Professor Michael Permezel - RANZCOG - Bad outcomes in Maternity Care: Do Obstetricians intervene enough?

Michael Permezel

Medico-legal Forum

Melbourne, June 2015

Informed Consent for Maternity Care

Are we doing enough?


Consent and the Law Prac00oners may breach their duty of care to pa0ents if they fail to warn them of the risks inherent within a proposed treatment.

Bridie Woolnough, Resolu0ons Officer, HCC NSW


Consent and the Law

What Risks?


Bolam v Friern Hospital Management Committee (1957)



Material Risk Material risk is any risk, which a reasonable person in the pa0ent’s situa0on, would aHach significance to.

Rogers v WhiHaker

Planned Vaginal Birth

Informed Consent?


Informed Consent?

Are Women currently informed of the “Material Risks” of Planned Spontaneous Vaginal Birth?

Obstetricians preparedness to perform Caesarean Sec0on on Maternal Request

Habiba et al 2006

Caesarean Section on Maternal Request

Country ‘patient choice’

UK 79%

Germany 75%

Italy 55%

Sweden 49%

France 19%

Spain 15%

Obstetricians preparedness to perform Caesarean Sec0on on Maternal Request

Habiba et al 2006

CS on Maternal Request

Country ‘patient choice’ ‘previous traumatic VD’

‘previous IP stillbirth’

UK 79% 99% 98%

Germany 75% 97% 94%

Italy 55% 78% 81%

Sweden 49% 94% 90%

France 19% 77% 67%

Spain 15% 38% 60%

Neonatal RDS

Maternal Index Pregnancy

Maternal Subsequent Pregnancy

Childhood Asthma Pelvic Floor Damage

Perinatal Morbidity & Mortality

Breast Feeding

Postnatal Depression

The Risk – Benefit Equation …

Psychological

Favouring Planned Vaginal Delivery

Neonatal Respiratory Distress Childhood Asthma Maternal Index Pregnancy Maternal Subsequent Pregnancy

Planned Vaginal Birth versus Elec;ve Caesarean Sec;on




Planned Vaginal Birth versus Elec0ve Caesarean Sec0on

Neonatal Respiratory Distress Ven0la0on in 1st 24 hr

1 neonatal death in 24,077 repeat CS at term; Tita et al, NEJM 2009

Neonatal Ventilation after Elective CS

1.9%

0.9%

0.4% 0.4% 0.4%

0.0%

0.4%

0.8%

1.2%

1.6%

2.0%

37 38 39 40 41

Gestation Weeks

% re

quiri

ng v

entil

atio

n


Favouring Vaginal Delivery



Childhood Asthma

Thavagnanam et al 2008





Maternal Morbidity – Index Pregnancy

Planned CS Planned VB OR PPH Transfusion 0.2 % 0.7 % 0.4 Anaes complica0on 5.3 % 2.1 % 2.3 VTE 0.6 % 0.3 % 2.2 Infec0on 6.0 % 2.1 % 3 Length of stay 3.9 days 2.5 days BUT …………

CIHI data on 2.5 million births between 1991-‐2005 Elec0ve CS were all planned elec0ve CS for breech presenta0ons -‐ more fibroids, uterine abnormality, placenta praevia -‐ 16-‐17% ‘probably’ laboured (ie emerg CS in elect CS group)

Liu et al 2007


Maternal Mortality – Index Pregnancy

El CD 0 / 47,776 Pl VD 41/ 2,292,420

Liu et al, 2007


Maternal Mortality – Index Pregnancy Vaginal Delivery 0.03/1000 Elec0ve Caesarean Sec0on 0.07/1000

•  Lilford 1987


Maternal Mortality – Index Pregnancy Vaginal Delivery 0.03/1000 Elec0ve Caesarean Sec0on 0.07/1000 Emergency Caesarean Sec0on 0.27/1000 Planned VD, 17% Emerg CS 0.07/1000

Bingham & Lilford 1987





Maternal Morbidity – Subsequent Pregnancy Placenta Accreta aker Caesarean Sec0on

Silver 2006, Grobman 2007

CS # Praevia (%) Accreta (%) Hysterectomy (%)

Primary 0.3 0.2 0.6

Second 0.7 0.3 0.4

Third 1.8 0.6 0.9

Fourth 3 2.1 2.4

Fifth 10 2.3 3.5

CDMR

Median Family Size in OECD Countries

Australian Ins0tute of Family Studies, 2008





Primary 0.3 0.2 0.6

Second 0.7 0.3 0.4

Third 1.8 0.6 0.9

Fourth 3 2.1 2.4

Fifth 10 2.3 3.5





Primary 0.3 0.2 0.6

Second 0.7 0.3 0.4

Third 1.8 0.6 0.9

Fourth 3 2.1 2.4

Fifth 10 2.3 3.5





Primary 0.3 0.2 0.6

Second 0.7 0.3 0.4

Third 1.8 0.6 0.9

Fourth 3 2.1 2.4

Fifth 10 2.3 3.5

Neonatal RDS

Maternal Index Pregnancy

Maternal Subsequent Pregnancy

Childhood Asthma Pelvic Floor Damage

Perinatal Morbidity & Mortality

Breast Feeding

Postnatal Depression

The Risk – Benefit Equation …

Psychological


Favouring Elec0ve Caesarean Sec0on

Pelvic Floor Damage

Perinatal Mortality & Morbidity

Is he the Cause?



