healthy mothers and healthy babies

February 21 - 22, 2014 | Vancouver, BC

Healthy Mothersand Healthy Babies: New Research and Best Practice Conference

S Y L L A B U S

Healthy Mothers and Healthy Babies: New Research and Best Practice Conference 11

P L E N A R Y

Plenary The Intergenerational Cycle of Obesity – Why We Should Be Concerned Kristi Adamo

10/02/2014

1

e H e a l t h S t r a t e g y O f f i c e

eHealth Enabled mother & baby centred care: trends and opportunities

Healthy Mothers & Healthy Babies ConferenceFebruary 21st, 2014

Kendall Ho, MD FRCPCProfessor, Emergency Medicine

Director, eHealth Strategy Office


•

•

•

•

•


AliveCor MobisanteUltrasound

Probes

NetraiExaminer

Medtronic CGM

SpiroSmart (FEV1, FVC, PEF)

From telehealth to mHealth

AirStrip Patient Monitoring

From Pt Centred Care to Active Pt Engagement

86 February 21 - 22, 2014 | Vancouver, BC

P L E N A R Y

Plenary eHealth Enabled Mother and Baby Centred Care: Trends and Opportunities Kendall Ho

10/02/2014

2

(Reuters February 3, 2010)

2010 Survey (Oct-Nov 2010, 22,600) •8/10 Canadians (>16) Internet for personal use•1/3 go on line via mobile devices•64/100 for medical information

A set of socio-technical approaches for people to connect, support, and learn from each other


• Content (documentation)

• Comfort (sharing)

• Communication (network)

• Consideration (reflection)

SMS/Text Messaging in Health• Lifestyle management (exercise, weight, …)• Smoking cessation• Drugs of abuse cessation• Medical results reporting• Medication reminder• Diabetes• Asthma• Sexually transmitted infections• ….


• Mental wellness

• Diet

• Exercise

• Physiology

• …

Mobile Health Apps: “43,000+”

“Fav Apps” criteria:

• Usefulness

• Ease of use

• Safe

• Cost: “free” preferable

• Privacy


P L E N A R Y

10/02/2014

3

Mood Panda

Mindshift

• Test Anxiety• Perfectionism• Social Anxiety• Performance Anxiety

• Worry• Panic• Conflict




P L E N A R Y

10/02/2014

4



Biosensors Text Messaging

Social Media

Mobile Digital Access to Wireless Network (mDAWN)

Diabetic patients & caregivers

Mobile Platform for Children & Mother

Guangzhou & Vancouver


•

•

•

•

•

•

•

•

•

•

•

•



Web: www.eHealth.ubc.caFacebook: UBC eHealth Strategy OfficeTwitter: @ehealthstrategy


P L E N A R Y

14-‐01-‐28

1

D R . D E A N L E D U C M O N T F O R T H O S P I T A L

F E B R U A R Y 2 2 , 2 0 1 4 V A N C O U V E R , B C

Induction of Labor Provocation de travail

I H A V E N O F I N A N C I A L R E L A T I O N S H I P S T O D I S C L O S E

I W I L L D I S C U S S O F F - L A B E L U S E O F M I S O P R O S T O L

I W I L L N O T D I S C U S S I N V E S T I G A T I O N A L P R O D U C T S

Induction of Labor

Induction of Labor

 Objectives ¡ Review SOGC IOL guideline

 Importance cervical status  Selection method to optimize VD  Prevention of induction  Choices of induction agent

¡ Literature since publication

Induction rates, 1995-2005

Induction rates, 2007-2012

BORN Ontario

Induction rate by region in Ontario

BORN, 2011-12


P L E N A R Y

Plenary Induction of Labour Dean Leduc

14-‐01-‐28

2

Induction of Labor, Workload

Induction of labor represent 25-33% of our intra-partum workload

Indications – High Priority

  Pre-eclampsia > 37 weeks*   Term PROM / GBS positive   Chorioamnionitis   Suspected fetal compromise   Stable antepartum hemorrhage   Significant maternal disease

*change in the 2013 SOGC guidelines

Indications – Other

  Post dates (>41 weeks)   Post-term (> 42 weeks)   Oligohydramnios   IUGR   Gestational HTN > 38 weeks*   Term PROM / GBS negative   Twin >= 38 weeks   Intrauterine fetal demise (IUFD)/prior IUFD   Diabetes (not controlled)*   Logistical (precipitous labor, distance)

Indications - unacceptable

  Suspected fetal macros0mia in non-diabetic women*   Patient / care provider convenience

Complications of IOL

  Failure to achieve labor / delivery   CS   Operative vaginal delivery   Tachysystole ± fetal changes   Chorioamnionitis   Cord prolapse with ARM   Uterine rupture

Contra-indications

Contra-indications to vaginal delivery


P L E N A R Y

14-‐01-‐28

3

Induction of Labor

HOW DOES CERVICAL STATUS HELP ME?

Cervical factors and successful induction

Bishop > 6 CS rate same as spontaneous labor Resources

Neilsen 2005, Durodola 2005, Osmundson 2010

Cervical factors and prediction of success

Cervical dilation >

Effacement, station, position >

Consistency

Crane, 2006

Failed induction

Xenakis, 1997

Failed induction defined as inability to achieve active phase of labor > 4cm despite adequate exposure to cervical priming and oxytocin stimulation (high dose protocol)

Failed induction / CS rate

Xenakis, 1997

Induction of Labor

WHAT ABOUT OTHER CLINICAL FACTORS FOR SUCCESS?


