1. New Guidelines for Fetal Heart Rate Monitoring: How to Adopt Them
All the possibilities of modern medicine
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

2. Background
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
The format of state-of the-science conferences held by the NIH are similar to but different from the consensus development program conferences. The goal is not to develop a consensus but to assess a topic that is of public health importance and for which controversy or unresolved issues can be clarified.

3. Joint Commission Sentinel Event Alert: Issue 30 –July 21, 2004
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…
The NIH has a history of involvement and interest in cesareans.
In 1980, they sponsored a consensus conference on cesarean births.
At the time, the national cesarean rate was 15-20% and the main focus and attention was paid to primary cesareans.
in the summary statement regarding repeat Cesareans and VBAC trials, they stated that “…”

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: ).

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
N (trials) RR
95% CI
Perinatal Death
33,513 (11)
0.85
Neonatal Seizures
32,386 (9)
0.50
Cerebral Palsy
13,252 (2)
1.74
Cesarean Delivery
18,761 (10)
1.66
Operative VD
18,151 (9)
1.16
Alfirevic et al. Cochrane 2006 (3) #CD006066

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

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

10. The other side… 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

11. Sponsored by: NICHD
ACOG
SMFM
Additional groups represented:
ACNM AWHONN
AAP RCOG
SOGC National 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:
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 births
Courtesy of Dr. David James

14. Four arguments for development of EFM Guidelines:
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

15. Four arguments for development of EFM Guidelines:
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

16. Four arguments for development of EFM Guidelines:
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

17. Courtesy of Dr. David James

18. Courtesy of Dr. David James

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
Courtesy of Dr. David James

21. Risk of acidemia, evolution of FHR patterns
to more serious risk, and recommended action
Variable
Risk of acidemia
Risk of evolution
Action
Green
Very low
None
Blue
Low
Conservative techniques & begin preparation
Yellow
Moderate
Conservative techniques & increased surveillance
Orange
Borderline/acceptably low
High
Conservative techniques & prepare for urgent delivery
Red
Unacceptably high
Not a consideration
Deliver
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 No
Early
Mild VD
Mod VD
Sev VD
Mild LD
Mod LD
Sev LD
Mild PD
Mod PD
Sev PD
Tachy B Y O
Normal G
Mild Brd
Mod Brd
Sev Brd
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 O R
Normal
Mild Brd
Mod Brd
Sev Brd
ABSENT VARIABILITY No
Early
Mild VD
Mod VD
Sev VD
Mild LD
Mod LD
Sev LD
Mild PD
Mod PD
Sev PD
Tachy R
Normal O
Mild Brd
Mod Brd
Sev Brd
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

23. The “Miller Method” of EFM Interpretation

25. Previously “Reassuring” Previously “Non-reassuring”
SOGC EFM Classification System:
Normal tracing
Previously “Reassuring”
Atypical Tracing
Previously “Non-reassuring”
Abnormal Tracing
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

26. SOGC Normal Tracing Baseline: 110-160 bpm
Variability: 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: 100-110 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 (< 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

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
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. NICHD: Description of FHT Components
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
AnEFM tracing requires qualitative and quantitative description

33. NICHD: Description of Contractions
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

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
Moderate Variability
Marked 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
Onset
Shape
Nadir
Early
Gradual
Symmetrical
Matches UC peak
Variable
Abrupt
Asymmetrical
≥ 15 bpm lasting
≥ 15 sec but < 2 min
Late
After 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. NICHD 3 Tier Interpretation System: Category III
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

47. NICHD: Category III

48. NICHD 3 Tier Interpretation System: Category II
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

49. NICHD: Category II

50. NICHD: Category II

51. 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)

52. NICHD FHR Categories: Meaning and Action
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

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. NICHD: Interventions for Category II and III Tracings (cont.)
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

55. NICHD: Persistent Category III
Abnormal despite interventions  deliver

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
All the possibilities of modern medicine
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