Obstetric Hemorrhage:How Patient Safety Bundles Can Help

Improve Outcomes

Christian A. Chisholm, MDWendy A. Graefe, MSN, CNM

Virginia Neonatal Perinatal Collaborative

December 5, 2018

• We have no conflicts of interest to disclose relevant to this presentation

• Review the epidemiology of obstetric hemorrhage and its impact on maternal morbidity and mortality

• Discuss evidence-based strategies to mitigate the risk associated with obstetric hemorrhage

• Review strategies for readiness and response to unanticipated hemorrhage

Objectives

• Traditional definition: > 500 mL after vaginal birth, >1000 mL after cesarean

• ReVITALize definition: >1000 mL cumulative blood loss within 1st 24 hours after delivery

• Emphasis placed on

• quantity of blood loss necessary to cause physiologic instability

• extended period of risk for clinically important bleeding

• Incidence: approximately 4-5% of births

Obstetric hemorrhage - Incidence

• Uterine atony (80% of total)

• Genital tract laceration

• Abnormal placentation

• Previa

• Morbidly adherent placenta

• Abruption

• Retained placenta

• Uterine inversion

• Maternal coagulopathy

• Hereditary

• Acquired

Obstetric hemorrhage - etiologies

• Leading direct cause of maternal death worldwide

• Leading cause of severe maternal morbidity in US

• Accounts for 10% of maternal deaths in US• Survival from hemorrhage associated with

increased rates of:• Blood product transfusion

• Peripartum hysterectomy

• Critical illness: ARDS, shock, DIC, acute renal failure

Obstetric hemorrhage - impact

US Pregnancy-Related Death

Pregnancy-Related Mortality in the United States, 2006–2010

Creanga, Andreea A.; Berg, Cynthia J.; Syverson, Carla; Seed, Kristi; Bruce, F. Carol; Callaghan, William M.

Obstetrics & Gynecology125(1):5-12, January 2015.

doi: 10.1097/AOG.0000000000000564

US:

26/100,000

Other developed

countries:

12/100,000

Table 2

Causes of Pregnancy-Related Death by Outcome of Pregnancy: United States, 2006–2010

Pregnancy-Related Mortality in the United States, 2006–2010

Creanga, Andreea A.; Berg, Cynthia J.; Syverson, Carla; Seed, Kristi; Bruce, F. Carol; Callaghan, William M.

Obstetrics & Gynecology125(1):5-12, January 2015.

doi: 10.1097/AOG.0000000000000564

Copyright © 2018 by The American College of Obstetricians and Gynecologists 9

Fig. 3

Cause-specific proportionate pregnancy-related mortality: United States, 1987–2010.Creanga. Pregnancy-Related Mortality in the United States. Obstet Gynecol 2015.

Pregnancy-Related Mortality in the United States, 2006–2010

Creanga, Andreea A.; Berg, Cynthia J.; Syverson, Carla; Seed, Kristi; Bruce, F. Carol; Callaghan, William M.

Obstetrics & Gynecology125(1):5-12, January 2015.

doi: 10.1097/AOG.0000000000000564

Copyright © 2018 by The American College of Obstetricians and Gynecologists 10

• AIM Obstetric Hemorrhage Patient Safety Bundle

• Readiness

• Recognition and Prevention

• Response

• Reporting/Systems Learning

• https://safehealthcareforeverywoman.org/patient-safety-bundles/obstetric-hemorrhage/

Mitigating the Risk

• Hemorrhage cart – supplies, checklist, instructions for tamponade balloons and compression stitches

• Hemorrhage medications – kit or equivalent

• Response team [surgical backup, interventional radiology, transfusion medicine]

