ectopic, early pregnancy loss, or normal pregnancy?€¦ · ectopic, early pregnancy loss, or...

40
Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First Trimester Bleeding Jody Steinauer, MD, MAS July, 2015 Disclosures July 10, 2015 I have no disclosures.

Upload: hoangminh

Post on 13-May-2018

228 views

Category:

Documents


1 download

TRANSCRIPT

Page 1: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Ectopic, Early Pregnancy Loss, or Normal Pregnancy? 

Diagnosis and Management of First‐Trimester Bleeding

JodySteinauer,MD,MASJuly,2015

Disclosures

July10,2015Ihavenodisclosures.

Page 2: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Objectives

1. Toreviewtheworkupofbleedinginthefirsttrimester.2. Toapplyevidence‐basedprinciplesto:

1. ectopicpregnancy(EP)andearlypregnancyloss(EPL)diagnoses,and

2. EPandEPLmanagementoptions.

Patient Case: Presentation

• Mayaisa26yo G1P0presentingtotheemergencyroom.

• HowdowecareforMaya?

“I’m 2 months pregnant and I’m bleeding and cramping. Am I going to lose the baby?”

Page 3: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Patient Case: H&P

• Maya’ssureLMPwas9weeksago.• ShehadapositiveUPT2weeksago.• Thisisadesiredpregnancy.• Herfirstprenatalcarevisitisscheduledfornextweek.• Herbleedingislikea“lightperiod”forthepast3days.• ShehasnohistoryofSTIsorotherriskfactorsforectopicpregnancy.

• Onexamhercervicalos isclosed.• SheisRh‐negative.

WhatcanwetellMayarightnow?

Symptomatic Early Pregnancy Evaluation

Page 4: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Symptomatic Early Pregnancy 

• Ectopicpregnancymustberuledout,butwemustbecarefultonotdiagnoseadesiredIUPasabnormal.

• TherearenewguidelinesforhCG discriminatoryzone,aswellasEPLultrasounddiagnosticcut‐offs.

• Choiceofmanagementisapreference‐sensitivedecision.

Symptomatic Early Pregnancy: Presentation

• Urgentoremergencycarevisit– Vaginalbleeding– Abdominalorpelvicpainorcramping– Passageofpregnancytissuefromthevagina– Lossofpregnancy‐relatedsymptoms– Hemodynamicinstability

• Incidentalclinicalfinding– BimanualexaminconsistentwithLMP– Ultrasoundsuggestiveofabnormalpregnancy

Page 5: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Bleeding in Early Pregnancy

• Keepthepatientinformed.– Providereassurancethatnotallvaginalbleeding&crampingsignifiesanabnormality,butavoidguaranteesthat“everythingwillbeallright.”

– Assureyouareavailablethroughouttheprocess.

• Whatdoesthebleedingmean?– Upto20%chanceofectopicpregnancy– 50%ongoingpregnancyratewithclosedcervicalos– 85%ongoingpregnancyratewithviableIUPonsono– 30%ofnormalpregnancieshavevaginalbleeding

Evaluation

• History– Riskfactorsforectopicpregnancy

• Physicalexam– Vitalsigns– Abdominalandpelvicexam

• Ultrasound– Transvaginal oftennecessary

• Lab– Rhfactor– HemoglobinorHematocrit– β‐hCG whenindicated

Isthepregnancydesired?

Page 6: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Ectopic Pregnancy 

• 1‐2%ofallpregnancies• Upto20%ofsymptomaticpregnancies• ½ofectopicpatientshavenoriskfactors• Mortalityhasdramaticallydeclined:0.5/100,000

– 6%ofpregnancy‐relateddeaths– 21deathsperyearinUS

• Earlydiagnosisimportant• Concernaboutmanagementerrors

Early Pregnancy Loss (EPL)

• 15‐20%ofclinicallyrecognizedpregnancies

• 1in4womenwillexperienceEPLintheirlifetime

• Includesallnon‐viablepregnanciesinfirsttrimester=Miscarriage

Page 7: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Positive pregnancy test, vaginal bleeding and/or abdominal pain

