Preventing Cesarean Delivery - SIMP · •Manual placental delivery •12:45am Chills; ... CD rates vs Neo Mortality 7-days in 3 Dublin Hospitals ... Pull method? Fasubaa OB, et al.

Preventing Cesarean Delivery

Milano, November 29th, 2014

Vincenzo Berghella, MD

President, SMFM

Professor, Ob-Gyn

Director, MFM Division

Director, MFM Fellowship

Dr Berghella

has nothing to

disclose

Cesarean is common

• 4 million births in US annually

• 32% cesarean = 1.3 million / year

• 130 million births

• >20million cesarean in the world every year

• Most common major surgery

• Last standing approved laparotomy!

OUTLINE

• Why cesarean is necessary – history • Incidence of CD vs Perinatal Morbidity and Mortality

• Strategies for Prevention of 1st CD

•…the initial purpose was essentially to retrieve the infant from a dead or dying mother (Lex Cesarea) •Above all it was a measure of last resort, and the operation was not intended to preserve the mother's life. It was not until the 19th century that such a possibility really came within the grasp of the medical profession.

CESAREAN SECTION -- A BRIEF HISTORY

By Jane Eliot Sewell, Ph.D. for ACOG & NLM

Cesarean delivery: History

The extraction of Asclepius from the abdomen of his mother Coronis by his father Apollo.

Woodcut from the 1549 edition of Alessandro Beneditti's De Re Medica

Slide courtesy of Carolyn Signore

Princess Charlotte of Wales

Nov 3rd, 1817 (Monday)

21y.o, primigravida, 42w 1d

PROM 7pm

‘Obstetricians’ n Sir Richard Croft accoucheur

n Dr John Sims consulting accoucheur

n Dr Matthew Baille Royal Physician

n Sir Everard Home Surgeon to the King

• Officers of State sent for • Archbishop of Canterbury • Bishop of London • Lord Chancellor • Home Secretary • Chancellor of the Exchequer • Secretary of War

• Labor announced through a bulletin

November 4th Tuesday

• Weak contractions q8min, but ‘sharp and distressing’

• 11am ‘Os size of a crown piece’

• 9pm Fully dilated (‘Ear can be felt’)

• 26 hours first stage since SROM

Labor Course

November 5th Wednesday

• 8am Labor slow but favorable

• Instruments in readiness but the employment of them never became a question

• 3pm Head pressed on external parts

• 9pm (24 hrs) Vaginal delivery of boy

• 24 hours 2nd stage

Labor Course

Obstetrics: ‘to stand by’

November 5th Wednesday

9lbs

Green-black

Dead for some hours

Resuscitated for hours

The future king

November 6th Thursday

• Manual placental delivery

• 12:45am Chills; spasms; respiratory difficult

• Pulse rapid, feeble, irregular

• Restless

• 2:30pm Maternal death

Third Stage

Dr Croft committed suicide 3 months later: triple death

24 May 1819

Matthews et al. Rising CD rates: a cause for concern? BJOG 2003

CD rates vs Neo Mortality 7-days in 3 Dublin Hospitals

1979-2000

BEST CESAREAN DELIVERY RATE

5% 95%

No large RCT

Srinivas et al OG 2010 845k PA and CA pts, 401 hosp

*Mat infect, hemorrh; neo death, asphyxia, injury, sz

↓ than expected:

↑ than expected mat/neo compl* ↑ than expected:

Same mat/neo compl*

Jefferson USA

WHO

What is the right CD rate?

• Problems with more CDs

– Intra-operative surgical complications

– Long-term consequences (eg accreta, rupture, etc)

• Risk adjusted

– Robson’s classification: Nullip, term, singleton, vertex

• Ultimate goal

– Lowest maternal morbidity/mortality

– Lowest perinatal morbidity/mortality

Robson. Fet Mat Med Rev 2001

Major focus www.smfm.org

Major Maternal Complications

Infection, hemorrhage, severe lacerations, OR and VTE complications in NY and Florida

Srinivas et al Med Care 2010

Definition of Second Stage Arrest of Labor

History of 2nd stage duration

<1817: no limit (Denman)

1817: 6hrs (Denman, after Charlotte’s death)

1861: 2hrs (Hamilton; ‘ear’, forceps, no IUFD)

1903: 2hrs (Williams 1st ed)

1920: 2hrs (De Lee)

1952: 2hrs (Hellman; pp hemorrhage, mat fever, infant death)

1955/6: 2hrs (Friedman; 95% 2hrs)

Pre:

• CD

• FHR monitoring

• epidural

Prolonged 2nd stage

Parity Epidural Duration

(hrs)

Nulliparous Yes >3

“ No >2

Multiparous Yes >2

“ No >1

Kilpatrick, Laros Obstet Gynecol 1989

ACOG 1989 (Dystocia), 2000 (OVD); RCOG 2000, 2005 (OVD NICE)

Newest, current data

• 95th percentile for nulliparous women

– 2.8 hrs (168 min) without regional anesthesia

– 3.6 hrs (216 min) with regional anesthesia

Zhang et al., for Safe Labor.

