Israeli Family Physicians: what Israeli Family Physicians: what to know?to know?

Throwing the Mother Out with the Throwing the Mother Out with the Bathwater—Misuse of randomized Bathwater—Misuse of randomized

controlled trialscontrolled trials

Michael C. Klein Michael C. Klein Centre Community Child Health ResearchCentre Community Child Health ResearchBC Research Institute for Children’s and BC Research Institute for Children’s and

Women’s HealthWomen’s Health Emeritus Professor of Family Practice and Emeritus Professor of Family Practice and

Pediatrics Pediatrics University of British Columbia University of British Columbia

Variation surfaces—BC Women’s Variation surfaces—BC Women’s Hospital 1993-----Hospital 1993-----

25 docs 75% or more

Family Physicians Nullip SVD Family Physicians Nullip SVD Episiotomy RatesEpisiotomy Rates

Apr 95-Mar 96: mean rate=19.2Apr 95-Mar 96: mean rate=19.2Apr 96-Mar 97: mean rate=14.9Apr 96-Mar 97: mean rate=14.9

AApril 98-Mar 99pril 98-Mar 99

Episiotomy Rate (%)

Num

ber o

f Phy

sician

s

60

50

40

30

20

10

0

Std. Dev = 21.78

Mean = 13.1

N = 96.00564478

53

2 remaining

Variation surfaces Variation surfaces Vancouver CQI 1993Vancouver CQI 1993

Does Epidural Does Epidural Analgesia Increase the Analgesia Increase the Likelihood of Cesarean Likelihood of Cesarean

Section?Section?How many think it does?How many think it does?

How many think it does How many think it does not?not?

Epidural Cxion Epidural Cxion

A natural experiment at nearby A natural experiment at nearby community hospitalcommunity hospital

In early 1990s Community Hospital had Cxion rate of In early 1990s Community Hospital had Cxion rate of about 8%, while Women’s about 20%about 8%, while Women’s about 20%

We Created matched cohort of healthy womenWe Created matched cohort of healthy women Odds of having a Cxion at the tertiary care centre vs Odds of having a Cxion at the tertiary care centre vs

community 3.4 (CI 2.1—5.4)community 3.4 (CI 2.1—5.4) Why?Why?

More advanced cervical dilation on arrival (opportunity for More advanced cervical dilation on arrival (opportunity for doulas)doulas)

Use of epidural analgesia—largest effect: Epidural rate of Use of epidural analgesia—largest effect: Epidural rate of 15.4% 15.4% community, 67.2% tertiarycommunity, 67.2% tertiary

Janssen P, Klein MC. Janssen P, Klein MC. Differences in Institutional Cesarean Differences in Institutional Cesarean Delivery Rates: The role of pain management. J Fam Delivery Rates: The role of pain management. J Fam Pract 2001; 50(3):217-223Pract 2001; 50(3):217-223

A natural experiment at A natural experiment at nearby community nearby community

hospitalhospital Differences between the hospitals:Differences between the hospitals: Increased ambulation at the community Increased ambulation at the community (12% vs 5%)(12% vs 5%) Fewer numbers of caregivers for each woman at Fewer numbers of caregivers for each woman at

communitycommunity More oxytocin augmentation at community More oxytocin augmentation at community

(32.3 vs 24.9%)(32.3 vs 24.9%) Less offering of epidural at community (qualitative) Less offering of epidural at community (qualitative)

16.7% vs 42.3% 16.7% vs 42.3% Strong Head of OB at community who worked Strong Head of OB at community who worked

collaboratively with strong nursing and FP leadership, collaboratively with strong nursing and FP leadership, and together developed a coherent philosophy of care and together developed a coherent philosophy of care

A natural experiment at A natural experiment at nearby community nearby community

hospitalhospital But when controlled for epidural, the But when controlled for epidural, the Cxion rate at the Cxion rate at the

two hospital was the same, about 12%two hospital was the same, about 12% In other words, women with an epidural in each facility In other words, women with an epidural in each facility

had a similarly had a similarly highhigh Cxion rate and women Cxion rate and women notnot receiving receiving an epidural had a similarly an epidural had a similarly lowlow Cxion rate Cxion rate