P L E N A R Y

14-‐01-‐28

4

Risk factors associated with IOL success

Factor

OR

Multiparity 4.63

Bishop score > 4 2.2

BMI > 30 0.6

Age > 35 0.79

Pevnver, 2009

Risk factors associated with IOL failure

Vrounraets, 2005

Ennen, 2005 Erhnedal, 2010

OR OR OR

Nulliparity 3.85

Bishop score 2.3 (BS<5) 2.4 (BS <1)

BMI 2.87 (>30) 1.9 (>40) 4.3 (>30) / 6.3 (>40)

Diabetes 1.9 1.8

Age 1.6 (>30) 2.4 (>35)

2.0 (>25)

Pre-induction factors – Risk for failure

  Unfavorable cervix (Bishop ≤6)   Obesity (BMI > 40)

¡  Ennen, Pevnver, Ehrendal

  Estimated fetal weight > 4000gm ¡  Ennen, Coonrod

  Diabetes mellitus, pre-existing ¡  Ennen, Coonrod

  Maternal age > 35 ¡  Pevnver, Ehrendal, Coonrod

What about other methods cervical assessment?

  Fetal fibronectin + TVUS

  Shown to predict successful induction

  Neither superior to Bishop score

Crane, 2006

Reasons for Induction

BORN, 2011-12

Induction of Labor

POST- DATES


P L E N A R Y

14-‐01-‐28

5

Routine vs Indicated Induction of Labour at 41 or > 41 weeks GA

Gulmezoglu AM et al, Cochrane Library Issue 6, 2012

Perinatal death(>41) 0.31 (0.12,0.88)

MAS (41) 0.27 (0.11,0.68)

C/S (41) 0.74 (0.58,0.96) C/S (>41) 0.91 (0.82,1.00)

Assisted Vag Del (41) 1.09 (0.40,2.98)

Assisted Vag Del (>41) 1.05 (0.65,1.16)

Apgar<7 at 5 min (41) 0.55 (0.12,2.55)

0.1 1 10 Relative Risk (95% Confidence Interval)

Outcome RR

MAS (>41) 0.61 (0.40,0.92)

Apgar<7 at 5 min (>41) 0.75 (0.44,1.26)

NNT=410

Induction of Labor

HOW DID THIS ALL START?

Hannah Trial

  IOL vs serial monitoring in post term pregnancy   3407 women   > 41 weeks, uncomplicated, singleton, vertex pregnancy,

cx < 3cm   RCT at >= 41 weeks

¡  Induction within 2-3 days (study group) vs monitored (control group)

¡  Serial monitoring – Kick count and AFV + NST 2-3 per week   Induced if NST abnormal, low AFV (< 3cm), OBS complication, 44

weeks

  Outcomes ¡  Rate of CS ¡  Perinatal mortality and neonatal morbidity

NEJM, 1992

Hannah Trial

Induction group

Serial monitor group

P value

Numbers 1701 1706

Method induction

PG x 3, oxytocin/ARM

Oxytocin/ ARM / CS

CS 360 (21.1%) 418 (24.5%) 0.03

CS fetal distress 5.7% 8.3% 0.003

Perinatal deaths 2 0* NS

•  2 infants with lethal congenital abnormalities excluded •  1 death – IUFD, presence of meconium, , HIE •  1 death – labor, acute fetal distress, NRP, meconium aspiration

Hannah Trial (NEJM, 1992)

  Conclusion ¡  Lower rate of CS in induction group ¡  Similar perinatal mortality and neonatal morbidity

  Resulted in the routine offer of induction > 41 weeks

SOGC Guidelines

  Management of Post Term Pregnancy, 1994 ¡  Patient should be offered elective delivery. ¡  Labor should be induced or CS in the case that a VD is

contraindicated

  Post-term Pregnancy, 1997 ¡  A policy of induction for women who reach 41 weeks is

preferred due to higher risk of adverse maternal, fetal and neonatal outcomes.

  Induction of Labor at Term, 2001 ¡  Indication should be discussed ¡  Ripening of the cervix should be considered before induction

  Induction of Labor, 2013


P L E N A R Y

14-‐01-‐28

6

Induction of Labor

PREVENTION OF POST-DATES

Prevention of post dates (>41 weeks)

  Accurate dating ¡  LMP ¡  1st trimester US +/- 5 days ¡  2nd trimester US +/- 10 days

  Sweeping membranes – 3 circumferential rotations within the cervix or massage for 15-30 sec ¡  Weekly after 38 weeks (Yildirm, 2009)

 NNT (to prevent one induction) = 8 ¡  Twice weekly after 41 weeks (de Miranda, 2006)

 NNT (to prevent one induction) = 6

  Intercourse ¡  No difference (Tan, 2007)

Women < 41 weeks induced for post dates

BORN, 2011-12

Prevention of post dates (>41 weeks)