61% Ongoing IUP28% Spontaneous Abortion 9% Ectopic Pregnancy

Dx upon presentation (80%)

77% Ongoing IUP16% Spontaneous Abortion6% Ectopic Pregnancy

49% of all women with Ectopic Dxat presentation

Dx with additional testing (20%)

11% Ongoing IUP77% Spontaneous Abortion17% Ectopic Pregnancy

51% of all women with Ectopic Dxafter outpatient follow-up

Ectopic PregnancyGOAL: Early Diagnosis 

• Decreasedchanceofrupture(rupturecanoccuratanylevelofbetaHCGandwhetherrising,fallingorplateauing)

• Ruptureassociatedwithdecreasedfertility,increasedmorbidityandmortality

• Moretreatmentoptions(eg methotrexate,conservativesurgicaltreatment) ifdiagnosedearlier

• Methotrexatemoreeffectiveifdiagnosedearlier

Page 8: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Ectopic Diagnosis: Simplified

1. Whereisthepregnancy? U/S(sameday)2. Isthepregnancyundesired? uterineaspiration3. Ifdesiredandwecan’ttellwhereitis:Isitnormalor

abnormal? serialquantitativeBeta‐HCG– IfBhcg abovethresholdandnoIUP=Abnormal– IfBhcg drops>50%in48hours=Abnormal– IfBhcg rises>50%in48hours=Mostlikelynormal(canbeEP)– Ifbetween=Mostlikelyabnormal(stillcanbenormal)

4. Oncepregnancydeterminedtobeabnormalorifundesired uterineaspirationtodetermineifIUP,Ectopictreatmentifnot.

(Goal:Diagnoseasquicklyaspossible)

IUP=Intrauterine pregnancy

β‐hCG Utility in Symptomatic Early Pregnancy Diagnosis

• β‐hCG medianserumconcentration:– 4weeks:100mIU/ml(5‐450)– 10weeks:60,000(5,000– 150,000)

DiscriminatoryLevel• Serumβ‐hCG atwhichanormalintrauterinepregnancyshouldbevisualizedonultrasound– If>2000nl IUPunlikelybutpossible newvalues

• Oncebeyonddiscriminatorylevel,limitedrolefor“followingbetas”

Page 9: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Discriminatory & Threshold level

• 366♀withVB/pain nl IUP

• Highestseenwithnosac:2,300Oldvalues:1500=80%&2000=91%prob.

ofseeingGSinviableIUP

99%PredictedProbabilityofDetectionDiscriminatory Threshold

GestationalsacYolk sacFetalpole

351017,71647,685

39010941394

Connolly2013Obstet GynecolConnolly,Obstet Gynecol,2013.

• HCG2000‐ 3000– Non‐viablepregnancymostlikely,2Xectopic– Ectopicis19xmorelikelythanviablepregnancy– Foreachviablepregnancy:

• 19ectopicpregnancies• 38nonviablepregnancies

– 2%chanceofviablepregnancy

• HCG>3000– Ectopic70xandnonviableIUP140xmorelikelythanviablepregnancy

– 0.5%chanceofviableIUP

Inwomenwithdesiredpregnancyconsiderbetahcg cut‐offof>=3000.

Society of Radiologists in Ultrasound: No Gestational Sac

Page 10: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Balance of Diagnostic Tests

• MaximizesensitivityatthecostofdiagnosingsomeIUPsasEctopicPregnancies– Error– interruptingdesiredIUP

• MaximizespecificityatthecostofdiagnosingsomeEPsasIUPs– Error– delaydiagnosisresultinginrupture

• Engagethepatientindecision‐making• Cut‐offof3,000v.repeatbetahcg +/‐ u/s

Role of Ultrasound in Ectopic Diagnosis 

• Only2%ofu/sarediagnosticforEP– “Diagnostic”=GestationalSacwithyolksacorfetalpolevisualizedoutsideuterus

