Reducing Maternal Mortality Through Clinical Protocols Mary E. D’Alton, M.D. Willard C. Rappleye Professor and Chair, Department of Obstetrics & Gynecology

Columbia University College of Physicians & Surgeons

CONFLICT OF INTEREST DISCLOSURE STATEMENT • I have no significant financial interest with any commercial or corporate enterprise. • I shall not discuss any off-label usage of any FDA-approved medications or other products.

The Problem:

Yearly Rate of Change in Maternal Mortality Ratio,1990–2008

Hogan MC, et al. Lancet 2010.

US Maternal Mortality Ratio: What is the Trend?  Maternal mortality ratio rose from 10.0 to 14.5 per 100,000 between 1990 and 2006  Changes in the National Vital Statistics System may have improved ascertainment of maternal death  Maternal mortality is NOT DECREASING in the US, despite advancements of modern medicine Berg CJ et al. Obstet Gynecol 2010, Callaghan WM, Semin Perinatol 36:2-6

US Pregnancy-Related Mortality 35

Mortality (%)

30 25 20 15 10 5 0

Berg CJ et al. Obstet Gynecol 2010.

Factors Increasing Maternal Mortality and Morbidity    

Maternal age Obesity Cesarean delivery More pregnancies in women with significant chronic medical conditions • • • •

Hypertension Pregestational diabetes Congenital heart disease Organ transplant

Opportunities to Reduce Maternal Death  UK triennial “Saving Mothers’ Lives” 2011 report found major substandard care in:   

64% of deaths due to hypertensive disease 33% of deaths due to thromboembolism 44% of deaths due to hemorrhage

 North Carolina mortality review 1995-1999 

40% of maternal deaths preventable

 Hospital Corporation of America 2000-2006 

27% of maternal deaths preventable

 New York State Safe Motherhood Initiative 2008-2009 

35% of maternal deaths preventable

Case presentation 34 yo G3P0020 presented at 33 1/7 weeks with Preterm PROM  No significant medical or surgical history  BMI 22  Was given betamethasone and latency antibiotics  48 hours after admission, spontaneous PTL  Arrest of dilation, face presentation  Underwent uncomplicated primary LTCD  Perioperative DVT prophylaxis: sequential compression devices (SCDs), early ambulation

Case presentation Postoperative course  On POD1 fell to the floor & was unresponsive  CPR was performed, sinus rhythm was restored  Transferred intubated to CCU  Saddle pulmonary embolus on CT angio  Right heart failure on echo  Never re-gained consciousness  Cerebral edema, pupils fixed  Support was removed on POD9

The Solution: Prevention  Health Corporation of America 1,461,270 births from 2000-2006  27% of deaths were preventable  Conclusion: ‘Given the diversity of causes of maternal death, no systematic reduction can be expected unless all women undergoing cesarean delivery receive thromboembolism prophylaxis.’ Clark et al. Am Journal Of Obstet Gynecol 2008

UK Comprehensive National Effort  Standard protocols  Saving Mothers Lives, U.K. Saving Mothers’ Lives: Reviewing maternal deaths to make motherhood safer: 2006–2008. Eighth Report, Confidential Enquiries into Maternal Deaths in the United Kingdom, BJOG Volume 118, Issue Supplements 2011

• National confidential enquiry system into maternal deaths published every 3 years • Goal to identify remediable factors to address in guidelines created by national organizations

Direct Deaths per Million Maternities by Cause - UK 1994-2008

Saving Mothers’ Lives 2006-2008, National Launch, March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG

Evidence for VTE Prophylaxis  Cochrane Review in 2011 included 10 controlled trials and 6800 patients, compared combination therapy (compression + prophylactic anticoagulation) to compression alone  Combination therapy decreased the odds of PE and DVT by 60% when compared to compression alone Outcome (combination vs. compression alone

No. of studies

No. of participants

Odds Ratio (95% CI)

PE

6

4755

0.39 (0.25, 0.63)

DVT

4

2136

0.43 (0.24, 0.76)

Kakkos et al. The Cochrane Database of Systematic Reviews 2011

VTE Prophylaxis Uptake The uptake of both anticoagulation and compression nationwide is improving, but is still suboptimal





Of 1,263,205 patients who underwent CD in 600 hospitals in the in the US: 91% had no prophylaxis of any form in 2003 compared with 58% in 2010.

Friedman, D’Alton et al. Obstet Gynecol In Press

Relevance of Protocols • • • • • •

Should be derived from evidence-based data Define the standard of care Minimize variability Reduce the need to rely on memory Enhance patient safety Reduce duplication of effort

Risk of first thromboembolism in and around pregnancy 800

Rate of VTE per 1000000 person years

700 600 500 400 300 200

Antepartum

5th week

6th week

4th week

3rd week

1st week

2nd week

40th week

39th week

38th week

37th week

36th week

32-35 week

28-31 week

25-27 week

1-12week

13-24 week

0

Late…

100

Postpartum Sultan et al Br J Haematol 156, Issue 3, 366-373

New York Presbyterian VTE Protocol for Cesarean Delivery  Perioperative VTE prophylaxis is comprised of   

SCDs before CD and postop when not ambulatory Anticoagulation therapy Early ambulation

 Anticoagulation therapy  

Unfractionated heparin (UFH) 5000 units every 12h started when the pt is discharged from the PACU (~2h) Low molecular weight heparin (LMWH), dose is weight based and is started no sooner than 6 hours after CD

NYP VTE Protocol  Contraindications to heparin prophylaxis  Active PPH or coagulopathy  High probability of returning to OR for re-op for bleeding  Bleeding diathesis  Thrombocytopenia ( 18.0 13.0 -18.0 1 week – 1 month

35

21.7

> 1 month – 1 year

16

8.9

Unknown

3

1.9

Total

161

100

Source: NYC DOH, New York City Maternal Mortality Review Project Team

Clinical group recommendations: Protocols  Protocols to manage the three leading causes of maternal mortality should be available and implemented at all centers:  Obstetric hemorrhage  Thromboembolism prophylaxis  Hypertensive diseases of pregnancy

Clinical group recommendations: Maternal Early Warning System (MEWS)  Obstetric centers should utilize an early warning system to detect abnormal physiologic parameters that precede critical illness  Modeled on UK early obstetric warning system (MEOWS)  Research has found these parameters to be highly sensitive and specific Singh et al. Anaesthesia 2012

Maternal Triggers • MEOWS Triggers – Response initiated for one red or two yellow triggers Parameter

Red Trigger

Yellow Trigger

Temperature

< 35 or >38

35-36

Systolic BP; mmHg

160

150-160

Diastolic BP; mmHg

>100

90-100

Heart rate

120

100-120, 40-50

Respiratory rate

30

21-30

Oxygen saturation

100

Heart rate; beats per minute

120

Respiratory rate; breaths per minute

30

Oxygen saturation; %