Only real difference was: community hospital used Only real difference was: community hospital used epidural less often, and in so doing had a low Cxion rateepidural less often, and in so doing had a low Cxion rate

When Head of OB retired and nursing leadership also When Head of OB retired and nursing leadership also changed, the epidural and Cxion rate at the community changed, the epidural and Cxion rate at the community hospital rapidly reached usual levels for BChospital rapidly reached usual levels for BC

Janssen P, Klein MC. Janssen P, Klein MC. Differences in Institutional Cesarean Delivery Rates: The Differences in Institutional Cesarean Delivery Rates: The role of pain management. J Fam Pract 2001; 50(3):217-223role of pain management. J Fam Pract 2001; 50(3):217-223

Meanwhile Departmental CQI Meanwhile Departmental CQI evolved into researchevolved into research

We studied natural variation in We studied natural variation in relation to physician epidural ratesrelation to physician epidural rates Maternal outcomesMaternal outcomes Newborn outcomesNewborn outcomes The physician rather than the woman as The physician rather than the woman as

the unit of analysisthe unit of analysis

Nulliparous Maternal Nulliparous Maternal Outcomes by Epidural Outcomes by Epidural

CohortsCohorts

19.314.1

66.5

23.2

12.2

21.9 19.9

58.2

35.5

25.3

54.9

24.420.7

34.2

29.8

0

10

20

30

40

50

60

70

OP/OT Augment Forc/Vac SVD Cxion

Low Epidural

Mid Epidural

High Epidural

Nulliparous Malposition (OP-Nulliparous Malposition (OP-OT) OT)

Rates by Epidural by RaceRates by Epidural by Race

17

23.2

26.3

34.736.635.5

33.1

34.236.6

0

5

10

15

20

25

30

35

40

Low Epidural

Mid EpiduralHigh Epidural

Nulliparous Oxytocin Nulliparous Oxytocin Augmentation Rate by Epidural Augmentation Rate by Epidural

Cohorts by RaceCohorts by Race

14.8

12.210.9

24

2725.4

30.529.828.2

0

5

10

15

20

25

30

35

Low Epidual

Mid Epidural

High Epidural

Nulliparous Cesarean Nulliparous Cesarean Rate by Epidural Cohorts Rate by Epidural Cohorts

by Race by Race

20.1

12.614.1

17

19.9

19

20.6

24.426.2

0

5

10

15

20

25

30

All Caucasian Non-Caucas

Low Epidual

Mid Epidural

High Epidural

p values range from <.001 overall to .034 for caucasians and .049 for non-caucasians

Epidural studyEpidural study

Nulliparous NCN/SCN Admission Nulliparous NCN/SCN Admission Rates by Epidural by RaceRates by Epidural by Race

6.87.2 7.4

7.7

9.18.3

12.412.8

13.7

0

2

4

6

8

10

12

14

16

Low EpiduralMid EpiduralHigh Epidural

p values range from .012 overall to .193 for caucasians and .064 for non-caucasians

Were the physicians who were in Were the physicians who were in each epidural cohort practicing each epidural cohort practicing

differently?differently? Not only did they use epidurals less often, Not only did they use epidurals less often,

butbut Used epidurals laterUsed epidurals later Spent more time with their patients in Spent more time with their patients in

hospital--even though their patients spent less hospital--even though their patients spent less time in hospitaltime in hospital

Indeed they practiced differently—more Indeed they practiced differently—more intimacy and engagementintimacy and engagement

Conclusion:

•Physicians who employ epidural analgesia often (and early) in labor expose them to higher intervention rates and more adverse maternal and newborn outcomes than those who on average employ epidural analgesia less often and later in labor.

But not the fault of the anesthesia establishment at But not the fault of the anesthesia establishment at BC Women’s or likely elsewhere.BC Women’s or likely elsewhere.

