New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them Mary E. D’Alton, MD Willard C....
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Transcript of New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them Mary E. D’Alton, MD Willard C....
New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them
Mary E. D’Alton, MDWillard 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
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
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 CommissionSentinel Event Alert: Issue 30 –July 21, 2004
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; 177:1385-90).
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) #CD006066
N (trials) RR 95% CIPerinatal Death 33,513 (11) 0.85 0.59-1.23Neonatal Seizures 32,386 (9) 0.50 0.31-0.80Cerebral Palsy 13,252 (2) 1.74 0.97-3.11Cesarean Delivery 18,761 (10) 1.66 1.30-2.13Operative VD 18,151 (9) 1.16 1.01-1.32
No reduction in cerebral palsyDramatic increase in cesarean delivery
0
5
10
15
20
25
30
35
1970 1975 1980 1985 1990 1995 2000 2005
Cesarean
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
Why EFM does not seem to be efficacious:1. Use of an outcome measure that is not related to
variant FHR patterns2. Lack of standardized interpretation3. Disagreement regarding algorithms for intervention4. Inability to demonstrate reliability, validity, and ability
of FHR monitoring to allow timely intervention
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…
Sponsored by: NICHD
ACOG
SMFM Additional groups represented:
ACNM AWHONN
AAP RCOG
SOGC National Cardiovascular
Center - Japan
‘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
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
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:
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:
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:
Courtesy of Dr. David James
Courtesy of Dr. David James
Courtesy of Dr. David James
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
Risk of acidemia, evolution of FHR patterns to more serious risk, and recommended action
Variable Risk of acidemiaRisk of evolution
Action
Green 0 Very low None
Blue 0 LowConservative techniques &
begin preparation
Yellow 0 ModerateConservative techniques &
increased surveillance
OrangeBorderline/acceptably low
HighConservative techniques & prepare for urgent delivery
Red Unacceptably highNot a consideration
Deliver
Am J Obstet Gynecol 2007; 26.e3
Risk categories for fetal acidemia related to FHR variability, baseline rate and presence of recurrent decelerations.MODERATE (NORMAL) VARIABILITY
No Early Mild VD Mod VD Sev VD Mild LD Mod LD Sev LD Mild PD Mod PD Sev PD
Tachy B B B Y O Y Y O Y Y O
Normal G G G B Y B Y Y Y Y O
Mild Brd Y Y Y Y O Y Y O Y Y O
Mod Brd Y Y O O O O
Sev Brd O O O O O
MINIMAL VARIABILITY
No Early Mild VD Mod VD Sev VD Mild LD Mod LD Sev LD Mild PD Mod PD Sev PD
Tachy B Y Y O O O O R O O O
Normal B B Y O O O O R O O R
Mild Brd O O R R R R R R R R R
Mod Brd O O R R R R
Sev Brd R R R R R
ABSENT VARIABILITY
No Early Mild VD Mod VD Sev VD Mild LD Mod LD Sev LD Mild PD Mod PD Sev PD
Tachy R R R R R R R R R R R
Normal O R R R R R R R R R R
Mild Brd R R R R R R R R R R R
Mod Brd R R R R R R
Sev Brd R R R R R
Sinusoidal R
Marked Variability Y
VD, Variable decelerations; LD, Late decelerations; PD, Prolonged decelerations; Brd, Bradycardia; Tachy, Tachycardia
G, Green; B, Blue; Y, Yellow; O, Orange
The “Miller Method” of EFM Interpretation
www.SOGC.org
Normal tracingPreviously “Reassuring”
Atypical TracingPreviously “Non-reassuring”
Abnormal TracingPreviously “Non-reassuring”
BASELINE 110-160 bpm Bradycardia 100-110 bpm Tachycardia > 160 for 30-80 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 40-80 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:
SOGC Normal Tracing
Baseline: 110-160 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
SOGC Atypical Tracing
Baseline: 100-110 bpm or > 160 bpm for >30
and < 80 min OR rising baseline Variability: < 5 bpm for 40-80 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
SOGC Abnormal Tracing
Baseline: Bradycardia (< 100 bpm), tachycardia (> 160
for < 80 min), OR erratic baseline Variability: < 5 bpm for > 80 min, > 25 bpm for > 10
min, OR sinusoidal
Decelerations: Repetitive (>3) COMPLICATED variables Deceleration to < 70 bpm for > 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
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
NICHD Workshop: Objectives
Update definitions System needs to be SIMPLE and evidence
based Need consistency of FHR description across
the country Develop research agenda
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)
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
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
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
FHR Baseline
NICHD: Describing FHR Variability
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
Absent Variability Minimal Variability
Marked VariabilityModerate Variability
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
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
NICHD: Classifying Decelerations
Onset Shape Nadir
Early Gradual Symmetrical Matches UC peak
Variable Abrupt Asymmetrical
≥ 15 bpm lasting ≥ 15 sec but < 2 min
Late Gradual Symmetrical After UC peak
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
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?
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
NICHD 3 Tier Interpretation System:Category I
Category I FHR tracings must exhibit ALL of the following features: Baseline rate:110-160 bpm Baseline FHR variability: moderate Late or variable decelerations: absent Early decelerations: present or absent Accelerations: present or absent
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
NICHD: Category III
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
NICHD: Category II
NICHD: Category II
NICHD FHR Categories: Meaning and Action
Category I = “normal” 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)
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
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
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.)
Abnormal despite interventions deliver
NICHD: Persistent Category III
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
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
New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them
Mary E. D’Alton, MDWillard 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