• Normaladnexalexamdoesnotexcludeectopic• Suggestiveofectopic

• Emptyuterus+hCG abovediscriminatoryzone• Complexmass+fluidincul‐de‐sac(94%areEP)• Shouldstillfollowthemifdesiredpregnancy

MainroleofU/SistoruleinIUP

Page 11: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

β HCG trends in normal IUP

Barnhart2004ObstetGynecol

99%ofnl IUPs1dayrise≥24%2dayrise≥53%

Medianrise:1day=50%2day=124%

Slowestexpected48‐hourincreasefornormalpregnancy=53%(20%ofectopics increase)

Ectopic Diagnosis: Other Key Points

• Twohcg valuesmaynotbeenough• Ifclosetothethresholds– checkanother• Presumedectopicpregnancy– uterineaspirationbeforeMTX– HighHCGnothingintheuterus(50%SAB)– VerylowHCG withabnl riseordefinitefall(25%SAB)

Barnhart, Ob Gyn, 2002

Page 12: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Ultrasound Findings to R/o EP

• RememberthatanEPhasnotbeenruledoutuntilthereisanintrauterinepregnancy– Gestationalsacwithayolksacand/orembryo

Ectopic Diagnosis: Simplified

1. Whereisthepregnancy? U/S(sameday)2. Isthepregnancyundesired? uterineaspiration3. Ifdesiredandwecan’ttellwhereitis:Isitnormalor

abnormal? serialquantitativeBeta‐HCG– IfBhcg abovethresholdandnoIUP=Abnormal– IfBhcg drops>50%in48hours=Abnormal– IfBhcg rises>50%in48hours=Mostlikelynormal(canbeEP)– Ifbetween=Mostlikelyabnormal(stillcanbenormal)

4. Oncepregnancydeterminedtobeabnormalorifundesired uterineaspirationtodetermineifIUP,Ectopictreatmentifnot.

(Goal:Diagnoseasquicklyaspossible)

IUP=Intrauterine pregnancy

Page 13: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Incomplete abortion, treat as indicated

Peritoneal signs or hemodynamic instability

Non‐obstetric cause of bleeding identified

EDDiagnose and treat 

as indicated

Threatened abortion; repeat TVUS if further 

bleeding

Transvaginal ultrasound (TVUS) and β‐hCG level

Products of conception(POC’s) visible on exam

Presume ectopic;refer for high‐level TVUS 

and/or treatment

Viable intrauterine pregnancy (IUP)

Ectopic or signs suggestive of ectopic pregnancy 

Nonviable IUP

Embryonic demise, anembryonic gestation, or retained POC’s;

discuss treatment options

Repeat TVUS in one week and/or follow serial β‐

hCG’s 

Physicalexam

Bleeding in desired pregnancy,  < 12 weeks gestation 

SeeFigure2

Figure 1.  Evaluation of first‐trimester bleeding

Patient stable, no POC’s or other cause of bleeding

No IUP, no ectopic seen

IUP, viability uncertain

IUP seen on prior TVUS?

Yes

No

Completed abortion; expectant 

management

Reproductive Health Access Project/October 2013    www.reproductiveaccess.org

First‐trimester Bleeding Algorithm

Repeat β‐hCG fell< 50% or rose < 53%***

Suggests completed 

abortion; ectopic precautions, follow β‐hCG weekly to 

zero**

β‐hCG < 1500 – 2000*

Ectopic precautions, Repeat β‐hCG in 48 hours 

Suggests viable pregnancy but does not 

exclude ectopic; follow β‐hCG until > 1500 – 2000*,

then TVUS for definitive diagnosis

Repeat β‐hCG> 1500 – 2000*

Suggests early pregnancy failure or ectopic; 

serial β‐hCG’s +/‐ high‐level TVUS until definitive 

diagnosis or β‐hCG zero**

Repeat β‐hCGrose > 53%***

Ectopic precautions, repeat β‐hCG in 48 hrs

Repeat β‐hCG fell > 50%

β‐hCG > 1500 – 2000*

Repeat β‐hCG< 1500 – 2000*

Repeat β‐hCGfell 

> 50%

Repeat β‐hCG fell <50%or rose

Single β‐hCG > 1500 – 2000*and bleeding history consistent

with having passed POC’s

Obtain high‐level TVUS & serial bhCGs to differentiate between ectopic, early IUP, and retained 