Anesthesia provides an excellent service. They help Anesthesia provides an excellent service. They help us resolve many problemsus resolve many problems

It is It is wewe who ask for help!!!!!!!!! who ask for help!!!!!!!!! At least at BC Women’s, there is no evidence that At least at BC Women’s, there is no evidence that

anesthetists are scavenging for businessanesthetists are scavenging for business There is evidence from rural family practice (Stuart There is evidence from rural family practice (Stuart

Iglesias) that epidurals can be introduced and Iglesias) that epidurals can be introduced and associated with lowering of Cxion rateassociated with lowering of Cxion rate But that study requires contextual or environmental analysisBut that study requires contextual or environmental analysis

The Tyranny of The Tyranny of Meta-analysisMeta-analysis

And the And the misuse of misuse of

Randomized Randomized Controlled Controlled

TrialsTrials

Collateral damage Collateral damage or Blowby—think or Blowby—think

IraqIraqOr throwing the mother (and at Or throwing the mother (and at

times the baby) out with the times the baby) out with the bathwater.bathwater.

Or consequences of left-sided Or consequences of left-sided thinking—what about the right thinking—what about the right side (think right brain)side (think right brain)

David Sackett: David Sackett: understanding clinical understanding clinical

trials. trials. BMJ 309: 1994BMJ 309: 1994 Information from trials Information from trials

“….should go far beyond “….should go far beyond efficacy…to include measures of efficacy…to include measures of harm as well as benefit and to harm as well as benefit and to integrate patient’s views on the integrate patient’s views on the quality of life quality of life with and without with and without treatmenttreatment, and to include , and to include economic consequences of the economic consequences of the treatment alternatives.”treatment alternatives.”

Cochrane Meta-analysis of Effect of Cochrane Meta-analysis of Effect of Epidural AnalgesiaEpidural Analgesia

Comparing Epidural to NarcoticsComparing Epidural to Narcotics Previously meta-analyses showed a 10% increase in Previously meta-analyses showed a 10% increase in

Cxion rate with epidural analgesiaCxion rate with epidural analgesia Current Cochrane does not—why not? Is Cochrane Current Cochrane does not—why not? Is Cochrane

wrong?wrong? It is not the fault of the RCT as a methodology!!It is not the fault of the RCT as a methodology!! It is the inclusion in the meta-analysis of studies that It is the inclusion in the meta-analysis of studies that

ought not to be there—or the ought not to be there—or the studies need to be studies need to be grouped or stratified according to their settings or grouped or stratified according to their settings or approaches so one can know if the results apply to approaches so one can know if the results apply to one’s own settingone’s own setting

Central Concepts in Central Concepts in Applicability of EBMApplicability of EBM

Look at both the left and the right Look at both the left and the right side of the equationside of the equation

What about the “inadvertent” What about the “inadvertent” consequences of the approach or consequences of the approach or procedure addressed by the trial procedure addressed by the trial or or what what youyou are interested in compared to are interested in compared to the the big picture consequences for this big picture consequences for this and future pregnancies?and future pregnancies?

4.3 hour increase with epidural

Sharma only 1 hour increase with epidural

1.4 hour increase with epidural

Sharma only 19 min increase with epidural

52%

38%

Sharma only 33% epidural 15% control

15% 7%

Increase in Perineal trauma as well

27% 16%

Sharma only 9.1% epidural versus 3.6% control

24% 6%

Why not an Why not an increase in increase in cesarean as well?cesarean as well?

Sharma: Dallas Parkland 12% base Cxion rate, low dose oxy augmentation, Randomization @4-5cms. Clark: Louisville, 70%>4 cms, high dose oxy, Loughan: London UK Randomization 3-4cms,

Sharma!!!!

All studies: mixed parity, various concentrations of agents both study arms and mostly IM narcotic

5% both arms

10-14%12-13%

Klein Sensitivity Analysis: retaining only those studies that randomized early at < 4-5 cms

Wong CA, Scavone BM, Peaceman AM, Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, et al. The McCarthy RJ, Sullivan JT, Diaz NT, et al. The risk of cesarean delivery with risk of cesarean delivery with neuraxialneuraxial analgesia given early versus late in labor. analgesia given early versus late in labor. N Engl N Engl J MedJ Med 2005;352: 655-65 2005;352: 655-65

Authors and NEJM editorialist claimed that early Authors and NEJM editorialist claimed that early epidurals do not increase the rate of caesarean epidurals do not increase the rate of caesarean deliveries. deliveries.

The study was not of early epidural analgesia, and the The study was not of early epidural analgesia, and the oxytocin augmentation rate of 75% at first analgesia oxytocin augmentation rate of 75% at first analgesia makes for lack of generalisability. makes for lack of generalisability.