Obstet Gynecol 2010

Non-medical factors

• Midwives vs physicians

• Birth center vs Hospital

• Fatigue, workload, anticipated sleep deprivation

• ‘Leisure incentive’: go to sleep or go home

• Salaried, profit-sharing: less CDs

• Legal

Quality and safety: Monitor

• Perinatal Morbidity and Mortality

• Maternal Morbidity and Mortality

• Inductions without indications

• Non-indicated Inductions before 39weeks

• Cesareans without indications

• Failed inductions

• First stage Arrests

• Second Stage Arrests

• NRFHT

CD rate NOT a good

performance indicator

Singh et al JMFNM 2011

[email protected]

• UpToDate

• Gabbe (2012)

New in 8yrs:

73 RCTs

22 meta-analyses

Cesarean Delivery Intra-operative Technique

OUTLINE

• Pre-incision

• Skin to skin

• Summary

Cesarean Delivery Pre-incision prophylaxis

• Antibiotics

• VTE prophylaxis

• Tilt

• Indwelling Foley catheterization

• Vaginal irrigation

Prophylactic antibiotics

• > 81 RCTs !!

• fever by 70%

• endometritis by >60% (primary=repeat)

• wound infection by 25-65%

• UTI

Hopkins L, Smaill FM. Cochrane 2009;1.

Prophylactic antibiotics YES!

• When? – 30min before incision

• Which one? – Amp = 1st generation cephalosporins

– No benefit from broader spectrum agents (except not pre-CD, high-risk MU), or from multiple antibiotics

• What dose? – No added benefit from multiple doses (1 enough)

Costantine MM, et al. AJOG 2008;199:301; 6 RCTs

ACOG CO 2011; Mackeen Cochrane in progress

Hopkins L, Smaill FM. Cochrane 2009;1

Thromboprophylaxis YES

• All women:

– Mechanical prophylaxis (compression stockings or

pneumatic compression device) during/after CD until ambulation

• Additional risk factors (e.g. morbid obesity, prior VTE, long-term immobility, etc)

– Medical prophylaxis (e.g. with prophylactic heparin post CD)

Tooher R, et al. Cochrane 2010, 5

ACOG 2011; SMFM 2011

Lateral Tilt May be

• 10-15 degrees

• 3 RCTs, 293 women

• low Apgar scores

• pH

• oxygen saturation

• Limited evidence for efficacy

Crawford BrJAnaesth 72;44:477

Clemetson OG 73;42:290

Downing Anaesthesia 74;29:696

Carbonne OG 96;88:797

Cluver C, et al. Cochrane 2010, 6

Vaginal irrigation Probably not necessary if pre-incision antibiotics, etc

• Povidone-iodine (5 RCTs, n=1766)

– Lower Endometritis

• 3.6% vs 7.2%; RR 0.39, 95% CI 0.16 to 0.97

– Antibiotics an issue

• Chlorexidine

– No effect

Haas DM et al Cochrane 2010 (5 RCTs)

Cutland CL, et al. Lancet 2009;374:1909-16 (South Africa)

Indwelling urinary catheter Need better evidence

• More UTIs

• No difference in

– Urinary retention

– OR difficulties

• Incidence injury in 1,000 CDs in literature:

– Bladder: 1.4

– Ureter: 0.3

Ghoreishi et al IJGO 2003 (RCT, n=270, Iran, antib?)

Nasr et al J Perinat 2009 (RCT, n=420, Egypt, antib?)

Wen et al. BJOG 2010 (meta-analysis, 2 RCT and 1 NRCT)

Oxygen supplementation No

• 10L non-rebreather mask during and for 2h pp, vs

• 2L NC

• Similar incidence of infection

Shifres et al AJOG 2011 (RCT)

Gardella et al OG 2008 (RCT)

Shaving Usually no

• Discomfort

• No RCT

• Clipping around skin edge (at most)

Drapes Non-adhesive

• Adhesive: ↑ wound infection

• 2 RCTs

Cordtz, T, et al. J Hosp Infect 1989; 13:267

Ward, HR, et al. J Hosp Infect 2001; 47:230

Skin Cleansing Chlorhexidine-alcohol

• 1 RCT, 100 women (all Parachlorometaxylenol 5min, then)

• 7.5% povidine-iodine scrub, then p-i 10% solut.