  Quality improvement program ¡  Induction committee used to review each request for induction

request and enforce the use of proper indication  Fisch, 2009 – reduction elective inductions < 39 weeks  Oshiro, 2009 - reduction elective inductions < 39 weeks  Reisner, 2008 - reduction elective inductions < 39 weeks and

unfavorable cervix ¡  Decrease CS rate for all institutions

  Institutional philosophy ¡  Low induction centers had a lower overall CS rate compered to

higher induction centers

Methods of induction

  Mechanical - Foley   Prostaglandins

¡  PGE2 – dinoprostone ¡  PGE1 - misoprostol

  ARM   Oxytocin   Breast stimulation

Mechanical

  Catheter   Contra-indications

¡  Absolute – low lying placenta ¡  Relative – APH, ruptured membranes, infection

  Advantages ¡  Less tachysystole ¡  Can be used as an outpatient ¡  VBAC ¡  No increase rates maternal / neonatal infection ¡  No increase risk CS compared to PG

  Disadvantages ¡  Increase need for oxytocin


P L E N A R Y

14-‐01-‐28

7

PROBAAT studies (Prostaglandin versus balloon for IOL)

  Foley (30ml ) vs: ¡  Prostaglandin E2 gel (PROBAAT), 2011 ¡  Prostaglandin 10mcg vaginal insert (PROBAAT-P), 2013 ¡  Misoprostol 25mcg vaginal tablet (PROBAAT-M), 2013

  Prospective, RCT, not blinded   Single, term, cephalic, intact membranes, unfavorable

cervix (Bishop <6), no prior CS   ARM when favorable, oxytocin augmentation prn   Outcomes

¡  Primary – CS ¡  Secondary – maternal and neonatal morbidity

  Included meta-analyses in their results Eikhelder, 2013

PROBAAT (Foley vs PGE2 gel)

  824 women, 412 Foley, 412 vaginal PGE2 gel   Results:

¡  Similar rate of CS (23% vs 20%) ¡  Similar rate of fetal distress (7% vs 9%) ¡  More oxytocin augmentation with Foley group (86% vs 59%,

p<0.001) ¡  Similar hyperstimulation rates (2% vs 3%) ¡  All cases of hyperstimulation with Foley had oxytocin ¡  Longer intervention-delivery time similar with Foley (29h vs

17h, p<0.001)

Jozwiak, 2011

PROBAAT-P (Foley vs PGE2 pessary)

  226 women, 107 Foley, 119 vaginal inserts   Results:

¡  Similar rate of CS (20% vs 22%) ¡  Similar rate of fetal distress ¡  Less hyperstimulation with Foley alone but similar when

oxytocin used ¡  Intervention-delivery time similar (28h vs 27h)

Jozwiak, 2013

PROBAAT-M (Foley vs PGE1)

  120 women, 56 Foley, 64 misoprostol   Results:

¡  Non-significant difference in rate of CS (25% Foley vs 17% miso, RR 1.46 95% CI 0.72-2.94)

¡  More CS due to dystocia in Foley group (14% vs 3%) ¡  No difference in hyperstimulation ¡  Intervention-delivery time longer in Foley group (36h vs 25h,

p<0.001)

Jozwiak , 2013

Outpatient vs Inpatient Foley

  RCT outpatient (61 women) vs inpatient (50 women) Foley for IOL unfavourable cervix

  Results: ¡  Similar change in Bishop score ¡  No difference in oxytocin, epidural rate, induction time, Apgar

and cord pH ¡  Less hospitalization time for outpatient group

Sciscione, Obstet Gynecol, 2001

Outpatient Foley vs Inpatient PGE2

  RCT outpatient Foley (50 women) vs inpatient vaginal PGE2 (51 women) for IOL unfavourable cervix

  Results: ¡  OPC had shorter antenatal hospital stay (21.3h vs 32.4h) ¡  Similar VDs (66% vs 71%), induction-delivery time (33.5h vs

31.3h), total hospital inpatient time (96h vs 105h) ¡  OPC had less pain (26% vs 58%), more sleep (5.8h vs 3.4h) and

more need for oxytocin (88% vs 59%) ¡  IP more likely to deliver within 12h (53% vs 28%)

Henry, BMC Preganancy and Childbirth, 2013


P L E N A R Y

14-‐01-‐28

8

Mechanical – Single vs double lumen

  RCT, 330 women, > 36 weeks, nulliparous, BS<5

Single lumen

Double lumen

PGE2 P score

CS 36% 43% 37% NS

Induction to delivery time

25.8h 30.6h 25.8h P=0.043

Tachysystole None None 14% P=0.050

Pain score >3 36% 55% 63% P< 0.001

Foley had lower CS rate, lower induction-delivery time and less pain

Pennell, BJOG 2009

Maternal / neonatal infection – Foley vs PG

  Systematic review, 30 RCTs

Outcomes Foley Pharmaco-logical

Pooled OR (95% CI)

Maternal infection

7.6% 5.0% 1.5 (1.07-2.09) é

Chorioamnionitis 7.6% 3.7% 2.05 (1.22-3.44) é

Endometritis 5.1% 3.2% 1.47 (0.74-1.94) è

Neonatal infection

3.2% 2.5% 1.2 (0.48 – 2.97) è

Higher rate for all mechanical but rates similar for studies limited to Foley catheters. Heinemann, AJOG, 2008

Mechanical - summary

  Safe   Outpatient   Unfavourable cervix   VBAC   More need for oxytocin

Prostaglandins

  Prostaglandin E2 – dinoprostone ¡  Intracervical gel - Cervidil® ¡  Intravaginal gel - Prostin® ¡  Intravaginal pessary - Prepidil®

