Scott A Sullivan MD MSCR Maternal-Fetal Medicine MUSC October 12, 2010 Disclosures I have no disclosures or conflicts to report Disclosures – I am from MUSC! Learning Objectives Discuss NICHD Consensus Recommendations Review fetal physiology and EFM patterns Alternate technology – what works, what doesn’t and what is coming A bit of history… Marzac – 1620 First description of fetal heart tones Killian – 1640 Theory that heart tones = fetal health Kergaradec – 1818 Technique, viability Kennedy – 1833 Intra-partum monitoring Von Winkel – 1893 “Fetal Distress” definitions DeLee / Hillis – 1922 Fetoscope Matthews – 1940 Amplified fetoscope Edward H Hon, MD 1915 – 2009 Father of modern EFM 1958 First Viable EFM 1968 – Commercially available 1972 – First scalp electrode 1970’s – Coins deceleration terms 1975 – 20 % of labors used EFM EFM – Antepartum Testing Reactivity translates to a fetal death rate of < 5 /1000 Non-reactivity = fetal mortality rate of 40/1000 False positive rate 50-97(!) % Unless ominous, requires a confirmatory test Perinatal Death Rate PMR / 1000 live births 50 45 40 35 30 25 20 15 10 5 0 PMR 1940 1960 1980 2000 Use of Intra-partum EFM in the US 90 80 70 60 50 % Use 40 30 20 10 0 1975 1985 1995 2004 So How Have We Done? 1975 – 2010 Decreased fetal death incidence Cesarean section rate increased 110 % Cerebral palsy incidence unchanged Lawsuit rate / live-birth rate increased 340 % EFM vs. IA Cochrane Review – 2001 9 RCTs 18,561 patients No difference in Apgars, NICU, fetal death and cerebral palsy Reduction in seizures (RR 0.51 0.32-0.82) Increases in C/S and OVD Vintzileos – EFM vs IA 1995 Decrease in perinatal mortality (1/1000) 1996 Sensitivity – 97 % vs. 34 % Specificity – 84 % vs. 91 % PPV – 34 % vs. 22% NPV – 99.5 % vs. 95 % What’s the Problem? Subjective interpretation Technological limitations Lack of interventional guidelines Confusing terminology Terminology Gabbe vs. Williams “Short-Term”, “Beat to Beat” Lack of inter-rater reliability 1997 Consensus Inter-rater reliability 4 OBs – 22 % agreement (Nielson) 2 months later, re-reviewed 25 % changed their own interpretation 5 Obs – 29 % agreement (Beaulieu) NICHD Conference 2008 Series of meetings Jointly published in OBG, Pediatrics, Neonatology OBG 112(3);Sept 2008 661-666 Category I Must include ALL : Baseline 110-160 Moderate variability No late decelerations Early decelerations +/Accelerations +/- Category I Category I “Normal” “Highly Predictive of a normal fetal pH” No Action Required Physiology – Cat. I Physiology – Cat I Category III Absent variability, plus either Recurrent late decelerations Recurrent variable decelerations Bradycardia Sinusoidal pattern Category III Category III “Abnormal” “Predictive of abnormal acid-base status” Requires prompt intervention or delivery MANAGEMENT OF Cat III Discontinued oxytocin Begin oxygen 5-6 L/min Correct maternal hypotension Trendelenberg position Increase IV fluids Vasopressor (ephedrine 15 mg IV) Assess maternal oxygenation and acid/base status Terbutaline 0.25 mg SQ for in-utero resuscitation Environment Oxygen transfer can be disrupted at any of these points and can manifest as FHR deceleration (variable, late, prolonged) Lungs Heart Vasculature Uterus Placenta The degree of oxygen disruption is the important factor, not the point in the pathway at which oxygen transfer is disrupted Cord Oxygen transfer Fetus Hypoxemia Hypoxia Metabolic acidosis acidemia Fetal response Hypotension Potential Injury DECREASED UTEROPLACENTAL OXYGEN TRANSFER TO THE FETUS Chemoreceptor Stimulus Alpha Adrenergic Response With Acidemia Fetal Hypertension Baroreceptor Stimulus Myocardial Depression Parasympathetic Response Deceleration Without Acidemia Category II “Everything that not categorized as either Category I or III” Examples : Tachycardia, bradycardia with normal variability Absent variability, marked variability Lates + variability, unusual variables Category II Category II Category II FHR tracings are considered “indeterminate” Not predictive of abnormal fetal acid-base status but inadequate evidence to classify as Category I or III Requires evaluation and in-utero treatment if appropriate Requires continued surveillance and re-evaluation in context of clinical circumstances Variability Moderate FHR variability is HIGHLY predictive of the absence of metabolic acidemia at the time it is observed Parer JT J Maternal Fetal Neonatal Med 2006; 19:289-94 Low JA Obstet Gynecol 1999; 93:285-91 Williams KP Am J Obstet Gynecol 2003; 188:820-3 Elimian A Obstet Gynecol 1997; 89:373-6 MINIMAL OR ABSENT FHR VARIABILITY CNS depressants: Narcotics, Barbiturates, Benzodiazapines, Sedatives, Alcohol Parasympatholytics: Phenothiazines, Atropine General anesthetics Magnesium sulfate Fetal tachycardia due to maternal fever or fetal infection Preexisting neurological injury Fetal acidosis/acidemia NICHD 2008 - Pros Simple Better than 1998 More widely adopted ACOG buy-in NICHD 2008 - Cons No evidence the system is actually better Lack of actionable recommendations Category II ?? Does not fix problems of EFM A word about contractions Normal ≤ 5 contractions / 10 m Tachysystole ≥ 5 contractions / 10 m No hyperstimulation! How About < 32 weeks? No clear recommendations < 28 weeks, 50 % will be non-reactive 28-34 weeks, 15 % “10 x 10”? VAS? Artificial larynx used to stimulate the fetus Shortens time to reactivity 9.9 minutes 88 dB in the uterus Appears to be safe Reactive NST is just as reliable ? What’s New? It’s clear we need something better Fetal Pulse-Oximetry STAN Fetal Pulse Oximetry Same technology Oxygen saturation Mechanical problems FPO – Cochrane Review 2007 5 trials 7424 subjects Overall no decrease in cesarean rate, seizures Fetal scalp sampling? East CE, Cochrane Database 2007 STAN ST Waveform Analysis Automated analysis of ST segments Uses EFM + ST FDA approved - 2005 2001 Lancet - STAN Sweden RCT 4966 subjects STAN vs EFM alone Decrease in acidosis [RR 0.47 0.25-0.81] Decrease in OVD [RR 0.83 0.69-0.99] Amer-Wehlin, Lancet 2001 2006 BJOG - STAN RCT 1493 subjects Similar design No difference in acidosis No difference in cesarean section or OVD Ojala K, BJOG 2006 STAN – Cochrane Review 2006 4 trials, 9829 subjects No difference in C/S, OVD Decreased acidosis [RR 0.64 0.41 – 0.99] Decreased HIE [RR 0.33 0.11-0.91] Insufficient evidence to recommend Neilson, JP Cochrane Database 2006 Newer things…. Doppler? WAS – 2009 ANBLIR – 2010 (fuzzy logic, ANN) NIR photopleythysmography What does ACOG Say? Practice Bulletin 106 Endorses terminology High risk women need continuous EFM, for others it is optional No to FPO Thank You