Pelvic Floor Damage Urinary Incon0nence Anal Incon0nence Pelvic Organ Prolapse


Major Pelvic Floor Dysfunc0on

Odds Ra0o rela0ve to Nullipara

Caesarean Sec0on 2.5 (1.5-‐4.3)

Spontaneous VD 3.4 (2.4-‐4.9) Instrumental VD 4.3 (2.8-‐6.6)

Odds ra0on rela0ve to Nullipara; Any type of Incon0nence, Prolapse Symptoms or Prolapse Surgery

MacLennan AH et al 2000


Urinary Incon0nence


Urinary Incon0nence Term Breech Trial

Planned CS Planned VB at 3/12

36 / 798 (4.5%) 58/797 (7%)* at 2 years 81 / 457 (18%) 100/460 (22%)

Urinary Incon0nence↑ with VD at 3/12 but not at 2 years

*p < 0.05 Hannah et al, 2002; Hannah et al, 2004

Urinary Incon0nence EpinCont Study

Increased Urinary Incon0nence with VB

p < 0.05; 15,307 women in the Epidemiology of Incon0nence in the County

of Nord-‐Trøndelag, Norway, Rortveit et al 2003


Nulliparous Caesarean Section

Vaginal Birth

Any Incontinence 10% 16% 24%

Moderate or Severe

4% 6% 10%


Anorectal Incon0nence (Short-‐Term)

Planned Vaginal Birth versus Elec0ve Caesarean Sec0on Anorectal Incon0nence – Short term


Anorectal Incon0nence – Short Term System Review

* assumes 13% instrumental birth; Systematic review; Pretlove SJ et al, 2010

OR 95% CI

Forceps 2.01 (1.47-‐2.74)

Vacuum 1.60 (1.07-‐2.40)

Spontaneous Vaginal 1.32 (1.04-‐1.68)

All Vaginal* 1.40


Anorectal Incon0nence (Long-‐Term)


Anal Incon0nence – Long term (14 years)

Samesekara et al, 2008

VD associated with 3rd degree tear

Uncomplicated VD

Elective CS

Length of follow up (years)

14.8 14.2 14.2

Prevalence of any anal incontinence

53% 19% 11%

Cleveland Anal incontinence score

3.5 1.3 0.6

Quality of life scores êê ê − Persistent defect in sphincter on EAS

59% 4% 0%


Anorectal Incon0nence – Long term

Gyhagen 2014; Faecal Incontinence 20 years after one birth


Anorectal Incon0nence – Long term



Anorectal Incon0nence – Long term (20 years)

n VD % CS % OR 95% CI

Anorectal Incon0nence 2425 48.3 42.8 1.25 (1.10–1.43)

Faecal Incon0nence 701 14.5 10.6 1.43 (1.16–1.77)

Solid 245 5.1 3.4 1.54 (1.08–2.17)

Liquid 660 13.9 9.4 1.53 (1.23–1.90)

*Adjusted for maternal age; current BMI and infant birthweight



Pelvic Floor -‐ Summary

Urinary Incon0nence Definite benefit of CS

Anorectal Incon0nence Definite benefit of CS

More so with increased 0me since the Birth



Pelvic Floor Damage Perinatal Morbidity and Mortality


Perinatal Death “There has to be a very good reason for NOT doing something

that might save the life of a child”

Jonathon Glover; Ethicist; In: Humanity A Moral History of the Twen0eth Century

662,043 singleton births, Victorian Perinatal Data Collection Unit (1992-2002)

When do babies die?