  Prostaglandin E1 – misoprostol ¡  Oral ¡  Vaginal

Prostaglandin E2 – Intact Membranes

  Kelly, Cochrane, 2009   63 studies, 10 441 women, intact membranes   No difference CS

PG placebo

No SVD 24h 18% 99% ê

Oxytocin stimulation

21.6% 40.3% ê

Tachysystole 4.6% 0.51% é

Prostaglandins work with intact membranes

Prostaglandin E2 - PROM

  Dare, Cochrane, 2006   12 trials, 6814 women, PROM > 37 weeks

Outcomes Relative risk

CS 0.94 (0.82-1.08) è

Operative VD 0.98 (0.84-1.16) è

Chorioamnionitis 0.74 (0.56-0.97) ê

Endometritis 0.3 (0.12-0.74) ê

Neonatal infection 0.83 (0.61-1.12) è

NICU 0.72 (0.57-0.92) ê

Negative experience 0.45 (0.37-0.54) ê

Prostaglandins work with ruptured membranes


P L E N A R Y

14-‐01-‐28

9

Sweeping + PGE2

  Foong, 2000, RCT 130 nullip + 118 multip, term ¡  Benefits limited to nullips with unfavourable cervix

 Shorter induction labor time (13.6h vs 17.3h)   Increase vaginal delivery (83.3% vs 58.2%)

  Tan, 2006, RCT, 264 women, term ¡  Benefits to nullip and multips

 Higher SVD (69% vs 56%)  Shorter induction-labor time (14h vs 19h)  Less oxytocin (46% vs 59%)  More post-sweeping pain

Prostaglandins work better when sweeping is performed at the time of insertion

Time of day

  Dodd, 2006, Obstet Gynecol   RCT, 620 women, > 37 weeks, PG induction Time of admission

0800h 2000h RR

Oxytocin infusion

45% (126/280)

54% (184/340)

0.83 (0.7-0.97) ê

Operative vaginal delivery (nullip only)

16.1% (10/62) 34.2% (28/82)

0.47 (0.25-0.90) ê

No difference primary outcomes – vaginal delivery < 24h, CS, tachysystole with FH changes Less intervention when started in morning

Outpatient Induction with vaginal PGE2

  Biem, JOGC, 2003   300 women, > 37 weeks, reactive NST, Bishop <7

Outcome Outpatient (n=150)

Inpatient (n=150)

P value

Satisfaction 56% 39% < 0.008 Delivery < 24h 115 107 NS Time to labor 9.8h 11.4h NS

Time to delivery 21.4h 20.7h NS Oxytocin 22 29 NS CS 35 37 NS Epidural 117 115 NS Tachysystole 15 15 NS Non-reassuring FH 4 1 NS

Induction of Labor

How many doses of PGE2 can I give?

Methods for repetitive doses PGE2

  Retrospective cohort 3514 nulliparous induced for post-dates   Bishop < 6   Compared <2 and > 2 (max 5) doses PGE2 tabs/gel

¡  PGE2 licensed for 2 doses only   Maternal and neonatal outcomes

¡  Mode of delivery – CS, SVD, AVD ¡  Indication for CS – failed IOL, dystocia ¡  Oxytocin stimulation ¡  Epidural ¡  PPH ¡  Terbutaline use for “hyperstimulation” ¡  NICU admission ¡  Apgar < 7 at 5 minutes

Ayaz, Eur J Obstet Gynecol, 2013

Results for repetitive doses PGE2

Maternal outcomes



P L E N A R Y

14-‐01-‐28

10


Neonatal outcomes





  Conclusion by authors: ¡  No increased maternal or neonatal morbidity

  Increased number of doses of PGE2: ¡  Increase CS ¡  Increased failed IOL (cervix not favorable to perform ARM) ¡  Increase dystocia ¡  Decrease SVD

Induction of Labor

Is PGE2 safe in grand-multiparous women?

PGE2 safety in grand-multiparous women

  Retrospective study of 1376 women, parity > 5   VD 96.6% of women   No difference in:

¡  CS ¡  Operative vaginal delivery ¡  PPH (all received 20U oxytocin im/iv + 0.2mg ergot) ¡  One case of uterine rupture (one day after perforated

appendix)

Haas, Journal Maternal-Fetal and Neonatal Medicine, 2013; 26

PGE2 – Summary

  Bishop < 7 (unfavorable cervix)   PGE2 are effective agents of cervical ripening   Safe with ruptured membranes at term   Safe in asthma   Outpatient for low risk women   Cannot be used in VBAC (contrary to NICE 2008

guidelines)   Sweep + insertion   Less intervention when applied in the morning


P L E N A R Y

14-‐01-‐28

11

Induction of Labor

WHAT ABOUT MISOPROSTOL?

