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New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them Mary E. D’Alton, MD Willard C. Rappleye Professor Chair, Department of Obstetrics and.

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Presentation on theme: "New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them Mary E. D’Alton, MD Willard C. Rappleye Professor Chair, Department of Obstetrics and."— Presentation transcript:

1 New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them Mary E. D’Alton, MD Willard C. Rappleye Professor Chair, Department of Obstetrics and Gynecology Columbia University College of Physicians and Surgeons New York, New York All the possibilities of modern medicine

2 Intrapartum FHR monitoring is the single most common obstetric procedure in the US, impacting the lives of almost 4 million mothers and babies every year Background

3 Identified “poor communication of abnormal FHR patterns” as a leading risk factor for preventable perinatal injury Recommended that hospitals educate nurses, residents, nurse midwives, and physicians to use standardized terminology to communicate abnormal fetal heart rate tracings. The commission further recommended that healthcare organizations develop clear guidelines for interpretation of FHR patterns… Joint Commission Sentinel Event Alert: Issue 30 –July 21, 2004

4 The purpose of the National Institutes of Health research planning workshops is to assess the research status of clinically important areas. This article reports on a workshop whose meetings were held between May 1995 and November 1996 in Bethesda, Maryland, and Chicago, Illinois. Its specific purpose was to develop standardized and unambiguous definitions for fetal heart rate tracings. The recommendations for interpreting fetal heart rate patterns are being published here and simulatneously by the Journal of Obstetric, Gynecologic, and Neonatal Nursing. (Am J Obstet Gynecol 1997; 177: ).

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6 Efficacy: Cochrane Review 12 clinical trials (n=37,000), 2 of high quality No “non monitoring” studies Most are dated Continuous EFM compared to intermittent auscultation Alfirevic et al. Cochrane 2006 (3) #CD N (trials)RR95% CI Perinatal Death33,513 (11) Neonatal Seizures32,386 (9) Cerebral Palsy13,252 (2) Cesarean Delivery18,761 (10) Operative VD18,151 (9)

7 No reduction in cerebral palsy Dramatic increase in cesarean delivery US Preventive Task Force Grade: D No evidence of benefit Evidence of harm 66% 85% Cesarean delivery rate % Intrapartum Monitoring % of US women with cEFM in labor Continuous Intrapartum Fetal Heart Rate Monitoring

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9 Why EFM does not seem to be efficacious: 1.Use of an outcome measure that is not related to variant FHR patterns 2.Lack of standardized interpretation 3.Disagreement regarding algorithms for intervention 4.Inability to demonstrate reliability, validity, and ability of FHR monitoring to allow timely intervention

10 Intrapartum FHR monitoring is not a failed technology It is a success on at least three fronts: Its introduction coincided with the virtual elimination of intrapartum fetal death It is at least as effective as intensive intermittent auscultation, the only alternative that has been studied in prospective trials While not a reliable DIAGNOSTIC test, it is an exceptional SCREENING test The other side…

11 Sponsored by:NICHD ACOG SMFM Additional groups represented: ACNMAWHONN AAPRCOG SOGCNational Cardiovascular Center - Japan

12 ‘The RCOG System – 2001’ ‘The use and interpretation of cardiotocography in intrapartum fetal surveillance’ RCOG Evidence-based Clinical Guideline No 8 Adopted by National Institute of Clinical Excellence (NICE) Published for May 2001 For this Workshop focus on terminology used in EFM Courtesy of Dr. David James

13 Four arguments for development of EFM Guidelines: 1. Intrapartum hypoxia 1% of all labors 10% perinatal deaths (Confidential Enquiry into Stillbirths and Deaths in Infancy [CESDI]) Intrapartum hypoxic death rate: 0.8 in1000 births 10% CP cases Intrapartum hypoxic CP rate: 0.1 in 1000 births Courtesy of Dr. David James

14 2. EFM use 239/248 (96.4%) maternity units in UK use EFM 26% did not have an EFM Guideline (30% in units > 3000 deliveries) Fetal blood sampling used in 88% Courtesy of Dr. David James Four arguments for development of EFM Guidelines:

15 3. Suboptimal EFM use CESDI reported that 70% of intrapartum deaths have suboptimal care Majority of examples relate to EFM Failure to recognize Failure to act Communication failure Courtesy of Dr. David James Four arguments for development of EFM Guidelines:

16 4. Medicolegal issues > $800 million estimate of NHS medicolegal costs currently > 60% are obstetric cases Majority of obstetric cases relate to fetal monitoring in labor Courtesy of Dr. David James Four arguments for development of EFM Guidelines:

17 Courtesy of Dr. David James

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19 RCOG Management Recommendations In cases where the CTG falls into the suspicious category, conservative measures should be used In cases where the CTG falls into the pathological category, conservative measures should be used Fetal blood sampling should be used where appropriate and feasible In situations where fetal blood sampling is not possible or appropriate, delivery should be expedited

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21 Risk of acidemia, evolution of FHR patterns to more serious risk, and recommended action VariableRisk of acidemiaRisk of evolutionAction Green0Very lowNone Blue0Low Conservative techniques & begin preparation Yellow0Moderate Conservative techniques & increased surveillance OrangeBorderline/acceptably lowHigh Conservative techniques & prepare for urgent delivery RedUnacceptably highNot a considerationDeliver Am J Obstet Gynecol 2007; 26.e3

22 Risk categories for fetal acidemia related to FHR variability, baseline rate and presence of recurrent decelerations. MODERATE (NORMAL) VARIABILITY NoEarlyMild VDMod VDSev VDMild LDMod LDSev LDMild PDMod PDSev PD TachyBBBYOYYOYYO NormalGGGBYBYYYYO Mild BrdYYYYOYYOYYO Mod BrdYYOOOO Sev BrdOOOOO MINIMAL VARIABILITY NoEarlyMild VDMod VDSev VDMild LDMod LDSev LDMild PDMod PDSev PD TachyBYYOOOOROOO NormalBBYOOOOROOR Mild BrdOORRRRRRRRR Mod BrdOORRRR Sev BrdRRRRR ABSENT VARIABILITY NoEarlyMild VDMod VDSev VDMild LDMod LDSev LDMild PDMod PDSev PD TachyRRRRRRRRRRR NormalORRRRRRRRRR Mild BrdRRRRRRRRRRR Mod BrdRRRRRR Sev BrdRRRRR SinusoidalR Marked VariabilityY VD, Variable decelerations; LD, Late decelerations; PD, Prolonged decelerations; Brd, Bradycardia; Tachy, Tachycardia G, Green; B, Blue; Y, Yellow; O, Orange

23 The “Miller Method” of EFM Interpretation

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25 Normal tracing Previously “Reassuring” Atypical Tracing Previously “Non-reassuring” Abnormal Tracing Previously “Non-reassuring” BASELINE  bpm  Bradycardia bpm  Tachycardia > 160 for min  Rising baseline  Bradycardia < 100 bpm  Tachycardia > 160 for < 80 min.  Erratic baseline VARIABILITY  6-25 bpm  ≤ 5 bpm for < 40 min.  ≤ 5 bpm for min.  ≤ 5 bpm for > 80 min.  ≥ 25 bpm for > 10 min.  Sinusoidal DECELERATIONS  None  Occasional uncomplicated variables  Occasional early decelerations  Repetitive (≥ 3) uncomplicated variable decelerations  Occasional late decelerations  Single prolonged deceleration lasting > 2 min. but < 3 min.  Repetitive (≥ 3) complicated variables ACCELERATIONS  Spontaneous accelerations present  Accelerations present with fetal scalp stimulation  Absence of acceleration with fetal scalp stimulation  Usually absent ACTION EFM may be interrupted for periods up to 30 min if maternal- fetal condition stable and/or oxytocin infusion rate stable Further vigilant assessment required, especially when combined features present. ACTION REQUIRED: Review overall clinical situation, obtain scalp pH if appropriate; prepare for delivery SOGC EFM Classification System:

26 SOGC Normal Tracing Baseline: bpm Variability: 6-25 bpm or < 5 bpm or < 40 min Decelerations: Frequency: None or occasional Type: Uncomplicated variables or early Accelerations: Spontaneous accelerations present OR accelerations with scalp stimulation > 15 bpm for > 15 sec at > 32 weeks > 10 bpm for > 10 sec at < 32 weeks Action: EFM may be interrupted for periods < 30 min IF maternal condition and oxytocin infusion rate is stable

27 SOGC Atypical Tracing Baseline: bpm or > 160 bpm for >30 and < 80 min OR rising baseline Variability: < 5 bpm for min Decelerations: Repetitive (>3) uncomplicated variables Occasional late decelerations Single prolonged deceleration > 2 min but < 3 min Accelerations absent with scalp stimulation Action: Further vigilant assessment required, especially if multiple features present

28 SOGC Abnormal Tracing Baseline: Bradycardia ( 160 for < 80 min), OR erratic baseline Variability: 80 min, > 25 bpm for > 10 min, OR sinusoidal Decelerations: Repetitive (>3) COMPLICATED variables Deceleration to 60 sec or single prolonged deceleration > 3 min but < 10 min Loss of variability in trough Overshoots Slow return to baseline Late decelerations > 50% of contractions Accelerations usually absent Action: Review clinical situtation, obtain scalp pH if appropriate, and prepare for delivery

29 Summary of EFM Interpretation Systems 1997 NICHD: 2 tier RCOG: 3 tier Extensive vetting and peer review National implementation, 50% drop in intrapartum death rate SOGC: 3 tier Extensive vetting and peer review Parer: 5 tier Applied knowledge, interdisciplinary Variability driven Miller: 3 tier Least stringent Common sense approach Definition, interpretation, management

30 NICHD Workshop: Objectives Update definitions System needs to be SIMPLE and evidence based Need consistency of FHR description across the country Develop research agenda

31 NICHD: Assumptions The definitions were developed for visual interpretation of FHR patterns FHR pattern features: baseline, episodic and periodic No distinction is made between short term and long term variability FHR tracings should be evaluated in context of clinical conditions (GA, medications, maternal medical conditions, fetal conditions)

32 An EFM requires QUALITATIVE and QUANTITATIVE description of all of the following components: Uterine contractions Baseline FH rate Baseline FHR variability Presence of accelerations Periodic or episodic decelerations Changes or trends of FHR patterns over time NICHD: Description of FHT Components

33 Number of uterine contractions per 10 minute window Averaged over 30 min Normal: ≤ 5 contractions in 10 min Tachysystole: > 5 contractions in 10 min Presence or absence of decelerations Spontaneous and stimulated labor The terms “hyperstimulation” and “hypercontractility” are to be abandoned NICHD: Description of Contractions

34 NICHD: Describing FHR Baseline Rounded to 5 bpm Assembled from segments of baseline totaling at least 2 min with in a 10 min window Excludes periods of accelerations, decelerations and hypervariability Bradycardia is < 110 bpm Tachycardia is > 160 bpm

35 FHR Baseline

36 NICHD: Describing FHR Variability

37 FHR Variability Excludes accelerations, decelerations Quantitated as peak-to-trough Absent variability: amplitude undetectable Minimal variability: amplitude detectable but ≤ 5 bpm Moderate variability: amplitude 6-25 bpm Marked variability: amplitude > 25 bpm

38 Absent Variability Minimal Variability Marked Variability Moderate Variability

39 NICHD: Describing Accelerations Abrupt increase in FHR Onset to peak < 30 seconds Peak: ≥ 15 bpm lasting 15 seconds from onset to return to baseline Prolonged acceleration: ≥ 2 min but < 10 min Acceleration > 10 min = baseline change