• Emergency release and massive transfusion protocols

• Unit education, drills, de-briefs

Readiness

Hemorrhage Cart

Emergency Blood Release / Massive Transfusion

ORDERING BLOOD PRODUCTS

3 PATHWAYS University of Virginia Health System Aug. 2017

TYPE

TURNAROUND TIME ORDER CLINICAL GUIDELINES PRODUCT DELIVERY SYSTEM

ROUTINE < 30

minutes if no antibodies

EPIC

✓ HEMODYNAMICALLY STABLE

PATIENT AS ORDERED TUBE SYSTEM

FASTBLOOD

4+2

< 15 minutes

CALL 4-2012

To ACTIVATE

FastBlood 4+2

“One and done” →

No need to deactivate

✓ URGENT NEED

✓ ESTIMATED / PREDICTED ACUTE

BLOOD LOSS > 750 mL

✓ HEART RATE > 100 bpm

✓ SYSTOLIC BP < 100 mm Hg

✓ ABC TRAUMA SCORE 0 OR 1

4 RBC

2 FFP

NOT RECURRENT

ONE AND DONEALL IN ONE COOLER

Delivered by Transportation

MTPMASSIVE TRANSFUSION

PROTOCOL

< 15 minutes to first cooler

CALL 4-2012

To ACTIVATE MTP

CALL 4-2012

To DEACTIVATE MTP

✓ EMERGENT NEED

✓ ESTIMATED / PREDICTED ACUTE

BLOOD LOSS > 1500 mL

✓ HEART RATE > 120 bpm

✓ SYSTOLIC BP < 90 mm Hg

✓ ABC TRAUMA SCORE 2 OR

GREATER

1st COOLER

4 RBC

2 FFP

ALL IN ONE COOLER Delivered

by Transportation

2nd and SUBSEQUENT COOLERS

6 RBC

4 FFP

1 PLT

1 CRYO

• RED CELLS – in one

cooler

• FFP – in other cooler

• PLT – IN HAND (not in

cooler)

• CRYO – about every

other round – IN HAND

(not in cooler)

o Cryo is stored

frozen, so it

must be

thawed before

it is ready

• Anti-fibrinolytic agent utilized in multiple settings (trauma, orthopedics) for prevention and management of blood loss

• Prospective RCT of over 20,000 women

• Randomized to 1000 mg of TXA given over 10 minutes vs placebo

• Primary outcome was death from all causes OR hysterectomy

• not reduced by study intervention

• Death caused by hemorrhage was reduced

• (1.5% TXA vs 1.9% placebo), RR 0.81, [0.65-1.00]

• Death caused by hemorrhage (when TXA was administered within 3 hours of onset of hemorrhage) was reduced

• (1.2% TXA vs 1.7% placebo), RR 0.69, [0.52-0.91]

Tranexamic Acid (WOMAN trial results)

• Assessment of hemorrhage risk

• Measurement of cumulative blood loss

• Active management of 3rd stage of labor

• [Morbidly adherent placenta protocols]

• Although not part of the AIM bundle, MAP management protocols logically belong here

Recognition and Prevention

• Screening tools• CMQCC• AWHONN

• Adopt a screening tool and use it universally

• Identify factors which increase the risk of hemorrhage

• Communicate increased risk of specific patients to all team members• Frequent reassessment during labor and post-

partum• Consider holding standing Safety Rounds at regular

intervals

Risk screening

CMQCC Hemorrhage Risk Assessment

AWHONN Hemorrhage Risk Assessment

Oklahoma Hemorrhage Risk Assessment: Admission

Low Risk Medium Risk High Risk

No previous uterine incision Prior cesarean birth or uterine

surgery

Placenta previa, low lying placenta

Singleton pregnancy Uterine over distention ( multiple

gestation, polyhydramnios, fetus

> 4 kg)