Ingemarssson 1997; Vashevnik, Walker & Permezel 2007

Perinatal Death

0.00%

0.05%

0.10%

0.15%

0.20%

0.25%

0.30%

0.35%

36 37 38 39 40 41 42 43

Gestation

Perin

atal

Dea

ths

each

Wee

k of

Bab

ies

in

Ute

ro

Sweden 1982-1991 Victoria 1991-2002

Ingemarssson 1997; Vashevnik 2007

17%

Ingemarssson 1997; Vashevnik 2007

24%


Perinatal Death (Late Antenatal and Intrapartum)

> 39 weeks’ gesta0on = 1.93 / 1000

Ingemarsson 1997; Vashevnik, Walker & Permezel, 2005



>39 weeks’ gesta0on = 1.93 / 1000

Much less common aker Elec0ve CS

Only 3 Perinatal Deaths aker 5,966 Elec CS 1999-‐2009 (one of which was severe Cong. CMV and one late Neonatal Death in

mother on Rx for Long QT)

Permezel & Milne, JOGR 2015




> 39 weeks’ gesta0on = 1.93 / 1000

i.e. elec0ve CS at 39.0 weeks will prevent a perinatal death in 1/500 ongoing pregnancies




Cerebral Palsy ….

The Damaged Baby. Who is at Fault? Infection

5%CVA10%

Intrapartum10%

Other5%

Antenatal Hypoxia

50%

Congenital20%

> 2500 g, Grether and Nelson 1997

The Damaged Baby. Who is at Fault?

Other5%

Congenital20%

Antenatal Hypoxia >38w ?%

Antenatal Hypoxia <38w?%

Intrapartum10%

CVA10%

Infection5%

Modified from > 2500 g, Grether and Nelson 1997


Cerebral Palsy

Term Hypoxic Ischaemic Encephalopathy 1,2 2 / 1000 (Moderate or Severe)

1Badawai et al, 1998 – WA cohort – 3.8/1000; 1Palsdoxr, 2007 – Iceland – 1.4/1000;

Hypoxic-‐Ischaemic Encephalopathy Cerebral Palsy Outcome in HIE Survivors

Carli G, Reiger I, Evans N. 2004; Smith J et al 2000; Amile-‐Tieson 1986; Levene et al 1986

5%

25%

75%

0%

25%

50%

75%

HIE grade I HIE grade II HIE grade III


Cerebral Palsy

Hypoxic Ischaemic Encephalopathy 1,2 2 /1000 (Moderate or Severe)

HIE & Cerebral Palsy 3,4 0.6/1000

(using HIE G2 -‐>25% CP & HIE G3 -‐> 75% )

1Badawai et al, 1998 – WA cohort – 3.8/1000; 1Palsdoxr, 2007 – Iceland – 1.4/1000; 3Graham 2008; 4Blair & Stanley;

Mode of Delivery and HIE

Badawi et al, 1998

0

5

10

15

20

25

30

35

40

45

Electivecaesarean

section

Spont. vaginal Inducedvaginal

Instrumentalvaginal

Emergencycaesarean

section

Breechmanoeuvre

Mod

e of

Del

ilver

y (%

)HIE No HIE


Cerebral Palsy




Cerebral Palsy (Elec Caes) 1 0.1/1000 (using 15% CP elec CS cf other term births 3)


Planned Vaginal Birth versus Elec;ve Caesarean Sec;on Cerebral Palsy




Cerebral Palsy (Elec Caes) 1 0.1/1000 (using 15% CP elec CS cf other term births 3)

Cerebral Palsy (avoided by Elec CS) 1 0.4/1000 (less 23% for births 37.0 – 38.6w)




Brachial Plexus Palsy ….

Planned Vaginal Birth versus Elec;ve Caesarean Sec;on Brachial Plexus Palsy (permanent aker shoulder dystocia with vaginal birth)*

Trondheim, Norway Baske et al, 2008 0.5 / 1000 Los Angeles, USA Gherman et al 1998 0.1 / 1000 Glaveston, USA Chauhan et al, 2005 0.1 / 1000

* Rates of temporary BPP approximately 6x greater


Perinatal Mortality or Long Term Serious Morbidity Mortality 1.9 /1000 Cerebral Palsy 0.4 /1000 Permanent Brachial Plexus Palsy 0.2 /1000 Addi0onal Perinatal Death / Disability 2.5 /1000

(1/400)


Is 1/400 a “Material Risk”?

N= 600, >36 weeks’ gestation Preliminary written information

Risks in everyday life Risks in pregnancy Unavoidable risk of stillbirth at term (3:10,000)

Visual probability aid

Portrayed varying levels of extra risk (1:10,000-1:50)

‘if the increased risk of serious harm to the baby with vaginal delivery was greater than 1 in…., I would prefer delivery by caesarean section’

What level of Fetal Risk (with attempted Vaginal Birth) do Patients regard as an Indication for Caesarean Section?

Midwives: Median 1: 1000 “If the additional fetal risk of vaginal delivery was greater than ‘ 1in x ’,

then I would recommend a Caesarean section”

Walker SP et al, RANZCOG ASM, 2006

Obstetricians: Mean 1: 750 “If the additional fetal risk of vaginal delivery was greater than ‘ 1in x ’,

then I would recommend a Caesarean section”

Walker SP et al, RANZCOG ASM, 2006

A Paradox for Maternity Carers …


So for most women, nearly all obstetricians and most midwives …………..

