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

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

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

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

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

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)

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.’

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?

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

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

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

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

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

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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

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

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

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

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)

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

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)

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

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