Suspected placenta accreta,

percreta, or increta

Greater than 4 previous vaginal

births

Hematocrit less than 30% AND

other risk factors present

Less than or equal to 4 previous

vaginal births

Chorioamnionitis Platelets less than 100,000

No known bleeding disorder History of previous PPH Known coagulopathy

No history of PPH Large uterine fibroids or abnormal

uterine anatomy

Active bleeding-greater than

normal show

Plan of Care

Low Risk Medium Risk High Risk

• Type & Screen

• If prenatal antibody screen positive

(except low level anti-D from

Rhogam) – Type & Crossmatch 2

units PRBCs

• Type & Screen

• Review Hemorrhage Protocol

• Notify OB provider, anesthesia,

charge nurse, surgery

• Type & Crossmatch 2 units PRBCs

per order

• Review Hemorrhage Protocol

Identify women who may decline transfusion

• Notify OB provider for plan of care

• Early consult with anesthesia

• Review refusal of blood products protocol/consent form

Evaluate for risk factors on admission, throughout labor, first 24 hours postpartum, and at every hand off.

Oklahoma Hemorrhage Risk Assessment: Post-deliveryNotify care provider of worsening assessment. More than one medium risk factor moves patient into High Risk category.

Evaluate for risk factors on admission, throughout labor, first 24 hours postpartum, and at every hand off.Low Risk Medium Risk High Risk

Retained placenta

Cesarean birth or uterine surgery Hematocrit less than 30% AND other risk

factors present Singleton pregnancy Uterine over distention (multiple

gestation, polyhydramnios, fetus

> 4 kg)

No known bleeding disorder Greater than or equal to 5 vaginal births Platelets less than 100,000

No history of PPH History of previous PPH Known coagulopathy

Uncomplicated vaginal delivery Prolonged oxytocin use Active bleeding-more than normal lochia

No genital tract trauma Prolonged 2nd stage

Rapid labor

Large uterine fibroids or uterine anomaly

Magnesium Sulfate treatment

Genital tract trauma

Low Risk Medium Risk High Risk

Post Delivery Plan of Care

• Routine recovery

• Ongoing Quantitative Evaluation of Blood Loss

• Routine recovery with heightened awareness

for bleeding

• Ongoing Quantitative Evaluation of Blood Loss

• Type & Screen

• Review Hemorrhage Protocol

• Routine recovery with heightened awareness

for bleeding

• Ongoing Quantitative Evaluation of Blood Loss

• Notify OB provider, anesthesia, charge nurse,

surgery

• Type & Cross match 2 units PRBCs

• Review Hemorrhage Protocol

Post Recovery Plan of Care : First 24 hours

• If initial post recovery assessment is Low

Risk, reassess every 8 hours or more often

as condition necessitates.

• Reassess bleeding and fundus every 4

hours or more often as condition

necessitates

• Reassess bleeding and fundus every 4

hours or more often as condition

necessitates

Admission Risk Assessment & Testing

Low

(Clot only)

Medium

(Type and Screen)

High

(Type & Crossmatch)

No previous uterine incision

Prior cesarean birth(s) or uterine surgery

Placenta previa, low lying placenta

Singleton pregnancy Multiple gestation Suspected placenta accreta, percreta, increta

≤4 previous vaginal births

>4 previous vaginal births

Hematocrit <30 ANDother risk factors

No known bleeding disorder

Chorioamnionitis Platelets <100,000

No history of PPH History of previous PPH

Active bleeding (greater than show) on admit

Large uterine fibroids Known coagulopathy *Pre-transfusion testing strategy should be standardized to facility conditions depending

on blood bank resources, speed of testing, and availability of blood products.*

• Transfusion utilization ~1.6% of births

• Protocol options: universal T&S with crossmatch for high risk patients (highest preparation; most cost); no routine admission testing for any patient (lowest preparation, least cost); intermediate strategies

• Einerson et al (2017): cost-effectiveness analysis showed that universal T&S was not cost-effective in a wide range of scenarios; policy of “hold clot only” with crossmatch for high risk patients was most cost-effective

• Not tested in actual use; hypothetical model; cost-effectiveness was measured against prevention of emergency release blood utilization

