NICHD Survival Data • 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. From: Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012 From: Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012 JAMA. 2015;314(10):1039-1051. doi:10.1001/jama.2015.10244 JAMA. 2015;314(10):1039-1051. doi:10.1001/jama.2015.10244 Infant Survival to Discharge Infant Survival to Discharge Infant Survival to Discharge Without Major Morbidity 4
10/15/2015 Viability Viability • “..viability marks the earliest point at which the State’s “In general, those born at 23 weeks of gestation interest in fetal life is constitutionally adequate to should be considered potentially viable…” 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). Raju TN, Am J Obstet Gynecol. 2014 May;210(5):406-17. Viability - California From NICHD statement • “the point in a pregnancy when, in the good “importantly, providers and families should faith medical judgment of a physician, on the understand that initiation of intervention to particular facts of the case before that enhance outcomes (eg, antibiotics for preterm physician, there is a reasonable likelihood of PROM, antenatal corticosteroid administration) the fetus’ sustained survival outside the does not mandate that all other aggressive uterus without the application of interventions (eg. cesarean delivery) be extraordinary medical measures.” undertaken regardless of clinical circumstances – CA HEALTH AND SAFETY CODE SECTION 123460- in the periviable period” 123468 Raju TN, Am J Obstet Gynecol. 2014 May;210(5):406-17. 5
10/15/2015 Periviable Cesarean Effect of Method of Delivery • Increased risk of uterine rupture in a • No difference in neurodevelopmental subsequent pregnancy outcomes at age 2 – 1.8% (8/456) vs. 0.4% (38/10,505) • No difference in mortality • Even excluding classical incisions • No difference in short-term morbidity • Mean gestational age in 2 nd delivery: 36wks • Reserve CD for obstetric indications • Inability to see or hold baby • Painful recovery during difficult time Mercer BM, Semin Perinatol. 2013 12;37(6):417-21. Običan SG et al, Obstet Gynecol. 2015 10;213(4):578.e1,578.e4. Lannon SM et al, Obstet Gynecol. 2015 May;125(5):1095-100. Limitations of Gestational Age Cutoffs AAP Guide to Counseling • “In addition, whereas previous publications • Variable and rapid rate of fetal development may have provided specific recommendations during the early third trimester • Inaccuracy of gestational dating based on the anticipated gestational age, this statement emphasizes the limitations of that • Other factors approach and the need to individualize – Gender counseling. “ – Steroids – Multiples – Birthweight Cummings J, COMMITTEE ON FETUS AND NEWBORN. Pediatrics. 2015 Aug 31. Cummings J, COMMITTEE ON FETUS AND NEWBORN. Pediatrics. 2015 Aug 31. 6
10/15/2015 Components of Counseling What information to give? • assessment of risks • Institutional vs. Local vs. National? – Depends on patterns of resuscitation • communication of those risks – Depends on numbers of babies • ongoing support • 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 Cummings J, COMMITTEE ON FETUS AND NEWBORN. Pediatrics. 2015 Aug 31. NICHD NRN calculator 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 Arnold C, Tyson JE. Semin Perinatol. 2014 2;38(1):2-11 Grobman WA et al, Obstet Gynecol. 2010 May;115(5):904-9. https://neonatal.rti.org Boss RD et al, Pediatrics. 2008 Sep;122(3):583-9. 7
10/15/2015 “What would you do” Importance of Team Counseling • Use as bridge to inquire about patient • Divergent estimates given on likelihood of – Attitudes survival and disability – Fears • Different definitions of “intact survival” – Preferences • Specialists defer to each other on – Values management questions (steroids) – Goals Tucker Edmonds B et al, J Perinatol. 2015 May;35(5):344-8. Tucker Edmonds B et al, Patient Educ Couns. 2015 Jan;98(1):49-54. 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 Manley BJ et al, Pediatrics. 2010; 125(3). Srinivas SK. Semin Perinatol. 2013 12;37(6):426-30. 8
10/15/2015 UCSF Policy UCSF Criteria for Resuscitation at 23w MANDATORY CRITERIA IN ORDER TO BE OFFERED RESUSCITATION AT 23 +0 - Resuscitation at limits of viability 23+6 • >26 weeks – Universal resuscitation (unless lethal [ ] No major congenital anomalies [ ] No chorioamnionitis on presentation, clinical diagnosis made by obstetrics anomaly or other reason not viable) team • 25+0 – 25+6 – Resuscitation is default option, with [ ] Greater than 24 hours from first dose of BMZ parental choice for comfort care or resuscitation [ ] Category 1 or 2 Fetal Heart Rate Tracing; no evidence of category III tracing on presentation • 24+0 – 24+6 – Do not recommend resuscitation. [ ] No prior or current laminaria placement Parental choice for comfort care or resuscitation, RELATIVE CONTRAINDICATIONS TO RESUSCITATION AT 23 0/7 – 23 6/7 , based on individual risk factors unless otherwise specified • 23+0 – 23+6 – Strong recommendation against [ ] multiple gestation pregnancy [ ] IUGR (<10%ile) resuscitation. Parental choice to be considered IF [ ] Unexplained or prolonged oligohydramnios meets ALL mandatory criteria: Counseling Team Talking Points • Pregnant patient, with partner, intended • Use name and gender of baby parent(s) or other anticipated guardian, if • Details vs. Big Picture applicable • NEJM Survival Stats • MFM Fellow, and/or MFM or OB attending (or • Obstetric options Chief OB resident) • Neonatology Fellow and/or Attending • Neonatal options • L&D bedside RN • Hospital Course • ICN triage RN • Social worker, as available 9
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