medico-legal perspectives on the reintroduction of vaginal breech births

Medico-Legal Issues and

Breech Birth

School of Women’s & Children’s Health

Professor Alec WelshMBBS MSc PhD FRCOG(MFM) FRANZCOG DDU CMFM

Professor in Maternal-Fetal Medicine

School of Women‟s & Children‟s Health

University of New South Wales

Randwick, Sydney

Head of Department

Maternal-Fetal Medicine

Royal Hospital for Women

Randwick, Sydney

Director

Australian Centre for Perinatal Science

University of New South Wales

Randwick, Sydney

The Term Breech

Trial

[email protected] Issues and the current state of vaginal breech birth:

4th Annual Obstetric Malpractice Conference (21-22 June 2012)

Why the TBT was needed

Until the late 1950s Vaginal Birth (VB) was mode of

choice

Wright 1959; Trolle D 1960: 3-4x increase in perinatal

mortality cf CS

Balanced by CS risks

By 1980s CS rate about 80%

No conclusive evidence: 2 RCTs in early 80‟s

Increased fetal risk with VD

Small numbers and still maternal risk

Small retrospective studies contradictory



Why the TBT was needed

1979 Archie Cochrane awarded obstetrics the

„wooden spoon‟ for least evidence based

medical specialty

RCT became the answer to medical questions,

no matter how complex

Medicolegal anxiety esp in USA provoked a

justification for CS, reducing medicolegal risk



The TBT

Lancet 2000 Oct 21

Hannah et al



Construction of the TBT

Singleton live fetus in a frank or complete breech at

term (≥37 weeks)

Exclusion if >4kg; hyperextension; fetal anomaly;

contraindication such as placenta praevia

2083 women across 121 centres in 26 countries with

varied perinatal mortality rates

Vaginal breech birth performed by „experienced

clinicians‟ as judged by self and supervisor



Construction of the TBT

Primary outcomes: perinatal mortality; neonatal mortality; or one of a number of measures of serious morbidity

Secondary outcomes: Maternal mortality or serious morbidity during first 6 weeks postpartum

Sample size calculated as 2800 with an 80% power to find a reduction in risk of perinatal or neonatal mortality or serious morbidity from 0.8% with VB to 0.1% with CS

Second interim analysis at 1600 recommended ceasing; another 488 meanwhile recruited => 2088



Results of the TBT

2088 women: entry and outcome data for

99.8% women

Planned CS – 90.4% delivered by CS

Planned VB – 56.7% delivered vaginally

6 of 16 deaths associated with difficult vaginal

delivery

4 deaths associated with FHR abnormalities in

labour



Results of the TBT

Perinatal mortality, neonatal mortality or serious

neonatal morbidity significantly lower for

planned CS vs VB (1.6% vs 5.0%)

Relative Risk 0.33 (95% CI 0.19-0.560 p<0.0001.

No differences for maternal mortality or serious

maternal morbidity (3.9% vs 3.2%).

RR 1.24 (0.79-1.95) p=0.35.



Results of the TBT

After removing confounders still lower risk of

complications with CS

Policy of planned CS meant for every additional

14 CS performed one baby will avoid death or

serious morbidity



The Impact of the

TBT



Unprecedented impact

Professional obstetrical associations worldwide

released guidelines and opinion statements

recommending a policy of routine CS for breech

(e.g. ACOG/RCOG)

Denmark: CS increased from 79.6% to 94.2%

Netherlands: over 2 months CS rate increased from

50% to 80%

Canadian survey: VB offer dropped from 84% to 14%

By 2003 >92.5% of TBT centres had completely

abandoned VB



Rietberg et al. BJOG 2005



The Australian Context

Muted acceptance of the TBT conclusions: planned for

discussion at a breakfast meeting at PSANZ – no discussion

The „Medical Indemnity Crisis‟ of 2000-201:

NSW Supreme Court: Simpson $11M payout for obstetric

negligence (cerebral palsy following failed forceps and CS)

Collapse of UMP: providing indemnity for 90% NSW doctors

Indemnity Summit – Policy Support Scheme – if >7.5% of gross

income.....