The claim that women need not worry that early The claim that women need not worry that early epidurals will lead to increased caesareans is false.epidurals will lead to increased caesareans is false.

This trial was about two methods of This trial was about two methods of helping women with pain in helping women with pain in early labourearly labour. .

In the so called epidural arm, an In the so called epidural arm, an epidural epidural catheter was placedcatheter was placed. On first request for . On first request for analgesia, women received intrathecal analgesia, women received intrathecal fentanyl, and in the narcotic arm, fentanyl, and in the narcotic arm, hydromorphone. hydromorphone.

On second request, almost two thirds of On second request, almost two thirds of women in both arms were in active labour, women in both arms were in active labour, 4 cm or more dilated. 4 cm or more dilated.

In the intrathecal "epidural" arm, they In the intrathecal "epidural" arm, they received low dose epidurals; in the received low dose epidurals; in the narcotic arm, hydromophone. narcotic arm, hydromophone.

This trial, as others that have contributed to the This trial, as others that have contributed to the Cochrane meta-analysis showed no increase in Cochrane meta-analysis showed no increase in caesareans in the presence of epidural analgesia, but caesareans in the presence of epidural analgesia, but does not acknowledge that most women were in active does not acknowledge that most women were in active labour at time of second request or when they actually labour at time of second request or when they actually got an epidural-- when most will do well. got an epidural-- when most will do well.

Wong et al, like Sharma et al, the other major Wong et al, like Sharma et al, the other major contributors to the Cochrane meta-analysis showing no contributors to the Cochrane meta-analysis showing no difference, have shown only that when women's pain in difference, have shown only that when women's pain in the the latent phaselatent phase is managed with intrathecal, narcotic, or is managed with intrathecal, narcotic, or other pharmacological or non-pharmacological means, other pharmacological or non-pharmacological means, an an epidural in the active phase of labour does not epidural in the active phase of labour does not increase the rate of caesarean section. increase the rate of caesarean section.

And neuraxial analgesia. MmmmmmmmmmmmmmAnd neuraxial analgesia. Mmmmmmmmmmmmmm

Ohel from Israel Ohel from Israel (Am J Obs and Gyn 2006 vol 194)(Am J Obs and Gyn 2006 vol 194)

Well conducted RCT of Epidural vs NarcoticsWell conducted RCT of Epidural vs Narcotics 449 nulliparous women at term randomized at less 449 nulliparous women at term randomized at less

than 3 cmsthan 3 cms Mean point of randomization 2.6 vs 4.6 cms for Mean point of randomization 2.6 vs 4.6 cms for

epidural vs narcotic epidural vs narcotic CS 13% vs 11% (LOW!!!!!!!!!!!!!)CS 13% vs 11% (LOW!!!!!!!!!!!!!) But labor supported by nurse midwives fully—But labor supported by nurse midwives fully—

Obstetricians only as consultantsObstetricians only as consultants Clearly an intimate style of careClearly an intimate style of care Again it is about environment—yours?Again it is about environment—yours?

Latest Meta-analysesLatest Meta-analyses

Patient-requested Neuraxial Patient-requested Neuraxial Analgesia for Labor--Analgesia for Labor--Marucci et al Marucci et al Anesthesiology May 2007Anesthesiology May 2007 Review comes up with the same conclusions Review comes up with the same conclusions

based on the same literaturebased on the same literature New Cochrane meta-analysis sameNew Cochrane meta-analysis same All now state that early epidurals are not a All now state that early epidurals are not a

problemproblem

Epidural analgesia, while a superb Epidural analgesia, while a superb technology, and the “best” form of pain technology, and the “best” form of pain

relief has completely transformed relief has completely transformed normal birth--leading to a normal birth--leading to a cascadecascade of of

interventionsinterventions..• 3 of 4 Canadian women receive 3 of 4 Canadian women receive

one or more major procedures or one or more major procedures or interventions in labor (CIHI, 2004) interventions in labor (CIHI, 2004) and epidurals are a major and epidurals are a major contributing cause: Epidural Rate contributing cause: Epidural Rate 45.4% Canada, 36.3% Vancouver 45.4% Canada, 36.3% Vancouver and risingand rising

Why don’t we acknowledge that Epidural Why don’t we acknowledge that Epidural Analgesia has changed the landscape?Analgesia has changed the landscape?