Prostaglandin E1 - misoprostol

  Cervical ripening agent + uterotonic   Approved for prevention and treatment of gastric

ulcers   First study published 1987 to describe successful

induction of labor of stillbirth   > 100 RCTs for obstetrical care   Inexpensive, stability at room temperature, rapid

onset

Misoprostol vs placebo / PGE2

  Hofmeyr, 2010   Cochrane review, 121 trials

¡  Compared to placebo  Less failure to achieve vaginal delivery < 24h (RR 0.51)  More tachysystole

¡  Compared to PGE2 / oxytocin  Less epidural use  Less failure to achieve vaginal delivery < 24h  Less oxytocin augmentation  More meconium stained liquor  More tachysystole

Misoprostol vs Dinoprostone

  Multiple reviews (Cochrane, 2006; Crane, 2006; Kundodyiwa, 2009; Cochrane 2010) ¡  Lower CS ¡  More tachysystole ¡  Similar or less need for oxytocin ¡  Trend more meconium ¡  Less failure to achieve vaginal delivery < 24 hours ¡  No increase maternal / fetal adverse events

Misoprostol – Oral vs Vaginal

  Cochrane review (Alfiveric, 2006) found that oral had: ¡  Less tachysystole without FH changes (RR 0.37) ¡  More need for oxytocin (RR 1.28) ¡  More meconium (RR 1.27)

  RCT 204 women (Colon, 2005) – 25mcg PO vs 50mcg PV ¡  Less tachysystole with FH changes (2.2% vs 5.4%) ¡  Lower CS rate (19.4% vs 32.4%) ¡  No difference induction-delivery time or side effects (fever, shivering,

nausea)

  RCT 120 women (Cecatti, 2006) – 12.5mcg PO vs 25mcg PV ¡  No difference mode of delivery, induction-delivery time, oxytocin use

Misoprostol – Dosing

  Vaginal – 25mcg vs 50 mcg ¡  More need for oxytocin ¡  Less tachysystole ± fetal heart rate changes ¡  Longer induction – delivery time ¡  More use oxytocin ¡  Less vaginal deliveries < 24h

  Oral – 25mcg/50mcg vs placebo ¡  Less prolonged labor ¡  Less need oxytocin ¡  Lower CS rate


P L E N A R Y

14-‐01-‐28

12

Misoprostol – Dosing

  Vaginal – 25mcg every 4 hours   Oral – 50mcg every 4 hours / 25mcg every 2 hours

  Oxytocin – can be used 4 hours after the last dose

Misoprostol vs Foley

  Adenji (2005) ¡  RCT, 96 women, 50mcg vaginal vs Foley

 Reached favorable cervix (Bishop ≥ 6) faster  Lower use oxytocin  Same induction-delivery time

  Afolabi (2005) ¡  RCT, 100 women, 100mcg vaginal vs Foley

 Shorter induction-delivery time

Misoprostol / Term PROM

  Krupa (2005) – open RCT, 150 women   25mcg vaginal vs expectant ± oxytocin management

¡  Shorter latency period ¡  Shorter recruitment time to delivery ¡  Trends

 Lower oxytocin use  Lower CS

Study stopped due to lack of funding More studies required

Misoprostol - summary

  Safe and effective agent for induction   Reduce CS rate in unfavourable cervix   Intact membranes only (further studies needed)   Not for out-patient use or VBAC   Dose

¡  50mcg oral every 4 hours ¡  25mcg vaginally every 4 hours

  EFM same as PGE2 ¡  30 minutes after administration ¡  60 minutes after any tachysystole

  Oxytocin 4 hours after the last dose   All doses/routes cause more tachysystole   Oral route needs more oxytocin but has less tachysystole than

vaginal route

Amniotomy

  No studies comparing amniotomy to placebo   Used when the cervix is favourable   Cochrane 2007 (Howarth)

¡  ARM + oxytocin had more vaginal deliveries < 24h than ARM alone

¡  ARM + oxytocin had less operative vaginal deliveries than placebo

¡  ARM + oxytocin had more PPH and maternal dissatisfaction than vaginal PGs

Oxytocin

  Cochrane 2009 (Alfiveric)   Oxytocin vs PG for cervical ripening

¡  Increase un-successful vaginal delivery < 24h (70% vs 21%) ¡  Fewer vaginal deliveries (51% vs 35%) ¡  Increase CS (19.1% vs 13.7%), regardless of membrane status


P L E N A R Y

14-‐01-‐28

13

Oxytocin

Low dose vs high dose? How high? How fast?

Oxytocin – High vs Low

Studies showing benefit of oxytocin have used one or the other No studies of comparing one dosing regimens Regional variation / local expertise

How much can the fetus tolerate?

Induction of Labor – other agents

Other agents without proven benefit:   Castor oil (Kelly, Cochrane 2009– nausea, no benefit   Breast stimulation (Kavanagh, Cochrane 2009 –

more women in labor at 72 hours compared to no treatment

  Acupuncture (Smith, Cochrane 2009)– no data   Homeopathic medications (Cochrane 2010)– not

enough evidence

WHAT ABOUT TERM PROM?

TERM PROM Study

Oxytocin PG

Induction 1258

Expectant 1263

P value Induction 1259

Expectant 1261

P value

Nothing they disliked

74 (5.9%)

17 (13.7%)

<0.001

64 (5.1%)

124 (11.7%)

<0.001

Would repeat in the study

847 (67.3%)

756 (59.9%)

<0.001

837 (66.5%)

746 (59.2%)

<0.001

Women preference – induction vs expectant/ oxytocin and PG

Conclusion – women preferred induction with oxytocin or PG vs expectant Hannah, NEJM, 1996

WHAT ABOUT TERM PROM +GBS?