POCs’ treat as indicated

Single β‐hCG > 1500 – 2000*and bleeding history not consistentwith having passed POC’s

Serial β‐hCG’s rising and

> 1500 – 2000*

NO IUP or EP seen on  TVUS

IUP seen on prior TVUS?Yes

No

Completed abortion; expectant management

Figure 2.  Evaluation of first‐trimester bleeding with no intrauterine pregnancy on ultrasound

ContinuedfromFigure1

* The β‐hCG level at which an intrauterine pregnancy should be seen on transvaginal ultrasound is referred to as the discriminatory zone and varies between 1500 – 2000 mIU depending on the machine and the sonographer.  ** β‐hCG needs to be followed to zero only if ectopic pregnancy has not been reliably excluded.  If a definitive diagnosis of completed miscarriage has been made there is no need to follow further β‐hCG levels. *** In a viable intrauterine pregnancy there is a 99% chance that the β‐hCG will rise by at least 53% in 48 hours.  In ectopic pregnancy, there is a 21% chance that the β‐hCG will rise by 53% in 48 hours.

RepeatTVUS;SeeTVUSinFigure1

Modified from Reproductive Health Access Project/October 2013    www.reproductiveaccess.org

First‐trimester Bleeding Algorithm

If patient stable repeat bHCG and once higher than 3000 and no IUP – uterine aspiration to rule 

out EPL and treat for EP if no IUP

Page 14: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

EPL Diagnosis, Counseling, and Management 

EPL – Making the diagnosis

Spontaneous abortionVaginal bleeding + IUP, <20 wks

threatened, inevitable,incomplete, complete

Embryonic demiseEmbryo with no cardiac activity

Anembryonic gestationGestational sac without

embryonic pole

Clinicaldiagnosis: Ultrasounddiagnosis:

Page 15: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Ultrasound Diagnosis of EPL:Anembryonic Gestation

Meansacdiameter>=21mm(20mm=0.5%falsepositive)ANDnofetalpole

Abdallah etal2011(Aug)UltrasoundObstet Gynecol

Ultrasound Diagnosis of EPL:Anembryonic gestation

Abdallah etal2011(AugandOct)UltrasoundObstet Gynecol

MSD(mm) Specificity False + Growthperday(wk) Specificity False+

8mm 64% 36% 0.2mm(1.4mm) 99% 1%

16mm 95.6% 4.4% 0.6mm(4.2mm) 90% 10%

20mm 99.5% 0.5% 1.0mm (7mm) 45% 55%

21mm 100% 0 1.2mm (8.4mm) 24% 76%

MSD,noYS,noembryo

MSD(mm) Specificity False + Growthperday(wk) Specificity False+

8mm 35.7% 64.3% 0.2mm 98.6 1.4

16mm 97.4% 2.6% 0.6mm 87.3 12.7

20mm 99.6% 0.4% 1.0mm 43.7 56.3

21mm 100% 0 1.2mm 25.2 74.8

MSD,+YS,noembryoGROWTH:

0mm/d=0False+

Page 16: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Ultrasound Diagnosis of EPL:Embryonic Demise