•Subversion by RCTs and EBM?Subversion by RCTs and EBM?• Cochrane reviews by Cochrane reviews by

Anesthesiologists?Anesthesiologists?•Nurse/Doctor’s comfort—we like it!!Nurse/Doctor’s comfort—we like it!!•Economics?Economics?•Existence of a dedicated anesthetic Existence of a dedicated anesthetic

workforce that we workforce that we created? created? •Not the fault of the anesthesia Not the fault of the anesthesia establishment!!!!! We asked for itestablishment!!!!! We asked for it•Women asked for it Women asked for it

•(Think Twilight Sleep) (Think Twilight Sleep) •but we taught them to ask for it!but we taught them to ask for it!

From EBM to Research From EBM to Research designed to deliver designed to deliver

answers that we want to answers that we want to receive!receive!

From Evidence-based From Evidence-based decision-makingdecision-making

To what Philip Hall has To what Philip Hall has called:called:

•“Decision Based Evidence Making”

Whose Whose evidence?evidence?

• Does the study setting apply to me in my Does the study setting apply to me in my setting?setting?

Basic problems with RCTsBasic problems with RCTs Results apply only for the conditions of Results apply only for the conditions of

the trial the trial (“Murray Enkin’s first law”)(“Murray Enkin’s first law”) Are conditions my conditions?Are conditions my conditions?

• Do the participating Do the participating practitioners practice the way practitioners practice the way that I practice?that I practice?

Collateral damage or Blowby (2)Collateral damage or Blowby (2) Example: Canadian Post-Term trial Example: Canadian Post-Term trial

of of expectant management vs expectant management vs induction at 41 weeksinduction at 41 weeks Outside rarified atmosphere of the RCT, Outside rarified atmosphere of the RCT,

thinking that placenta degenerates at 41 thinking that placenta degenerates at 41 3/73/7thth weeks unleashes a cascade of weeks unleashes a cascade of “side effects” “side effects” NO! NO! EFFECTSEFFECTS---resulting in -resulting in increasedincreased not decreased cxion rates and not decreased cxion rates and consequences for next pregnancyconsequences for next pregnancy: : 8% 8% vs 44% cxion rate for nulliparous women vs 44% cxion rate for nulliparous women at BC Womensat BC Womens

Post-term trial: Post-term trial: this and subsequent this and subsequent pregnancies, increase in:pregnancies, increase in: induction, EFM, epidurals, induction, EFM, epidurals,

instrumentation, perineal trauma, instrumentation, perineal trauma, Cxions, sense of failure, parenting Cxions, sense of failure, parenting problems, postpartum DICproblems, postpartum DIC

Next pregnancyNext pregnancy: placental previa and : placental previa and other problems of placentation, other problems of placentation, abruptions, ectopics, infertility, abruptions, ectopics, infertility, stillbirths stillbirths

The Induction CascadeThe Induction Cascade

Induction requires continuous electronic fetal Induction requires continuous electronic fetal monitoring because it is considered a “high risk” monitoring because it is considered a “high risk” procedure. procedure. This is because over-stimulation of the uterus can This is because over-stimulation of the uterus can

occur and that can lead to stress on the fetus. occur and that can lead to stress on the fetus.

o Women receiving continuous electronic fetal Women receiving continuous electronic fetal monitoring are kept in bed almost all the time. monitoring are kept in bed almost all the time.

o Immobility leads to abnormal progress of labor, Immobility leads to abnormal progress of labor, which in turn leads to labour dysfunctionwhich in turn leads to labour dysfunction

Induction Cascade 2Induction Cascade 2

Continuous electronic fetal monitoring leads to Continuous electronic fetal monitoring leads to more cesarean sections, likely because of the more cesarean sections, likely because of the immobility and because abnormalities that are immobility and because abnormalities that are seen on the monitoring tracings are often seen on the monitoring tracings are often misinterpreted as “fetal distress,” and cesarean misinterpreted as “fetal distress,” and cesarean is the usual response.is the usual response.

----Labors that are induced Labors that are induced are more are more painful than labors that painful than labors that occur naturally.occur naturally.