• No difference in endometritis / wound infection

• Chrorhexidine-alcohol better than povidone-iodine

Magann OG 93:81:922

Darouiche, RO, et al. NEJM 2010; 362:18

Wylie BJ, et al. Obstet Gynecol 2010;115:1134-40 (NICHD)

Skin incision Transverse

Pfannensteil vs Joel-Cohen vs Stark (Misgav Ladach)

Studied with other aspects (Table 3)

Compared to vertical

– + 1 min for primary

– + 2 min for repeat

Length: Allis clamp (15cm)

Dissection of fascia off rectus muscle May not be necessary

• 1 small (n=120) RCT

• Lower hgb level

• More pain (visual analog scale)

• No benefits

Kadir RA, et al. EJOGRB 2006

Bladder Flap Avoid (3 RCTs)

• 1 RCT, 102 women (1ary) • 7 vs 5min incision-delivery interval • 40 vs 35min total operating time • 1 vs 0.5g/dL change in hgb • 47 vs 21% hematuria • 55 vs 26% need for analgesia at 2 days • ? Long-term effects

Hohlagschwandtner OG 01;98:1089

Bladder Flap 2nd RCT

• 1 RCT, 258 women (1ary and repeat) • 10 vs 9min incision-delivery interval • Similar

• Total operating time, change in hgb, hematuria

• No bladder injuries • ? Long-term effects

More adhesions at repeat cesarean

Tuuli M et al OG 2012;119:815 (April, Wash U)

Malvasi et al EJOGRB 2011

Uterine incision Transverse

Compared to vertical less blood loss easier to perform and repair possible future TOLAC

Uterine incision Blunt expansion (4 RCTs)

• 147 sharp (scissors), 139 blunt (fingers)

• Extensions 14 vs 12%

• Hgb 9.9 vs 10.3 g/dL

• No serious morbidities

Rodriguez AJOG 94;171:1022

Uterine incision Blunt expansion (2nd RCT)

• 470 sharp, 475 blunt

• EBL

• hematocrit

• transfusion (65% higher risk)

• uterine extensions (>50% higher risk)

• broad lig., uterine art., cervical (NS)

• ‘Sharp expansion significantly increases blood loss and need for transfusion’

Magann BJOG 02;109:448 (Mississippi)

Dodd et al. Cochrane 2008: ↓ EBL

Uterine incision blunt expansion

Cephalad-caudad

Cromi A, et al. AJOG 2008;199:292

Compared to transverse (1 RCT, n=>800)

unintended extensions

blood loss

Extraction of fetus with impacted head Pull method?

Fasubaa OB, et al. J Obstet Gynecol 2002;22:375-8 (Nigeria, n=108)

Compared to ‘push from below’

operating time

extension of uterine incision

postpartum endometritis

Prevention pp hemorrhage (Prophylactic uterotonic)

Oxytocin or carbetocin

Munn MB, Owen J, et al. Obstet Gynecol 2001;98:386-90

Oxytocin 10-40u over 4-8hrs (Several RCTs)

• Compared to 20u, 80u oxytocin

• use other uterotonics

Alternative: carbetocin use other uterotonics (2 Canada RCTs)

Misoprostol (primary or additional) not necessary (5 RCTs)

Tranexanic acid pp BL, use other uterotonics (3 RCTs)

Placental removal Spontaneous with cord traction

• 15 RCTs, 4,694 women

• EBL

• endometritis

• hospital stay

Notelovitz S Afr JOG 72;10:28

McCurdy AJOG 92;166:402

Magann Surg Ob Gyn 93;177:389

Magann J Am Coll Surg 95;181:517

Atkinson OG 96;87:99

Lasley AJOG 97;176:1250

Chandra JRM 02;47:101

Anorlu RI, Maholwana B, Hofmeyr GJ. Cochrane 2008, 3

Uterine exteriorization

Compared to intra-abdominal repair

• 11 RCTs, 3,183 women

• fever (Cochrane)

• - infection, blood loss, n/v

• Easier repair

• Similar outcomes overall

Hershey OG 78;52:189

Magann Surg Gyn Ob 93;177:389

Magann J Am Coll Surg 95;181:517

Walsh CA, Walsh SR. AJOG 2009;200:625

‘Curette’ with sponge

no data

No need for opening cervix

same infection, hgb

Blunt needles

less glove perforations (1% vs 6%)

less surgeon satisfaction Sullivan et al. OG 2009 (RCT, n=194)

Parantainen A et al. Cochrane 2011 (4 RCTs on abd laparotomy)

Liabsuetrakul, et al. Cochrane 2011 (3 RCTs, n=735)

Uterine incision Close the first layer

• Continuous ( OR time and EBL)

• Locking?

• Full thickness (better 6w pp u/s)

Hohlagschwandtner M, et al. Arch Gynecol Obstet 2003;268:26-8 (non-RCT)

Bujold et al. OG 2010 (non-RCT)

Yazicioglu F, et al. Eur J Obstet Gynecol Reprod Biol 2006;124:32-6 (RCT, n=78)

Uterine incision closure Single or double layer?