Fetalpole>=5.3ANDnocardiacactivity

Abdallah etal2011(Aug)UltrasoundObstet Gynecol

Ultrasound Diagnosis of EPL:Embryonic Demise

Abdallah etal2011(Aug&Oct)UltrasoundObstet Gynecol

CRL(mm) Specificity False + Growthperday(wk) Specificity False+

3mm 75% 25% 0.2mm(1.4mm) 100% 0%

4mm 91.7% 8.3% 0.6mm(4.2mm) 56.3% 63.7%

5mm 91.7% 8.3% 1.0mm (7mm) 0*

5.3mm 100% 0 1.2mm (8.4mm) 0% 0%

*16FP,0TN.37TP,1TN

Page 17: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Fetalpole– 7mm

MSD– 25mm

Radiologists in Ultrasound: Account for Margin of Error

Ultrasound MilestonesNormalIUPfindings

Whenshouldyouseeit?

Abnormalityiflandmarkisabsent

GestationalSac DiscriminatoryLevelβ =3,000?

CompletedEPLMultiplegestationEctopicpregnancy

Yolksac MSD>13‐16mm SuspiciousforEPL

Fetalpole MSD≥21mm(newrec25duetovariability)

Anembryonic gestation

Cardiacactivity CRL≥5.3mm(newrec7mm)

Embryonicdemise

Intervalgrowth(MSDorCRL)

1mm/day(over3‐7days)

ConfirmedEPL

Page 18: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

EPL Management

• Fouroptionsfortheclinicallystablepatient1. Aspirationw/general/deepsedation(operatingroom)2. Aspirationw/local/moderatesedation(office‐based)3. Medication(misoprostol+/‐ mifepristone)4. Expectantcare

• Allmethodsareeffective,withequivalentsafetyandpatientacceptability= clinicalequipoise

NSFG2004;Chen2007;Wieringa‐deWaard,2002;Zhang2005;Trinder 2006

EPL Management: A Preference‐Sensitive Decision

• Bestchoiceformanagementreflectsthewoman’svaluesandpreferences

• Patientshavestrong andwidelydivergentpreferences– ChallengesinrecruitmentforRCTs– Reporthighersatisfactionwhentreatedaccordingtopatient’spreference

Wieringa‐deWaard 2002;Dalton2006;Smith2006

Expectant Medication Office-based aspiration

Operating room

aspiration

Page 19: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

EPL Management:Patient Preferences

No ‘one best way’ to treat miscarriage that suits all individuals.

Expectant management is preferred over aspiration by 40-70% of women

When aspiration is indicated or preferred, the majority of women will choose an office-based procedure over one in the OR

Smith2006;Wieringa‐deWaard 2002;Dalton2006

Research on EPL Counseling

• Womenwantunbiasedandcomprehensivecounselingaboutoptionsforthispreference‐sensitivedecision.

• WomenperceivecommunicationduringEPLdiagnosisasacriticaltimetoinitiatediscussionsofmanagement.

• Womenareoftenweighingpersonalpriorities tomakedecisionsaboutEPLmanagement.

• Useofadecisionaidmayofferasystematiccounselingapproachforapatient‐centereddecision‐makingprocess.

Page 20: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Early Pregnancy Failure: Counseling

• Womenblamethemselves(“wasitthestress?”)

• Wonderifwillhappenagain

Patientcounselingshouldinclude:• Howcommonitis(encouragetotalktofriends)

• Reassurancethatitisbeyondhercontrolandunlikelytorecur(“Nothingcouldhavebeendonetopreventit.”)

• Acknowledge/validategrieving

• Noneedtowaittoattemptanotherpregnancy‐ oktotryafterresumptionofmenses(whenemotionallyready)

Importance of Options

“I think sometimes doctors have you do things or they prescribe things to you that are unnecessary.…I like the way it was presented to me…as options, and they were optional, they weren't necessary or required.”

Page 21: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

“They never said the word ‘miscarriage,’ I did.…I felt like I had to drag it out of them.…I said, ‘Okay, once we realize that I’m not mistaken with my dates and that this pregnancy should be 12 weeks and it is what you said it looks like, 5 weeks, so then what does that mean? What are the next steps?’”