P L E N A R Y

14-‐01-‐28

14

TERM PROM Study

  5041 women   GBS culture at time of PROM (no universal

screening)   IV oxytocin vs PGE2 gel q 6h   Less GBS disease in oxytocin induction group than

PGE2 induction + either expectant group   Inadequate prophylaxis for both groups

¡  23% induction group and 28% in expectant (4 days later) group

Hannah, AJOG, 1997

WHAT ABOUT PPROM?

Misoprostol / PROM > 34 weeks

  Bricker (2007)   RCT 758 women   2 groups compared to vaginal dinoprostone ± oxytocin

¡  Bishop > 6 –> 25 mcg oral vs oxytocin ¡  Bishop ≤ 6 -> 50 mcg vaginal vs dinoprostone ± oxytocin

  Terminated early due to lack of funding (needed 1890 women)   No difference CS or vaginal delivery rates   Trends in misoprostol group

¡  Less use of oxytocin ¡  Less epidural use ¡  Less CS for dystocia ¡  More effective than dinoprostone in the setting of an unfavourable cervix ¡  Less effective than oxytocin in the setting of favourable cervix

More studies required

Induction of Labor- Promexil 1

  RCT PPROM 34-37 weeks   IOL (n=266) vs expectant management (n=266)

¡  IOL within 24 hours (oxytocin or PGE2) ¡  EM group induced at 37 weeks IOL (n=266) EM (n=266) RR

Neonatal sepsis 7 (2.6%) 11 (4.1%) 0.64 (0.25-1.6)

RDS 21 (7.8%) 17 (6.3%) 1.3 (0.67-2.3)

CS 36 (13%) 37 (14%) 0.98 (0.64-1.65)

Chorioamnionitis 6 (2.3%) 15 (5.6%) 0.4 (0.16-1.02)

Histological chorio 43 (22%) 62 (32%) 0.69 (0.49-0.96)

VanDerHam, Promexil 1, Plos Med, 2012

Induction of Labor- Promexil 2

  RCT PPROM 34-37 weeks   IOL (n=100) vs expectant management (n=95)

¡  IOL within 24 hours (oxytocin or PGE2) ¡  EM group induced at 37 weeks IOL (n=100) EM (n=95) RR

Neonatal sepsis 3 (3%) 4 (4.1%) 0.07 (0.17-3.2)

RDS 6 (6%) 5 (5.1%) 1.2 (0.37-3.7)

Chorioamnionitis 0 4 (4.3%

Histological chorioamnionitis

12 (18%) 18 (31%) 0.64 (0.33-1.2)

VanDerHam, Promexil 2, AJOG, 2012

Summary

  Prevention – dating, sweeping, enforcement, philosophy

  Indication / likelihood of success / failure   Delay induction unfavorable cervix (> 41+2 weeks)   Misoprostol safe for term + intact membranes   Avoid oxytocin for an unfavourable cervix   PGE2 safe for ruptured membranes at term   Outpatient induction with PGE2 and Foley   Add oxytocin sooner rather than later after ARM   VBAC – Foley ± oxytocin


P L E N A R Y

14-‐01-‐28

15

Term – unfavourable cervix

Preferred Acceptable Contra-indicated

Mechanical Amniotomy PGE2 and PGE1 VBAC

PGE2

Oxytocin (high presentation with risk of prolapse)

PGE1 (oral=vaginal)

Intact membranes


PGE2 (GBS -) Oxytocin PGE1

Oxytocin (GBS+) PGE2 (GBS+) ?

Mechanical

Ruptured membranes

Term – Favourable cervix


Amniotomy =/- oxytocin Oxytocin (high presentation with risk of prolapse)

PGE2 and PGE1 VBAC

PGE2

PGE1 (oral=vaginal)

Intact membranes


Oxytocin PGE2 (GBS+) ? PGE1

Ruptured membranes

REFERENCES

Leduc, Berringer, Lee, Dy : Induction of Labor, SOGC, Clinical Practice Guidelines, JOGC, September 2013 Health Canada, CIHI BORN (Better Outcomes Registry and Network) Database GülmezogluAM,CrowtherCA,MiddletonP,HeatleyE.Inductionoflabourforimprovingbirthoutcomesforwomenator beyond term. Cochrane Database of Systematic Reviews 2012, Issue 6. Eikelder et al; Induction of Labor with a Foley catheter or oral misoprostol: the PROBAAT-II study, a multicenter randomised controlled trial; BMC Preg and Childbirth, 2013, 13:67 Jozwiak et al; Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial, Lancet2011;378:2095–103 Jozwiak et al, Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature European J Obstet & Gynecol and Reproductive Biology 170 (2013) 137–145 Jozwiak et al, Foley Catheter versus Vaginal Misoprostol: Randomized Controlled Trial (PROBAAT-M Study) and Systematic Review and Meta-Analysis of Literature, AJOG, 2013 Henry et al, Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial, BMC Pregnancy and Childbirth 2013, 13:25 Ayaz, Maternal and neonatal outcomes following additional doses of vaginal prostaglandin E2 for induction of labour: a retrospective cohort study, European Journal of Obstetrics & Gynecology and Reproductive Biology 170 (2013) 364–367 Haas, Safety of labor induction with prostaglandin E2 in grandmultiparous women, The Journal of Maternal-Fetal and Neonatal Medicine, 2013; 26(1): 49–51