MacLennan & Spencer MJA 2002: Projections of Australian

obstetricians ceasing practice and the reasons

Obstetric trainee recruitment decline from 2000-2010



Impact within Australia

Between 1991 and 2005 VB of singleton breech fetuses

in Australia dropped from 23.1% to 3.7%.

NSW, 66% decline in VB for breech with steepest

decline 2000-2001: corresponded to a halving of the

breech PNMR 6.2 to 3.1/1000.

Feb 2001: RANZCOG statement

that VB of the breech fetus carries

higher risk than PCS.

Phipps et al. JANZCOG 2003



Workforce issues of the TBT

Dramatic reduction in training for junior

obstetricians in vaginal breech birth

Significant issues in 2 situations:

Client refusal to consent for caesarean section

Arrival to hospital too late for safe CS (breech „on-view‟)

Lost skills results in unnecessary fetal and

maternal mortality and morbidity



2 year follow up

papers from the

TBT



Maternal and child outcomes at 2 years:

AmJOG 2004



Outcomes of children at 2 years

923 of 1159 children (79.6%) from 85 centres followed to 2

years

Risk of death or neurodevelopmental delay no different for

CS than VB (14(3.1%) vs 13(2.8%); RR1.09 (CI 0.52-2.30)

6% absolute increase in risk of unspecified medical

problems in children randomised to PCS

Conclusion: Planned caesarean section delivery is not

associated with a reduction in risk of death or

neurodevelopmental delay in children at 2 years of age



Outcomes of mothers at 2 years

917 of 1159 (79.1%) from 85 centres completed a structured

maternal questionnaire

No differences: breast feeding; relationships; pain;

pregnancy; incontinence; depression; etc

Planned CS associated with a higher risk of constipation

Conclusion: Maternal outcomes at 2 years postpartum

are similar after planned caesarean section and vaginal

birth for the singleton breech fetus at term



A call for retraction



Editorial: John M Grant BJOG

“The Term Breech Trial is an example of a randomised trial that was

impeccable as regards its methodological design, but was

questionable as regards it clinical design.

“More attention ... power calculation, randomization and interim

analysis, and less to clinical outcomes such as reasons for

perinatal death and definition of serious neonatal morbidity.

“As regards the infant, main concern of vaginal breech delivery is

trauma and birth asphyxia...; the main concern of elective

caesarean section is respiratory distress. These should have been

the primary outcomes of the trial”



Editorial: John M Grant BJOG

“Almost immediately, the conclusions of the trial were

accepted by the medical community.

“Rarely in medical history have the results of a single

research project so profoundly and so ubiquitously changed

medical practice as in this publication.

“A recent survey (>80 centres in 23 countries) concluded that

92.5% of the surveyed centres have completely abandoned

planned vaginal breech delivery in favour of caesarean

delivery.”



What was wrong

with the TBT?



TBT: A perfect statistical study

(in an imperfect clinical world)

Multicentre

Randomised

Controlled

Trial

Intention to Treat

Compound

morbidity

Multioperator in a diverse

range of environments

Reducing a complex clinical

issue to a simple

randomisation process

Statistically „ideal‟ but relates

poorly to actual management

Inability for any single

morbidity to be significant plus

varied relevance and [email protected]

Medico-Legal Issues and the current state of vaginal breech birth: 4th Annual Obstetric Malpractice Conference (21-22 June 2012)

The Flaws in TBT: The Deaths

3 deaths in CS group

1. 2300g respiratory issues post CS

2. 2850g myelomeningocoele ruptured during CS

3. 2550g stillborn after attempted difficult vaginal birth

13 deaths in planned VB

1. Twin BW 1150g

2. 3650g CEPHALIC

3. 2000g Late neonatal death: sent home well

4. 2500g discharged home well died after d&v

5. 2500 and 2700g neonatal deaths: respiratory no issues with

birth

6. 3 x FHR abnormalities: 2 loss of FH before CS

7. 3370g difficult delivery led to CS

Only 4 deaths

where difficult

vaginal birth



The Flaws in TBT: Serious Neonatal Morbidity

Issues of „Compound Morbidity‟:

14 in CS, 39 in VB

Hypotonia: 2 CS vs 18 VB. In 7 of 18 disappeared at 2 hours

Abnormal level of consciousness in 13 of planned VB

Of the 69 cases of composite perinatal morbidity and death

on which all of the conclusions are based, only 16 cases

could be related to the mode of delivery. Not statistically

significant



The Flaws in TBT: other issues

There is an argument against indiscriminate allocation to VB

or CS: case selection

During active labour only borderline difference in perinatal

outcome in favour of PCS (OR 0.57; 0.32-1.02: p=0.06)

Study included 2 sets of twins, 1 anencephaly and 2 stillbirths

Fetuses >4000g overrepresented in VB group (5.8% vs 3.1%)

Huge variation in standard of care between participating

centres

Many VB didn‟t get skilled accoucher: 18.5% obstetric

trainees; 2.9% student midwife: accounted for 32% of infants

with significant morbidity

More than half the data from countries with PNMR >20/1000



Glezerman: AmJOG Opinion 2006: 5 years to the term breech trial: The rise and fall of a

randomised controlled trial

“Repeated analysis of the data after 2 years, reveals that the initial

conclusions can no longer be maintained and that actually there

was no difference in outcome between the 2 groups. This was true

for both neonates and mothers. Yet, until now, the authors continue,

in all subsequent publications, to reiterate their original conclusions..

“A comprehensive and unequivocal withdrawal of the TBT

conclusions by the authors themselves is overdue.

“Most probably the point of no return has been reached as far as

planned vaginal breech delivery is concerned, despite the fact that

evidence is still lacking.”



Evidence since the

TBT papers



De Leeuw. The end of vaginal breech delivery.

BJOG 2007 (letter)

Impact of TBT in the Netherlands (2001-2005):

327 planned CS needed to save one extra child and even more child deaths due to cases of uterine rupture, praevia and increased SB rate before term with previous CS

4 maternal deaths as a result of elective CS for breech

Uterine scars and future accreta

Future pregnancies 4 children with brain damage from uterine rupture

35 million Euros spent on 7500 extra CS

Netherlands: 2154 children born after PVB: 98.1% alive and well cf 99.8% elCS and 99.3% emCS

Should 997 out of 1000 women have a superfluous CS to save the life of 3 babies?



Other issues

Issues with standard of care in the TBT means that

adverse outcomes are not surprising

Randomisation homogenises a heterogeneous

population with varying risk profiles.

Subsequent results not reflective or applicable to well

selected, low risk groups in experienced centres.

A number of obstetric units with tradition of vaginal

breech birth conducted retrospective audits and national

population studies.

Most of these found no significant difference in severe

morbidity and perinatal / neonatal mortality with a low

overall incidence of adverse outcome compared to the

TBT [email protected]

Medico-Legal Issues and the current state of vaginal breech birth: 4th Annual Obstetric Malpractice Conference (21-22 June 2012)

The Premoda Study.

Goffinet et al. AmJOG 2006

Observational: all term singleton breeches in France

and Belgium over one year

2529 PVB; 5576 PCS

TBT comparable composite variable

Low rate of overall adverse outcome (1.59% vs 3.22%

in TBT) with no sig difference between groups.

Why?

Unbroken tradition of VB in France & Belgium

Better selection of candidates

Higher standard of care

More stringent management guidelines



Where are we now

medicolegally?



College Statements

RANZCOG statement on vaginal breech 2009: now revised

to allow the existence of subgroups with the potential for

successful VB, advising management to be individualised

SOGC Guideline 2009: Careful case selection and labour

management in a modern obstetrical setting may achieve a

level of safety similar to elective Caesarean section. Planned

vaginal delivery is reasonable in selected women with a term

singleton breech fetus.



Current practice:‘Judgement by practice of peers’

Most obstetricians do not wish to provide

planned Vaginal Birth for Breech Presentation

2 major reasons:

Lack of current experience

Medico-legal fear



What is the current legal opinion?American Legal Firm Website June 2012:

“For breech births, a compressed cord means the infant

cannot get enough oxygen because the head remains in

the birth canal.

“If the doctor fails to identify a breech position before labor

occurs, many complications can occur.

“The baby must be delivered quickly to avoid brain damage

from a potentially compressed cord that may cut off the

child‟s supply of blood and oxygen.