Informed Consent for Planned Vaginal Birth ?

So for most women, nearly all obstetricians and most midwives ………….. “Perinatal Risks of Planned VD aker 39 weeks’ (1 in 400) exceeds The risk they define as acceptable to avoid CS” (1 in 750)

Awai;ng Spontaneous Labour

Informed Consent?


Informed Consent?

There is a duty of care upon the provider of maternity care to inform of the “Material Risks”

of “Awai0ng Spontaneous Labour”


The Evidence

Awai;ng Spontaneous Labour – Informed Consent?

Postdates Pregnancy

Informed Consent for Awai0ng Spont. Labour?

Await Spontaneous Labour – Informed Consent?

Induc0on of Labour – 41.0 weeks’

Key Findings Caesarean sec0on ↓ Perinatal mortality ~

Hannah et al 1992


Macrosomia

Informed Consent for Awai0ng Spont. Labour?


Induc0on of Labour – Macrosomia

Key Findings Birthweight ↓ Shoulder Dystocia ↓ Caesarean Sec0on ~ Spontaneous Vaginal Birth ↑

Boulvain et al 2015


Gesta0onal Hypertension


Induc0on of Labour – Gesta0onal Hypertension at 37 weeks’

Key Findings

Hypitat 2009

Caesarean sec0on 0·∙75 (0·∙55–1·∙04) (p =·∙085)

Composite Adverse Maternal Outcome 0·∙71 (0·∙59–0·∙86) (p<0·∙0001)

Composite adverse Neonatal Outcome 0.75 (0.45-‐1.26) (p=0.28)


“Lower Risk” Pregnancy


Perinatal Death

0.00%

0.05%

0.10%

0.15%

0.20%

0.25%

0.30%

0.35%

36 37 38 39 40 41 42 43

Gestation

Perin

atal

Dea

ths

each

Wee

k of

Bab

ies

in

Ute

ro

Sweden 1982-1991 Victoria 1991-2002


Are these late Perinatal Deaths avoidable by IOL?

Only 3 Perinatal Deaths aker 12,773 IOL at MHW 1999-‐2009

1 / 4000



Are these late Perinatal Deaths avoidable by IOL?

3 Perinatal Deaths aker 12,773 IOL 1/ 4000

57 Perinatal Deaths in 25,789 Spontaneous Labours or FDIU awai0ng Spontaneous Labour

1/450

MHW 1999-‐2009; Permezel & Milne, JOGR 2015



Rou0ne IOL?

3 Perinatal Deaths aker 12,773 IOL 1/ 4000 NOTE: a policy of rou0ne IOL would include high heads and unfavourable Cx

57 Perinatal Deaths in 25,789 Spontaneous Labours or FDIU awai0ng Spontaneous Labour

1/450 NOTE: not all prevented by rou0ne IOL as some before scheduled IOL

MHW 1999-‐2009; Permezel & Milne, JOGR 2015



“Low Risk” Models of Care


Maternity Care – Informed Consent?

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

"Mixed Risk" "Low Risk"

31.0

15.8

30.4

12.4 15.6

12.3

Obs

tetri

c In

terv

entio

n (%

)

Obstetric Intervention in Mixed Risk and Low Risk Models of Care

Induction Rate Caesarean Section Rate Instrumental Delivery Rate






The Second Paradox “Mixed Risk – High Interven0on Care”

Meant to be the more complex cases BUT lower Ap5 < 7 and lower perinatal mortality

“Low Risk – Low Interven0on Care”

Meant to be the less complex cases BUT higher Ap5 < 7 and higher perinatal mortality

Summary

Birth -‐ Informed Consent?

Key Points


1. Rate of “preventable” Serious Adverse Perinatal Outcomes


1. Rate of Serious Adverse Perinatal Outcomes

~ 1 / 400 have a serious adverse outcome > 38w (that would be mostly avoided by elec0ve CS)


2. Rate of Serious Maternal Adverse Outcomes


2. Rate of Serious Maternal Adverse Outcomes

Vs

Pelvic Floor Damage Placenta Accreta


3. Women are diverse in their Priori0es for Birth


3. Women are diverse in their Priori0es for Birth

some prioritise fetal welfare at any cost

others prioritise low intervention


4. Models of Care cater for that diversity in Priori0es for Birth


4. Models of Care cater for that diversity in Priori0es for Birth


5. Informed Consent

Informed Consent in Maternity Care must alert women to the “Material Risks” of all management including those of

“Awai0ng Spontaneous Labour”

Thank You

Informed Consent in Maternity Care


Professor Michael Permezel - RANZCOG - Bad outcomes in Maternity Care: Do Obstetricians intervene enough?

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