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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*
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Medico-Legal Issues related toIntrapartum 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
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 .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 Possible to export data Can integrate with3rd-party Software Statistics Generate Forms Flow sheets Surveillance and Alerting 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