• Bottom line – each unit should decide their standard strategy for crossmatching and apply it consistently

Blood Transfusion Readiness

• Initiation of oxytocin (IV or IM) immediately upon delivery of the anterior shoulder of the baby, either at the time of vaginal or cesarean birth

• Other components included in research and clinical protocols have included controlled cord traction and vigorous fundal massage

• Oxytocin is the key element

• Other components not proven to impact blood loss

• Compatible with delayed cord clamping

Active Management of Third Stage (AMTSL)

• AMTSL leads to reduction in the following outcomes:

• Risk of blood loss >1000 mL

• Risk of blood loss >500 mL

• Post-partum hemoglobin <9 g/L

• Mean maternal blood loss

• Maternal transfusion

• Need for use of uterotonics

Active Management of Third Stage (AMTSL)

Quantified Blood Loss

Quantified Blood Loss

• AWHONN video (basics)• https://www.youtube.com/watch?v=F_ac-aCbEn0

• Requires system planning• Knowledge of dry weight of commonly used items (lap

pads, blue towels, chux)

• Availability of calibrated drapes and standard work surrounding the documentation

• Often integrated into EMR

• Standard, stage-based obstetric hemorrhage emergency management plan with checklists

• Support program for patients, families and staff for significant hemorrhages

Response

Hemorrhage Guidelines: Staged Responses

Pre-Admission: All patients-Assess Risk

Stage 0: All birth- Routine Measures

Stage 1: QBL > 500 mL vag or 1000 mL CS or VS unstable with continued bleeding

Stage 2: QBL 1000-1500 mL with continued bleeding

Stage 3: QBL exceeds 1500 mL

Cu

mu

lati

ve Q

BL

Active Management ofThird Stage

Every hospital will need to customize the protocol—

but the point is every hospital needs one

CMQCC OB Hemorrhage Emergency Management Plan

Copyright California Department of Public Health, 2014; supported by Title V funds. Developed in partnership with California Maternal Quality Care Collaborative Hemorrhage Taskforce Visit: www.CMQCC.org for details

Obstetric Hemorrhage Emergency Management Plan: Table Chart Format version 2.0

Assessments Meds/Procedures Blood Bank

Stage 0 Every woman in labor/giving birth

Stage 0 focuses on risk assessment and active management of the third stage.

· Assess every woman for risk factors for hemorrhage

· Measure cumulative quantitative blood loss on every birth

Active Management 3rd Stage:

· Oxytocin IV infusion or 10u IM

· Fundal Massage-vigorous, 15 seconds min.

· If Medium Risk: T & Scr

· If High Risk: T&C 2 U

· If Positive Antibody Screen (prenatal or current, exclude low level anti-D from RhoGam):T&C 2 U

Stage 1 Blood loss: > 500ml vaginal or >1000 ml Cesarean, or

VS changes (by >15% or HR ³110, BP £85/45, O2 sat <95%) Stage 1 is short: activate hemorrhage protocol, initiate preparations and give Methergine IM.

· Activate OB Hemorrhage Protocol and Checklist

· Notify Charge nurse, OB/CNM, Anesthesia

· VS, O2 Sat q5’

· Record cumulative blood loss q5-15’

· Weigh bloody materials

· Careful inspection with good exposure of vaginal walls, cervix, uterine cavity, placenta

· IV Access: at least 18gauge

· Increase IV fluid (LR) and Oxytocin rate, and repeat fundal massage

· Methergine 0.2mg IM (if not hypertensive) May repeat if good response to first dose, BUT otherwise move on to 2nd level uterotonic drug (see below)

· Empty bladder: straight cath or place foley with urimeter

· T&C 2 Units PRBCs (if not already done)

Stage 2 Continued bleeding with total blood loss under 1500ml

Stage 2 is focused on sequentially advancing through medications and procedures, mobilizing help and Blood Bank support, and keeping ahead with volume and blood products.