Short term outcomes

• 10 RCTs, 2531 women

• OR time (6min)

• scar defects radiographically at 3mo.

• blood loss

• pain

Lal IJGO 88;27:349 (RCT, n=100, India)

Hauth AJOG 92;167:1108 (RCT, n=908, Alabama)

Dodd JM, et al. Cochrane 2008, 3

Uterine incision closure Single or Double layer

Long term outcomes

• RCT f/u (145/906 experienced labor)

• 1/70 (1) vs 0/75 (2) dehiscence (baby did well)

• Retrospective: differing results

Chapman OG 97;89:16

Tucker AJOG 93;168:545 (n=292)

Bujold AJOG 02;186:1326 (n=2142)

Bujold OG 2010;116:43-50 (n=96 ruptures; OR 2.7)

Before abdominal closure • Adhesion prevention

– No RCTs

• Intra-abdominal irrigation

– No effect

• Appendectomy

– No effect;

– Only for abnormal appearing appendix, pelvic pain

Harrigill et al. OG 2003 (RCT, n=196)

Pearce et al. AJOG 2008 (RCT, n=93)

Peritoneal Non-Closure

• 14 RCTs, 2908 women

• time (6min)

• fever

• post-op stay

• analgesic requirements

Hull OG 91;77:818 (VP)

Pietrantoni OG 91;77:293 (P)

Irion BrJOG 96;103:690 (VP)

Nagele AJOG 96;174:1366 (V)

Bamigboye AA, Hofmeyr JG. Cochrane 2010, 7

Subcutaneous Tissue Reapproximation Not for everyone

• 1 RCT in all women (n=438)

• 3-0 plain inter/cont Camper’s fascia

• Physicians not blinded

• 70% antibiotic prophyl

• 2.7min operative time difference

• 2.7 vs 7.4% wound disruptions

DelValle OG 92;80:1013

Anderson ER, Gates S. Cochrane 2008, 4

Subcutaneous Tissue 2cm fat Close with sutures

• 7 RCTs, 2056 women

• wound complications by >30%

• hematoma

• seroma

• infection

• separation Naumann OG 95;85:412 (c; n=245)

Allaire JRM 00;45:327 (c,d; n=76)

Magann AJOG 02;186:1119 (c,d; n=590)

Anderson ER, Gates S. Cochrane 2008, 4

Subcutaneous Tissue 2cm fat No drainage

• 6 RCTs, >1000 women

• - wound complications

• - hematoma

• - seroma

• - infection

• - separation Allaire JRM 00;45:327 (c,d; n=76)

Magann AJOG 02;186:1119 (c,d; n=590)

Hellums et al. AJOG Sept 2007 (meta-analysis)

Gates S, Anderson ER. Cochrane 2009, 3

Skin Closure Sutures or staples

• 8 RCTs, 1665 women (mostly small studies)

• Large studies underpowered

• Similar outcomes, except

– Staples

• quicker, ↑ wound separation if removed <4days

• Insufficient, contradictory evidence

Frishman et al. JRM 97;42:627 (n=50)

Gaertner I et al. EJOGRB 2008;138:29 (n=153)

Rousseau, JA, et al. AJOG 2009;200:265 (n=101)

Cromi A, et al. AJOG 2010;203:36.e1-8 (n=123)

Basha et al. AJOG 2010;203:285 (n=435)

Mackeen, Berghella, Larsen. Cochrane 2012

CROSS

• RCT, n=746 (TJU n=480)

• Sutures

– Less wound complications (4.9% vs. 10.6%; OR 0.43, 95% CI 0.23, 0.78)

• Less wound separation (1.6% vs. 7.4%; OR 0.20, 95% CI 0.07, 0.51)

– Better patient satisfaction (10 vs 9, p<0.01)

– Better objective and subjective cosmesis

• PSAS 15 vs 20, p=0.01

• OSAS 12 vs 13, p=0.01

Mackeen et al, OG 2014

Days of staple removal

Summary

• Antibiotics – 30min prior, Amp or Ancef, 1 dose

• VTE prophylaxis

• No drapes

• Skin cleansing – Chrorhexidine-alcohol

• Uterine incision – Transverse, blunt expansion, cephalad-caudad

Summary • Oxytocin 20-40u

• Placental removal – Spontaneous with cord traction

• Uterine exteriorization - safe

• Closure of uterine incision – single layer if BTL: continuous and full-thickness; more

data on long-term outcome

• No peritoneal closure

• Subcutaneous tissue closure if 2cm

• Closure of skin – SUTURE!

[email protected]

www.cdc.gov/nchs/; www.healthypeople.gov

Behind the Numbers

Healthy

People 2020

VBAC goal

Healthy

People 2020

1ary LR CD

goal (23.9%)

The Healthy People challenge

32.9% in 2009

26.5% in 2007

NOT Major focus