REFERENCES

VanderHam, Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial), BMC Pregnancy and Childbirth 2007, 7:11 Van der Ham DP, Vijgen SMC, Nijhuis JG, van Beek JJ, Opmeer BC, et al. (2012) Induction of Labor versus Expectant Management in Women with Preterm Prelabor Rupture of Membranes between 34 and 37 Weeks: A Randomized Controlled Trial. PLoS Med 9(4) van der Ham DP, van der Heyden JL, Opmeer BC, et al. Management of late-preterm premature rupture of membranes: the PPROMEXIL-2 trial. Am J Obstet Gynecol 2012;207:276.e1-10. All other references can be found in the 2013 SOGC Induction of labor Guidelines


P L E N A R Y


P L E N A R Y

Plenary Classifying Caesarean Section Rates and Perinatal Outcome Michael Robson

Classification systems in medicine Classification systems are needed in medicine to organise crude data and information into useful information so that clinical care can be improved. Each classification system in medicine has its own purpose. They are based on the identification of different concepts that may each have several parameters. Different permutations of these parameters and their systematic arrangement result in specific groups or categories that share some defined property feature or quality. Principles of classification systems The purpose of the classification system determines the structure of the classification. The main groups of the classification need to be robust enough to be unlikely to need changes over time and universal in nature so it can be used anywhere in the world with minimal resource . The groups or categories of the classification need to be prospectively identifiable so that outcome can be improved in those same patients in the future. The groups or categories must be mutually exclusive, totally inclusive and clinically relevant. The classification system must be simple to understand and easy to implement. Ideally the classification should be self validating as well so that potential discrepancies can be spotted by merely looking at the table. Classification systems can only be useful if the data or information being collected and analysed by the classification system fulfils the principles of information collection. The information needs to be useful, it needs to be carefully defined, it needs to be accurately collected, and it needs to be timely and available1. The last requirement will be the discipline of the users, who only by sticking to a standard system will ensure the system’s success. Current classification systems used for caesarean sections and perinatal outcome There is no accepted classification system2,3. There have been many descriptive studies but no classification system, which fit the principles, described above and has been used to make changes in specific prospective groups of women. Caesarean section rates have been analysed by comparing overall rates, by indication for caesarean section, by sub-‐groups of women and by primary and repeat caesarean section rates. They all have their disadvantages4. The ten group classification of caesarean sections The purpose of this classification5 was by using the principles described above to make possible comparisons of all maternal and fetal outcomes and variables of which caesarean section rate is but one, over time in one unit and between different units6,7,8,9,10,11,12. This would then allow the possibility of reducing the caesarean section rate13,14,15. The obstetric concepts, with their parameters, used to group and categorise the women were the category of the pregnancy, the previous obstetric record of the woman, the course of labour and delivery and the gestational age of the pregnancy. From these concepts and their parameters 10 groups were formed. The indications for Caesarean section should be specifically defined within each group of women because the definition and the management may vary in each group. The classification in Table 1 is a recommended method for classifying Caesarean sections, which fit the above requirements. It is being successfully used. Each of the 10 groups can be further subdivided when indicated. There are four suggested ways of analysing the initial data. In the first column the number of caesarean sections in each group is shown over the total number of women in that group. In the second group the relative sizes of the groups are shown. In the third column the caesarean section rate in each group is shown. Lastly in the fourth column the relative contribution of each group to the total caesarean section rate is shown.


P L E N A R Y

Conclusion We need a standard, simple, acceptable classification of caesarean section rates and other perinatal outcome that will help us to learn more about the reasons why there are differences in rates over time, and between units, both nationally and internationally. The question that should be answered in the future is not whether a caesarean section rate is too high or too low, but rather what is it, is it appropriate and are there other consequences.

Groups

Overall Caesarean Section (CS) Rate (%) 2023/9756 (20.7%)

The National Maternity Hospital 2010 Ireland

Number of CS over total number of

women in each group

Relative size of

groups %

CS rate in each

group %

Contribution made by each group to the overall CS rate %

1. Nulliparous, single cephalic, ≥ 37 weeks, in spontaneous labour

202/2685 27.5 (2685/9756)

7.5 (202/2685)

2.1 (202/9756)

2. Nulliparous, single cephalic, ≥ 37 weeks, induced or CS before labour

508/1472 15.1 (1472/9756)

34.5 (508/1472)

5.2 (508/9756)

3. Multiparous (excluding prev. CS), single cephalic, ≥ 37 weeks, in spontaneous labour

35/2801 28.7 (2801/9756)

1.3 (35/2801)

0.4 (35/9756)

4. Multiparous (excluding prev. CS), single cephalic, ≥ 37 weeks, induced or CS before labour

112/908 9.3 (908/9756)

12.3 (112/908)

1.1 (112/9756)

5. Previous CS, single cephalic, ≥ 37 weeks 560/926 9.5 (926/9756)

60.5 (560/926)

5.7 (560/9756)

6. All nulliparous breeches 194/204 2.1 (204/9756)

95.1 (194/204)

2.0 (194/9756)

7. All multiparous breeches (including prev. CS) 106/130 1.3 (130/8756)

81.5 (106/130)

1.1 (106/9756)