OB back to bedside (if not already there)

· Extra help: 2nd OB, Rapid Response Team (per hospital), assign roles

· VS & cumulative blood loss q 5-10 min

· Weigh bloody materials

· Complete evaluation of vaginal wall, cervix, placenta, uterine cavity

· Send additional labs, including DIC panel

· If in Postpartum: Move to L&D/OR

· Evaluate for special cases: -Uterine Inversion -Amn. Fluid Embolism

2nd Level Uterotonic Drugs: · Hemabate 250 mcg IM or · Misoprostol 800 mcg SL

2nd IV Access (at least 18gauge)

Bimanual massage Vaginal Birth: (typical order)

· Move to OR

· Repair any tears

· D&C: r/o retained placenta

· Place intrauterine balloon

· Selective Embolization (Interventional Radiology)

Cesarean Birth: (still intra-op) (typical order)

· Inspect broad lig, posterior uterus and retained placenta

· B-Lynch Suture

· Place intrauterine balloon

· Notify Blood Bank of OB Hemorrhage

· Bring 2 Units PRBCs to bedside, transfuse per clinical signs – do not wait for lab values

· Use blood warmer for transfusion

· Consider thawing 2 FFP (takes 35+min), use if transfusing > 2u PRBCs

· Determine availability of additional RBCs and other Coag products

Stage 3 Total blood loss over 1500ml, or >2 units PRBCs given or VS unstable or suspicion of DIC

Stage 3 is focused on the Massive Transfusion protocol and invasive surgical approaches for control of bleeding.

· Mobilize team -Advanced GYN surgeon -2nd Anesthesia Provider -OR staff -Adult Intensivist

· Repeat labs including coags and ABG’s

· Central line

· Social Worker/ family support

· Activate Massive Hemorrhage Protocol

· Laparotomy: -B-Lynch Suture -Uterine Artery Ligation -Hysterectomy

· Patient support -Fluid warmer -Upper body warming device -Sequential compression stockings

Transfuse Aggressively Massive Hemorrhage Pack

· Near 1:1 PRBC:FFP

· 1 PLT apheresis pack per 4-6 units PRBCs

Unresponsive Coagulopathy: After 8-10 units PRBCs and full coagulation factor replacement: may consult re rFactor VIIa risk/benefit

Blood Loss:

1000-1500 ml

Stage 2

Sequentially

Advance through

Medications &

Procedures

Pre-

Admission

Time of

admission

Identify patients with special consideration:

Placenta previa/accreta, Bleeding disorder, or

those who decline blood products

Follow appropriate workups, planning, preparing of resources, counseling and notification

Screen All Admissions for hemorrhage risk:

Low Risk, Medium Risk and High Risk

Low Risk: Draw blood and hold specimen

Medium Risk: Type & Screen, Review Hemorrhage Protocol

High Risk: Type & Crossmatch 2 Units PRBCs; Review Hemorrhage

Protocol

All women receive active management of 3rd

stage

Oxytocin IV infusion or 10 Units IM, 10-40 U infusion

Standard Postpartum

Management

Fundal Massage

Vaginal Birth:

Bimanual Fundal Massage

Retained POC: Dilation and Curettage

Lower segment/Implantation site/Atony: Intrauterine Balloon

Laceration/Hematoma: Packing, Repair as Required

Consider IR (if available & adequate experience)

Cesarean Birth:

Continued Atony: B-Lynch Suture/Intrauterine Balloon

Continued Hemorrhage: Uterine Artery Ligation

To OR (if not there);

Activate Massive Hemorrhage Protocol

Mobilize Massive Hemorrhage Team

TRANSFUSE AGGRESSIVELY

RBC:FFP:Plts 6:4:1 or 4:4:1

Increased

Postpartum

Surveillance

Definitive Surgery

Hysterectomy

Conservative Surgery

B-Lynch Suture/Intrauterine Balloon

Uterine Artery Ligation

Hypogastric Ligation (experienced surgeon only)