--Hence women are --Hence women are

much more much more likely to likely to receive an receive an epidural epidural analgesic analgesic than women in than women in spontaneous spontaneous labor. labor.

Induction Cascade 3Induction Cascade 3

o Epidural analgesia gives very effective Epidural analgesia gives very effective pain relief—but “there is no free lunch!”pain relief—but “there is no free lunch!”

--Epidural analgesia causes--Epidural analgesia causes posterior posterior pituitary gland to pituitary gland to produce less natural produce less natural oxytocinoxytocin

----Epidural analgesia will Epidural analgesia will greatly prolong the first greatly prolong the first stage of labor on stage of labor on average by 3-4 hours average by 3-4 hours

Induction Cascade 4Induction Cascade 4

If given very early in labor at less than 4 centimeters If given very early in labor at less than 4 centimeters of cervical dilation (which is the case in most labors), of cervical dilation (which is the case in most labors), epidural analgesia causes abnormal positions of the epidural analgesia causes abnormal positions of the fetus, such as an extended neck rather than the fetus, such as an extended neck rather than the usual flexed position. This leads to more back labors usual flexed position. This leads to more back labors (posterior labors) and transverse or side positions. (posterior labors) and transverse or side positions.

A baby whose head is extended cannot rotate A baby whose head is extended cannot rotate and cannot easily descend in the birth canal.and cannot easily descend in the birth canal.

Epidural analgesia will increased the length of Epidural analgesia will increased the length of the second stage of labor by at least 30 the second stage of labor by at least 30 minutesminutes

Induction Cascade 5Induction Cascade 5o Epidural analgesia will lead to the Epidural analgesia will lead to the

inability of women to push effectively, inability of women to push effectively, thus leading to more use of synthetic thus leading to more use of synthetic oxytocin and need for assistance in the oxytocin and need for assistance in the delivery by use of vacuum or forceps.delivery by use of vacuum or forceps.

--The use of these --The use of these instruments in the presence of epidural instruments in the presence of epidural analgesia, and even without, will lead to more analgesia, and even without, will lead to more perineal trauperineal trau requiring stitching.requiring stitching.

--If given early in labor, --If given early in labor,

epidural analgesia will increase epidural analgesia will increase the the cesarean section rate by cesarean section rate by more more than two times over than two times over women not women not receiving epidurals receiving epidurals at all or only at all or only after 4-5 after 4-5 centimeters of cervical dilationcentimeters of cervical dilation..

Induction Cascade 6 (the Psychological Induction Cascade 6 (the Psychological cascade)cascade)

Induction changes everythingInduction changes everything

The birth process has now been moved from The birth process has now been moved from herher process to process managed and process to process managed and controlled by the caregivers and the systemcontrolled by the caregivers and the system

What takes place is largely driven by protocols What takes place is largely driven by protocols and guidelines. This is true and guidelines. This is true birthbirth controlcontrol

Induction Cascade 7 (the Psychological cascade)Induction Cascade 7 (the Psychological cascade)

She now needs She now needs managementmanagement and her fetus is potentially at risk for the and her fetus is potentially at risk for the consequences of the interventions that follow logically from the inductionconsequences of the interventions that follow logically from the induction. .

We watch her more carefully, and we will indeed find things to We watch her more carefully, and we will indeed find things to worry about. It just goes with the territory.worry about. It just goes with the territory.

(Some of those findings will be real and would have occurred anyhow (Some of those findings will be real and would have occurred anyhow due conditions present in the mother or the fetus, but others will be due conditions present in the mother or the fetus, but others will be caused by the interventions dictated by her altered state--caused by our caused by the interventions dictated by her altered state--caused by our good intentions. [In medicine we have a term for this: good intentions. [In medicine we have a term for this: iatrogenic diseaseiatrogenic disease or disease cased by doctors (or any caregiver behaving this way)]. or disease cased by doctors (or any caregiver behaving this way)].

Friendly fire or collateral damage can be the resultFriendly fire or collateral damage can be the result

o And it is not just that we professionals will feel And it is not just that we professionals will feel differently about the induced woman, but she will feel differently about the induced woman, but she will feel differently about herself. differently about herself.

