1. Medico-Legal Issues related to Intrapartum CTG
S.Arulkumaran
Professor & Head
Obstetrics & Gynaecology
St.George’s Hospital Medical School University of London

2. Should we use EFM? CTG is the key in most obstetric litigation
RCT’s – No reduction in PN deaths or CP*
- Increase in CS rate
- Reduction in NN convulsions (?HIE)
*Inadequate numbers to show these end points
CESDI – IP deaths due to hypoxia
- Inability to interpret, failure to incorporate clinical picture, inappropriate action, delay in intervention

4. Litigation Liability & Causation
Abnormal CTG, low Apgar score, low cord arterial pH, assisted ventilation, admission to SCBU, HIE > Neurological damage
Several intrinsic fetal disorders cause neurological disability – abnormal CTG & inappropriate management may be coincidental.
Mismanagement of labour may not be relevant to the outcome

5. Acute IP events & cerebral palsy
ESSENTIAL CRITERIA;
Evidence of metabolic acidosis in cord UA or early NN samples; pH<7.0 & BD >12 mmol/l
Early onset of severe or moderate neonatal encephalopathy in infants >34wk
Cerebral palsy of a spastic quadriplegic or dyskinetic type

6. Acute IP events & Cerebral palsy
ADDITIONAL CRITERIA
A sentinel hypoxic event occurring immediately before or during labour
A sudden rapid sustained deterioration in FHR pattern
Apgar scores of <7 for more than 5 mins
Early evidence of multisystem involvement
Early imaging evidence of acute cerebral involvement

7. Liability
Abnormal CTG & poor outcome – causation is not in doubt > ?Liability
? Appropriate action taken in the presence of abnormal CTG
Expert opinion – Care given fell short of what was expected by a responsible body of medical opinion (BOLAM PRINCIPLE)

8. Bolam Principle – ‘The test is the standard of the ordinary skilled man exercising and professing to have the specialist skill. A man need not possess the highest expert skill at risk of being found negligent ….’
BOLITHO PRINCIPLE – ‘It can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible.’

9. Timing & Severity of Injury
Timing of injury is not always possible based on the CTG
Grossly abnormal CTG may suggest possible injury but cannot predict the severity of the injury
In the presence of abnormal CTG how long can one wait before intervention? Does the delay worsen the injury without changes in the CTG?

10. Review of cases with CP or IP - SB
Acute hypoxia – Prolonged bradycardia
Sub-acute hypoxia – Prolonged decelerations
The above two patterns usually present with acute clinical events or in late first or second stage of labour/ at times cause unknown
Gradually developing hypoxia
Long standing hypoxia – reduced variability +/- shallow decelerations

11. ACUTE HYPOXIA PRESENTS WITH PROLONGED BRADYCARDIA
ABRUPTION, CORD PROLAPSE, SCAR RUPTURE
UTERINE HYPERSTIMULATION / TOCOLYSIS
Important considerations - CTG PRIOR TO BRADYCARDIA & CLINICAL PICTURE- TMS, IUGR, infection, APH etc

16. Long standing hypoxic pattern
No accelerations
Markedly reduced baseline variability
Shallow decelerations <15 beats
May have a normal baseline rate

23. Subacute hyoxia
Prolonged decelerations – More time below the baseline rate (e.g.>90 secs) and shorter duration at the baseline rate (<30 secs)
Less than optimal circulation through the placenta

30. GRADUALLY DEVELOPING HYPOXIA
Accelerations do not appear
BASELINE RATE increases and VARIABILITY reduces
CONSIDER THE CLINICAL PICTURE (parity, cervical dilatation, rate of progress, high risk factors)
IF REQUIRED PERFORM FBS X 2

31. Xxx
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40. Fetal behavioural state - Cycling
Cycling with a reactive followed by a sleep pattern suggests that the baby is neurologically normal
Absence of cycling may be due to drugs, infection, cerebral haemorrhage, chromosomal or congenital malformation, previous brain damage
Previously brain damaged baby may or may not show cycling but cord pH may be normal; such babies may not show evidence of HIE but may exhibit signs of neurological damage that manifests later

42. Perfusion injury ? Timing of injury ?
This tracing continues with the one following. It reveals a perfectly normal heart rate pattern with accelerations, a stable baseline rate, normal variability and absent decelerations. In the lower panel there is an obvious deceleration lasting about 3 minutes. The most reasonable interpretation of the decelerations is that of an acute ischemic event (e.g. cord complication). Notice that the deceleration initially recovers to a higher rate then seems to be returning to its previous rate. See next page

43. HOW TO REDUCE HYPOXIC EVENTS/ LITIGATION – Education & Risk management
Regular knowledge update at CTG courses
Review of CTG’s with poor outcome – in hospital training – two weekly?
Availability of learning materials- books/CD’s
Incidence reporting and risk management

44. How to reduce hypoxic events/ LITIGATION – Good clinical practice & Good communication
Establish and encourage accepted lines of command & communication
Appropriate action. e.g. change of position, hydration, stop oxytocin infusion, intrauterine resuscitation with tocolytics, FBS, amnio-infusion, Oxygen to mother ?
Consider obtaining additional information; pH, pulse oximetry, STAN, Computer analysis/ neural network
Good communication

45. Evidence to help defend a case - Cord pH & good records
Selective or routine cord blood sampling – two vessels/ arterial?
Potential for poor outcome – two vessels. E.g. Operative delivery for fetal distress, low Apgar scores, TMS, pre-term, abnormal CTG/FBS, cases of infection, IUGR, APH.
Consider online electronic archival of CTG and notes (WORM disks)

46. Obstetric accidents: a review of 64 cases. Ennis & Vincent
Obstetric accidents: a review of 64 cases. Ennis & Vincent .BMJ 1990;300:1365-7
11 cases – CTG was omitted
19 cases – CTG was missing
6 cases - CTG was unreadable
14 of the remaining 28 cases signs of fetal distress went unnoticed or were ignored

47. Overview of functions Can integrate with3rd-party
Possible to export data
Can integrate with3rd-party
Software
Statistics
Generate Forms
Flow sheets
Surveillance
and Alerting
Agilent OB TraceVue is a patient-oriented, departmental information management solution for obstetrical care. This next-generation product combines surveillance and alerting with comprehensive patient documentation and data storage in one system.
The entire continuum of OB care, from initial antepartum visits through delivery and discharge, as well as across the patient’s previous pregnancies, can all be recorded, reviewed, and retained. Agilent OB TraceVue truly offers you the highest quality flexible data management capabilities.
Among its highlights:
Patient data access from any point of care, the central station, bedsides, lounges and offices
Basic and Advanced Alerting informs you immediately of critical events
Forms-based and flow sheet-based patient charting, together with annotated tracings, provides complete electronic patient records and ensures fast and easy information access
Support of statistical evaluation and reporting for administration, research, and quality purposes
Long-term storage on optical media
Use of 3rd-party software on the OB TraceVue PCs
Bi-directional ADT Interface to Hospital Information System, HL-7- based
Support of up to 50 PC clients and connected fetal monitors per system to meet the needs of large institutions
ADT Interface
to HIS
Data Storage CTG (8 hrs) + notes of 4000 women in one WORM disk (25y)

48. Record Keeping
When CTG is not up to the time of delivery or the CTG is not technically satisfactory – auscultate & record
In cases with abnormal CTG and poor outcome – describe the CTG in the notes
??Photocopy the CTG & notes – certify – separate copy with risk manager – Confidentiality issues??
Avoids fading of the CTG, missing pages or notes & introduction of additional notes

53. THANKYOU