8. All multiple pregnancies (including prev. CS) 135/204 2.1 (204/9756)

66.2 (135/204)

1.4 (135/9756)

9. All abnormal lies (including prev. CS) 28/28 0.3 (28/9756)

100 (28/28)

0.3 (28/9756)

10. All single cephalic, ≤ 36 weeks (including prev. CS) 143/398 4.1 (398/9756)

35.9 (143/398)

1.4 (143/9756)

Table 1: The 10 Group Classification 1. Robson MS. Labour Ward Audit. In: Management of Labour and Delivery. Ed. R.Creasy, 1997 Blackwell Science pp. 559-‐570. 2. Bragg F, Cromwell DA, Edozien LC, Gurol-‐Urganci I, Mahmood T, Templeton A and Van Der Meulen JH. Variation in rates of caesarean section

among English NHS trusts after accounting for maternal and clinical risk: cross sectional study. BMJ 2010 Vol. 341 (Oct06 1) pp. c5065-‐c5065 3. Knight M and Sullivan EA..Variation in caesarean delivery rates. BMJ 2010 vol. 341 pp. c5255 4. Torloni MR, Betran AP, Souza JP, Widmer M, Allen T, Gulmezoglu M and Merialdi M. Classifications for cesarean section: a systematic review. PLoS

ONE 2011 vol. 6 (1) pp. e14566 5. Robson MS. Classification of Caesarean Sections. Fetal and Maternal Medicine Review 2001; 12:23-‐39. 6. Allen VM, Baskett TF, and O'Connellon CM. Contribution of select maternal groups to temporal trends in rates of caesarean section. J Obstet

Gynaecol Can . 2010 vol. 32 (7) pp. 633-‐41 7. Betrán A, Gulmezoglu A, Robson M, Merialdi M, Souza J, D Wojdyla D, Widmer M, Carroli G, Torloni M, Langer A, Narváez A, Velasco A, Faúndes A,

Acosta A, Valladares E, Romero M, Zavaleta N, Reynoso S and Bataglia V. WHO Global Survey on Maternal and Perinatal Health in Latin America: classifying caesarean sections. Reprod Health 2009 vol. 6 (1) pp. 18

8. Brennan D, Robson M, Murphy M and O'Herlihy C. Comparative analysis of international cesarean delivery rates using 10-‐group classification

identifies significant variation in spontaneous labor. Am J Obstet Gynecol 2009 vol. 201 (3) pp. 308.e1-‐8 9. Howell S, Johnston T and Macleod SL. Trends and determinants of caesarean sections births in Queensland, 1997-‐2006. The Australian & New

Zealand journal of obstetrics & gynaecology 2009 vol. 49 (6) pp. 606-‐11


P L E N A R Y Classification systems in medicine Classification systems are needed in medicine to organise crude data and information into useful information so that clinical care can be improved. Each classification system in medicine has its own purpose. They are based on the identification of different concepts that may each have several parameters. Different permutations of these parameters and their systematic arrangement result in specific groups or categories that share some defined property feature or quality. Principles of classification systems The purpose of the classification system determines the structure of the classification. The main groups of the classification need to be robust enough to be unlikely to need changes over time and universal in nature so it can be used anywhere in the world with minimal resource . The groups or categories of the classification need to be prospectively identifiable so that outcome can be improved in those same patients in the future. The groups or categories must be mutually exclusive, totally inclusive and clinically relevant. The classification system must be simple to understand and easy to implement. Ideally the classification should be self validating as well so that potential discrepancies can be spotted by merely looking at the table. Classification systems can only be useful if the data or information being collected and analysed by the classification system fulfils the principles of information collection. The information needs to be useful, it needs to be carefully defined, it needs to be accurately collected, and it needs to be timely and available1. The last requirement will be the discipline of the users, who only by sticking to a standard system will ensure the system’s success. Current classification systems used for caesarean sections and perinatal outcome There is no accepted classification system2,3. There have been many descriptive studies but no classification system, which fit the principles, described above and has been used to make changes in specific prospective groups of women. Caesarean section rates have been analysed by comparing overall rates, by indication for caesarean section, by sub-‐groups of women and by primary and repeat caesarean section rates. They all have their disadvantages4. The ten group classification of caesarean sections The purpose of this classification5 was by using the principles described above to make possible comparisons of all maternal and fetal outcomes and variables of which caesarean section rate is but one, over time in one unit and between different units6,7,8,9,10,11,12. This would then allow the possibility of reducing the caesarean section rate13,14,15. The obstetric concepts, with their parameters, used to group and categorise the women were the category of the pregnancy, the previous obstetric record of the woman, the course of labour and delivery and the gestational age of the pregnancy. From these concepts and their parameters 10 groups were formed. The indications for Caesarean section should be specifically defined within each group of women because the definition and the management may vary in each group. The classification in Table 1 is a recommended method for classifying Caesarean sections, which fit the above requirements. It is being successfully used. Each of the 10 groups can be further subdivided when indicated. There are four suggested ways of analysing the initial data. In the first column the number of caesarean sections in each group is shown over the total number of women in that group. In the second group the relative sizes of the groups are shown. In the third column the caesarean section rate in each group is shown. Lastly in the fourth column the relative contribution of each group to the total caesarean section rate is shown.

healthy mothers and healthy babies

Documents