Induction Cascade 8 (the Psychological Induction Cascade 8 (the Psychological cascade)cascade)

She will have begun to feel less in control, less confident, She will have begun to feel less in control, less confident, less competent, more dependentless competent, more dependent

Dependency feeds into the laboring process itself.Dependency feeds into the laboring process itself.

Increased maternal anxiety is inevitable and leads to Increased maternal anxiety is inevitable and leads to the production of stress hormones that interfere with the production of stress hormones that interfere with ands slow labor ands slow labor --And this feeds back into the --And this feeds back into the evolving evolving cascadecascade such that a sense of the joy and such that a sense of the joy and power and the transformative nature of childbirth are power and the transformative nature of childbirth are undermined.undermined.

Induction Cascade 9 (The Induction Cascade 9 (The NextNext Birth Cascade) Birth Cascade)

Now she has a uterine scarNow she has a uterine scar

o When the fertilized egg searches for a place to attach, When the fertilized egg searches for a place to attach, it can attach low down at or on the scar. it can attach low down at or on the scar.

(Scar made up of a fiber-like material (Scar made up of a fiber-like material rather than rather than the soft , juicy material of normal lining the soft , juicy material of normal lining of uterus). of uterus).

--Then the attachment of what will --Then the attachment of what will become become the developing placenta will the developing placenta will be weak and be weak and subject to pealing off as the subject to pealing off as the placenta andplacenta and

uterus grow uterus grow

Induction Cascade 10 (The Induction Cascade 10 (The NextNext Birth Cascade) Birth Cascade)

Placental Placental abruptionabruption occurs, when the placenta detaches itself occurs, when the placenta detaches itself in whole or in part, leading to severe bleeding and high in whole or in part, leading to severe bleeding and high likelihood of loss of the pregnancy. [Note that in Canada likelihood of loss of the pregnancy. [Note that in Canada ectopic pregnancy rates increased from 10/1000 to 16/1000 ectopic pregnancy rates increased from 10/1000 to 16/1000 between 1981 and 1990, parallel to the rise in the cesarean between 1981 and 1990, parallel to the rise in the cesarean section rates]. section rates].

If the fertilization occurs in the fallopian tube, the result is If the fertilization occurs in the fallopian tube, the result is ectopicectopic pregnancy--also leads to bleeding and fetal loss. pregnancy--also leads to bleeding and fetal loss.

If the attachment is placed over the inner opening of the If the attachment is placed over the inner opening of the cervix, the result is a “cervix, the result is a “placenta previaplacenta previa,” which can be an ,” which can be an emergency leading to cesarean section and a fetus at risk. emergency leading to cesarean section and a fetus at risk.

If the attachment “invades” the wall of the uterus it is If the attachment “invades” the wall of the uterus it is placenta accretaplacenta accreta. This is a placenta that will not detach at the . This is a placenta that will not detach at the birth, with very severe bleeding consequences and likely loss birth, with very severe bleeding consequences and likely loss of the uterus for future childbearing. of the uterus for future childbearing.

Induction Cascade 11 (The Next Birth Cascade)Induction Cascade 11 (The Next Birth Cascade) Adhesions secondary to the first cesarean Adhesions secondary to the first cesarean

surgery can lead later to maternal bowel surgery can lead later to maternal bowel obstructionobstruction. .

o All these complications are increased once a All these complications are increased once a woman has had the first cesarean, and if woman has had the first cesarean, and if present, make the woman more likely to have present, make the woman more likely to have problems getting pregnant the second time problems getting pregnant the second time (infertility)(infertility) and if she gets pregnant, of and if she gets pregnant, of having a having a stillbirth. stillbirth.

o Paradox: We started the induction to Paradox: We started the induction to prevent stillbirth…………………………prevent stillbirth…………………………

Post-Term trial about inductionPost-Term trial about induction

Results in huge number of women Results in huge number of women thinking that they are biologically thinking that they are biologically defective—biological nonsensedefective—biological nonsense

1000 inductions needed to possibly 1000 inductions needed to possibly prevent one stillbirth BUT at what price? prevent one stillbirth BUT at what price? This is the This is the right sideright side of the equation. of the equation. Informed consent?Informed consent?

Contributes massively to medicalization Contributes massively to medicalization of childbirth that has led some to suggest of childbirth that has led some to suggest that Cxion-on-demand is an answer—a that Cxion-on-demand is an answer—a surgical fix for a problem in caring.surgical fix for a problem in caring.