“A vaginal breech delivery can be dangerously delayed if

the infants head catches inside the mother



Report of a maternal death in a breech birth:

Lawson. Birth 2011

Around the time of TBT: Burke: “caesareans...nowadays cost

nothing in terms of maternal

mortality, morbidity or

economically”

De Leeuw and Schutte: papers

from Holland noted 4 deaths

associated with elective breech

caesarean section between 2000

and 2002



‘Safe’

reintroduction of

Vaginal Breech

Birth



The things that the TBT didn’t teach us

What is the role of planned, worked up vaginal breech delivery in a developed country with fast access to emergency CS if needed?

How can we reinstate VB in Australia to achieve the high standards prescribed by the PREMODA group as well as training obstetricians to be confident and competent? in face of: Low volume of births

Large distances between „breech‟ units

Potential resource implications

Graduating trainees: 47% don‟t feel confident and 89% don‟t plan to offer it as specialists Chinnock 2007



Lawson et al. Birth March 2012

From 2002 onwards papers have attacked the TBT but the majority of the obstetric workforce have ignored them...

Further deconstruction of

the TBT:

Clinical guidelines at odds with

standard obstetric practice

Numerous VBACs

Criteria for “usual” standard of

care very suspect – would

generally rate as “substandard”

by most definitions



The John Hunter

experience



John Hunter Hospital (Newcastle, NSW)

Large metropolitan hospital that continued to selectively

offer VB for singleton breech presentation

Stringent criteria throughout regarding: selection;

management of labour and delivery

Approximately 400 breech births including many

interstate clients due to lack of accommodation within

the public sector in the majority of public hospitals.

Current audit underway to evaluate maternal and

neonatal outcomes of this service between January

1999 and August 2010 in comparison to the international

published literature.



Royal Hospital for Women, Sydney

Vaginal Breech service introduced – too early for audit

Widespread acceptance amongst consumers and

midwives, mixed response from obstetricians

Vaginal Breech Birth now offered or under

consideration:

John Hunter Hospital


Westmead

Royal Prince Alfred (informal)



Breech Counseling @ the




Further Opinion: Most recent O&G MagazineDr Henry Murray FRANZCOG CMFM



Breech Conference at the Royal Hospital for

Women late 2012

International Expert: Frank Louwen from Frankfurt

Presentation from Dr Bisits of the JHH Breech Audit

Open invitation: in particular legal attendance welcome

However there will be no specific “medico-legal”

sessions: the starting point of this meeting is that

selected vaginal breech is safe, evidence based and not

in need of special medico-legal consideration.



Conclusions

There was never convincing evidence to abandon

vaginal breech birth

Vaginal breech birth is safe for appropriately selected

cases (and those selected out are relatively few)

Our greatest danger is now having an insufficiently

trained workforce

Women are being forced to travel interstate or pay for

private obstetric care to achieve a vaginal breech birth



Any questions?

Lawson. The Term Breech Trial Ten Years On: Primum Non Nocere? Birth 39:1 March 2012

Lawson. Report of a Breech Cesarean Section Maternal Death. Birth 38:2 June 2011

Goffinet et al for the PREMODA Study Group. Is planned vaginal delivery for breech presentation at term still an option? AmJOG 2006:194: 1002-11

Van Roosmalen. Commentary. There is still room for disagreement about vaginal delivery of breech infants at term

Glezerman. Five years to the term breech trial: The rise and fall of a randomized controlled trial. AmJOG 2006; 194: 20-5

Keirse. Evidence-Based Childbirth Only for Breech Babies. Birth 29:1 March 2002.

Burke. The end of vaginal breech delivery. BJOG 2006; 113:969-972

Rietberg. The effect of the Term Breech Trial on medical intervention behaviour and neonatal outcome in the Netherlands: an analysis of 35,453 term breech infants. BJOG 2005; 112:205-209

Hannah et al. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Lancet 2000; 356:1375-83

Whyte et al. Outcomes at 2 years after .....AmJOG 2004; 191:864-71

Hannah et al. Maternal outcomes.....AmJOG 2004; 191: 917-927

References:



medico-legal perspectives on the reintroduction of vaginal breech births

Health & Medicine

vaginal breech birth

s vaginal birth vb

workforce issues

tbt perinatal mortality

complete breech atterm

cs planned vb

tbt centres

cs risks