Frustration with Ambiguous or Delayed News Delivery 

Patient Priorities

Pain Time Complications

Safety Bleeding Privacy

Anesthesia Past experience Finality

Page 22: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Provider Practice

Training Safety Data

EfficacyData

SystemResources

Staff Buy-in Assumptions

EPL Management Practices in the U.S.

0

5

10

15

20

25

30

35

40

45

50

Expectant Misoprostol Officeaspiration

OR

PercentofEPLproviders

Ob/Gyn CNM FP

AdaptedfromDalton2010

Page 23: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Patient Case: Counseling

• Mayawasdiagnosedwithanembryonicdemise.• Howdowecounselheraboutmanagementoptions?

Shared Decision‐Making

1. Providerpresentsallrelevantmedicalinformation.

2. Patientprovidesinformationaboutpersonalcircumstances,values,andpriorities.

3. Provideralsodiscussespreferenceswhileacknowledgingpersonalvaluesandbiases.

4. Decisionisreached.

InformationExchange

Deliberation

Negotiation & Agreement

Page 24: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

EPL Management 

Page 25: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Early Pregnancy Loss (EPL) Management

• Fouroptionsfortheclinicallystablepatient1. Aspirationw/general/deepsedation(operatingroom)2. Aspirationw/local/moderatesedation(office‐based)3. Medication(misoprostol+/‐ mifepristone)4. Expectant

• Allmethodsareeffective,withequivalentsafetyandpatientacceptability= clinicalequipoise

NSFG2004;Chen2007;Wieringa‐deWaard,2002;Zhang2005;Trinder 2006

Reference: Helping your patient to choose treatment for EPF

Misoprostol(800PV):Success:80%at1wk.Advantages:Privacy,availability,mostcanavoidsurgicaltx,?decreasedinfection,similarsatisfactionassurgicalDisadvantages:multiplevisits,30%require2nd dose,morepain,N/V&bleedingthansurgical

UterineAspiration:Success:~100%Advantages:2‐4hrs,highsuccessrate,lessblding &painDisadvantages:lessavailable,raresurgicalcomplications,?increasedinfection

Expectant:Success:60%at2wks.Advantages:Privacy,somecanavoidsurgicaltreatment,?decreasedinfectionDisadvantages:upto6wks tocomplete,morebleeding&morevisits,lesspatientsatisfaction

Page 26: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

EPL Management: A preference‐sensitive decision

• Bestchoiceformanagementreflectsthewoman’svaluesandpreferences

• Comprehensivemanagementoptionscanbeofferedinatypicalprimarycareoroutpatientsetting

Wieringa‐deWaard 2002;Dalton2006;Smith2006

Expectant Medication Office-based aspiration

Operating room

aspiration

Expectant Management

• “Watchfulwaiting”• Provensafetyupto8weeks• TypeofEPLaffectsexpectedefficacy• Highlyacceptabletopatientswithrealisticexpectationsabout:

Duration, Discomfort, and potential D&C

Page 27: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Expectant Management

Advantages• Non‐invasive• Bodynaturallyexpelsnon‐viablepregnancy

• Avoidsanesthesiaandsurgeryrisks

• Allowsforpatientprivacyandcontinuityofcare

Disadvantages• Unpredictableoutcomeandtimescale

• Processcanlastdaystoweeks

• Canhaveprolongedbleedingandcramping

• Despitewaiting,maystillneeduterineaspiration

Expectant Management

Contraindications• Uncertaindiagnosis• Suspectedgestationaltrophoblasticdisease

• Indicatedkaryotyping• Severehemorrhageorpain• Infection• IUDinplace

Same contraindications for medication management

Page 28: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Medication Management

• UseofmedicationsforactivemanagementofEPL• Misoprostol

– Stimulatesuterinecontractions&softenscervix– Inexpensive,easystorage

• Mifepristone– Anti‐progestinusedforpregnancytermination– Currentresearchdoesnotsupportroutineuseinnon‐viablepregnancies

Medication Management

Advantages• Highlycost‐effective• Non‐invasive• Safe• Canbehighlyeffective• Avoidsanesthesiaandsurgeryrisks

• Allowsforpatientprivacyandcontinuityofcare

Disadvantages• Increasedneedforanalgesicsandpaincontrol

• Maycauseheavierorlongerbleeding

• Maycauseshort‐termgastrointestinalandothersideeffects

• Maystillneeduterineaspiration

Page 29: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Practice Integration for Medication Management

• Evaluation– Exam,lab,orsono?