COMMENTARY ON: Lyerly et al: Values, and decision making surrounding pregnancy. Obstet Gynecol 2007;109(4):979–98 in The Patient-Centered (R)Evolution

“The risk discussion about induction for post-term pregnancy care focuses on the perceived risk of NOT inducing rather than the risk of operative delivery associated with induction. Furthermore, the risk discussion about NOT allowing spontaneous labor and primary vaginal delivery misses a full discussion of the risk of elective primary cesarean. In intrapartum care, our risk distortion is that we err on the side of intervening too much.”--Andrew Kotaska

Other Problematic RCTsOther Problematic RCTs

Walking in Labor—NEJM Walking in Labor—NEJM (1998:Bloom et al Volume 339:76-9)(1998:Bloom et al Volume 339:76-9)

Term-Breech TrialTerm-Breech Trial

Misuse Term-Breech TrialMisuse Term-Breech TrialResultsResults

Trial showed at 3 months postpartum that Trial showed at 3 months postpartum that newborn and mother better off with CS for newborn and mother better off with CS for prevention of pelvic floor problemsprevention of pelvic floor problems

(UI, Fecal Incontinence, Sexual)—(UI, Fecal Incontinence, Sexual)—generalized to generalized to vertex births.vertex births.

OBs stopped delivering breeches even before trial OBs stopped delivering breeches even before trial published—why?published—why?

But 2 year f/u shows But 2 year f/u shows no differenceno difference in any maternal in any maternal or newborn outcomes—including pelvic flooror newborn outcomes—including pelvic floor

And pelvic floor outcomes—what does it say And pelvic floor outcomes—what does it say about the resilience and self-healing properties of about the resilience and self-healing properties of pelvic floor for women experiencing vaginal birth? pelvic floor for women experiencing vaginal birth?

GBS!!!!!!!!!!!GBS!!!!!!!!!!! And think ahead to the collateral damage And think ahead to the collateral damage

caused by our obsession with caused by our obsession with GBSGBS—at —at what price to the mother for a what price to the mother for a marginal to marginal to no advantage to the baby?no advantage to the baby?

BC Women’s status pre and post case BC Women’s status pre and post case finding and now screening?finding and now screening?

More antibiotics for the mother: More antibiotics for the mother: anaphylaxis, changes in bacterial flora, anaphylaxis, changes in bacterial flora, emergence of resistant strainsemergence of resistant strains

Further disruption of what would have been Further disruption of what would have been normal labor- -IV, early admission to normal labor- -IV, early admission to hospital, induction/augmentation if NIL and hospital, induction/augmentation if NIL and the cascade of interventions including CSthe cascade of interventions including CS

GBS!!!!!!!!!!!GBS!!!!!!!!!!! Left sided thinking!Left sided thinking! Pediatricians and infectious Pediatricians and infectious

disease specialists worry about disease specialists worry about the babythe baby

Fair enough, but what about the Fair enough, but what about the mother?mother?

Right side is collateral damage to Right side is collateral damage to the motherthe mother

The The precautionary principle precautionary principle of non-of non-maleficence (first do no harm), maleficence (first do no harm), requires that potentially harmful requires that potentially harmful actions or routines in the actions or routines in the “management” of vaginal birth be “management” of vaginal birth be eliminated before recommending a eliminated before recommending a potentially harmful intrusion like potentially harmful intrusion like routine epidural analgesia or routine epidural analgesia or Cesarean on demand.Cesarean on demand.

Examples of such practices:Examples of such practices: undermining women’s capacity to give birth with undermining women’s capacity to give birth with

as little intervention as possibleas little intervention as possible failure to utilize non-pharmacological failure to utilize non-pharmacological

approaches to pain management firstapproaches to pain management first unsupported labor (think doulas)unsupported labor (think doulas) unphysiological positions and purple pushingunphysiological positions and purple pushing routine episiotomyroutine episiotomy

All of which lead to complications that make All of which lead to complications that make women feel incapable of giving birth without women feel incapable of giving birth without massive intervention and promote requests for massive intervention and promote requests for early epidurals and even Cxion on demandearly epidurals and even Cxion on demand

The EndThe End