40 NICHD: Describing Decelerations Decrease in FHR associated with uterine contraction Gradual decrease: onset to nadir ≥ 30 sec Abrupt decrease: onset to nadir < 30 sec Recurrent decelerations: Occur with ≥ 50% of contractions Intermittent decelerations: Occur with < 50% of contractions

41 NICHD: Classifying Decelerations OnsetShapeNadir EarlyGradualSymmetricalMatches UC peak VariableAbruptAsymmetrical ≥ 15 bpm lasting ≥ 15 sec but < 2 min LateGradualSymmetricalAfter UC peak

42 NICHD: Deceleration Features NOT Defined Slow return to baseline Biphasic decelerations ‘Reflex’ tachycardia following variable decelerations (“shoulders” or “overshoots”) FHR fluctuations in the trough of the deceleration Mild, moderate and severe

43 NICHD: What to Call the Categories? Three-tier classification system: Systems agree on the really good and really bad Middle group requires ongoing surveillance “Good”: Normal? Reassuring? Non-pathological? Middle: Intermediate? Indeterminate? Undetermined significance? “Bad”: Abnormal? Non-reassuring? Pathological?

44 After Extensive Discussion… Initial conference decision: Normal: “reassuring” Equivocal: requires ongoing assessment / evaluation Abnormal: requires urgent action Concerns about implied action necessary (e.g. equivocal requires intervention) Final classification system: Category I Category II Category III

45 NICHD 3 Tier Interpretation System: Category I Category I FHR tracings must exhibit ALL of the following features: Baseline rate: bpm Baseline FHR variability: moderate Late or variable decelerations: absent Early decelerations: present or absent Accelerations: present or absent

46 Category III FHR tracings include EITHER: Absent FHR variability with any ONE of the following: Recurrent late decelerations Recurrent variable decelerations Bradycardia Sinusoidal Pattern for ≥ 20 min NICHD 3 Tier Interpretation System: Category III

47 NICHD: Category III

48 Category II includes all FHR tracings not categorized as Category I or Category III Represent an appreciable majority of those encountered in clinical care Moderate variability with bradycardia Minimal FHR variability Absent variability with no recurrent decels Recurrent variables with moderate variability Recurrent late decelerations with moderate variability NICHD 3 Tier Interpretation System: Category II

49 NICHD: Category II

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51 NICHD FHR Categories: Meaning and Action Category I = “n ormal” Strongly predictive of normal acid base status Follow in a ‘routine manner’ Category III = “abnormal” Predictive of abnormal acid base status Prompt evaluation required Resolve the pattern (corrective measures, delivery)

52 Category II: “indeterminate” Not predictive of abnormal acid base status Inadequate evidence to classify either as Category I or as Category III Requires continued re-evaluation and surveillance, consideration of additional testing and non-surgical interventions NICHD FHR Categories: Meaning and Action

53 NICHD: Interventions for Category II and III Tracings Acceleration testing: Fetal scalp sampling Scalp stimulation (digital or Allis clamp) Vibroacoustic stimulation Stop oxytocin Cervical exam: Cord prolapse? Rapid dilation? Descent of head? ACOG Practice Bulletin 2009

54 Change maternal position Assess and treat hypotension Assess for uterine tachysystole Maternal oxygen Tocolytic therapy Consider amnioinfusion for recurrent variable decelerations ACOG Practice Bulletin 2009 NICHD: Interventions for Category II and III Tracings (cont.)

55 Abnormal despite interventions  deliver NICHD: Persistent Category III

56 Implementation of 3-tier system: Recommend starting now Description of contractions Be more descriptive with Category II tracings (include baseline, variability, accelerations, decelerations, trends over time, and contractions) Education Multidisciplinary

57 Research Directions Observational studies of Category II tracings Correlate to acid base status, and to perinatal and pediatric outcomes Computerized EFM assessment Analysis of FOX tracings Education / dissemination

58 New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them Mary E. D’Alton, MD Willard C. Rappleye Professor Chair, Department of Obstetrics and Gynecology Columbia University College of Physicians and Surgeons New York, New York All the possibilities of modern medicine

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