Consider IR (if available & adequate experience)

Fertility Strongly Desired

Consider ICU

Care; Increased

Postpartum

Surveillance

Verify Type & Screen on prenatal

record;

if positive antibody screen on prenatal

or current labs (except low level anti-D

from Rhogam), Type & Crossmatch 2

Units PBRCs

CALL FOR EXTRA HELP

Give Meds: Hemabate 250 mcg IM -or-

Misoprostol 600-800 SL or PO

Cumulative Blood Loss

>500 ml Vag; >1000 ml CS

>15% Vital Sign change -or-

HR ≥110, BP ≤85/45 O2 Sat <95%, Clinical Sx

Ongoing

Evaluation:

Quantification of

blood loss and

vital signs

Unresponsive Coagulopathy:

After 10 Units PBRCs and full

coagulation factor replacement,

may consider rFactor VIIa

HEMORRHAGE CONTINUES

Blood Loss:

>1500 ml

Stage 3

Activate

Massive

Hemorrhage

Protocol

Blood Loss:

>500 ml Vaginal

>1000 ml CS

Stage 1Activate

Hemorrhage

Protocol

NO

Stage 0All Births

Transfuse 2 Units PRBCs per clinical

signs

Do not wait for lab values

Consider thawing 2 Units FFP

YES

YES NO

On

go

ing

Cum

ula

tive

Blo

od

Lo

ss E

valu

ation

Cumulative Blood Loss

>1500 ml, 2 Units Given,

Vital Signs Unstable

YESIncrease IV Oxytocin Rate

Methergine 0.2 mg IM (if not hypertensive)

Vigorous Fundal massage; Empty Bladder; Keep Warm

Administer O2 to maintain Sat >95%

Rule out retained POC, laceration or hematoma

Order Type & Crossmatch 2 Units PRBCs if not already done

Activate Hemorrhage Protocol

CALL FOR EXTRA HELP

Continued heavy

bleeding

Increased

Postpartum

Surveillance

NO

NO

CONTROLLED

INCREASED BLEEDING

California Maternal Quality Care Collaborative (CMQCC), Hemorrhage Taskforce (2009) visit: www.CMQCC.org for details

This project was supported by funds received from the State of California Department of Public Health, Center for Family Health; Maternal, Child and Adolescent Health Division

Obstetric Emergency Management Plan: Flow Chart Format Release 2.0 7/9/2014

• Huddles for high risk patients, post-event debriefing to identify successes and opportunities

• Multidisciplinary review of serious hemorrhages for systems issues

• Monitor outcomes and process metrics in perinatal QI committee

Reporting/Systems Learning

• Drills, team training

• Massive transfusion protocols

• Factor replacement

Unanticipated hemorrhage

• American College of Obstetricians and Gynecologists, Postpartum Hemorrhage. Practice Bulletin 183, October 2017

• Association of Women’s Health, Obstetric and Neonatal Nurses. The AWHONN postpartum Hemorrhage Project, 2015.

• California Maternal Quality Care Collaborative, Planning for and Responding to Obstetric Hemorrhage. March 2015.

• Einerson BD et al. Transfusion preparedness strategies for obstetric hemorrhage. A cost-effectiveness analysis. ObstetGynecol 2017;130:1347-55.

• Patterson JA et al. Blood transfusion during pregnancy, birth, and the postnatal period. Obstet Gynecol2014;123:126-33.

Selected References

• Creanga AA et al. Pregnancy-related mortality in the United States 2006-2010. Obstet Gynecol 2015;125:5-12.

• WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum hemorrhage (WOMAN): an international, randomized, double-blind, placebo-controlled trial. Lancet 2017;389:2105-16.

• Begley CM et al. Active versus expectant management for women in the third stage of labour. Cochrane Database of Systematic Reviews 2015; DOI 10.1002/14651858.CD007412.pub4.

Selected References