• Medications– DispensedinclinicorRx?

• 24hourcallservice• Back‐upplanforaspiration

– Emergentvs.non‐urgent

• Follow‐upplan

Misoprostol for EPL

Recommended inACOGPracticeBulletin

800mcgvaginally(PV) withoptionalrepeatdose>3hourslaterifnoinitialresponse

Page 30: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Medications for Symptoms and Side Effects

Cramping Ibuprofen600mgQ6hrs or800mgQ8hrs (orotherNSAID)

Severecrampingpainnotrelievedbyibuprofen

Hydrocodone/APAP5/500or5/325Q4‐6hrs prn

Nausea/vomiting Promethazine25mgQ4‐6hrsprn or otheranti‐emetic

Typical Follow‐Up

Phonecontact Callpatient1‐2daysafterfirstmisoprostoldosetoassessneedforseconddose.

In‐personvisit 1‐2weeksafterchoosingexpectantormedicationmanagementtoassess:1. Ifmiscarriageisnotcomplete– Is patient

interestedinalternatetreatments?2. Confirmcompletion (seebelow)

Confirmingcompletion

1. Clinicalhistoryconsistentwithcompletemiscarriageplusβ‐hCG declineof>50%ornegativeurinepregnancytest

2. Clinicalhistoryplusdisappearanceofintrauterinepregnancyontransvaginalultrasound

Page 31: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Aspiration for EPL

• Historicallydoneinoperatingroomundergeneralanesthesia

• Terminology:– Surgical“D&C”– SuctioncurettagewithMUAorEVA

Operating Room Aspiration

Advantages• Predictable• Offersfastestresolutionofmiscarriage

• Reduceddurationofbleeding

• Lowrisk(<5%)ofneedingfurthertreatment

• Canbeasleep

Disadvantages• Rarerisksassociatedwithinvasiveprocedureandgeneralanesthesia

• Morecostthanoffice‐basedprocedures

• Moretimeandphysicalexamsthanoffice‐basedprocedures

• Maybemorebleedingcomplicationsundergeneralanesthesiathaninoffice‐basedprocedures

Page 32: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Office‐based Aspiration

Advantages• Predictable• Offersfastestresolutionof

miscarriage• Reduceddurationofbleeding• Lowrisk(<5%)ofneeding

furthertreatment• Paincontrolwithlocalplusoral

orIVmeds

Disadvantages• Rarerisksofinvasiveprocedure• Lesspaincontroloptionsinsome

settings

Compared to OR management:• May allow improved patient access

and continuity of care • Improved privacy • Less patient and staff time• Resource and cost savings

EPL Management Principles

• Clinicalchecklistforcareoptions:– Cleardiagnosis– Patientisstable– Accesstophone&emergencycare– Paincontroloptionsavailable– Anticipatoryguidanceforbleeding,S/Sx infection– Rhstatus– Reliablefollow‐up

Page 33: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Patient Case: Management

• HowdowemanageMaya?• Chanceofsuccessforembryonicdemise:

– Expectant 1week(30%)2weeks(60%)6weeks(75%)

– Medical 1week(80%)– Aspiration InofficeorOR (97‐100%)

EPL: Patient‐Centered Care

1. Keepherinformedthroughoutthediagnosticwork‐up.2. Useclearandcompassionatelanguageindelivering

newsaboutmiscarriage.3. Bepreparedtodiscussmanagementoptionsat

diagnosis.4. Presentadvantagesanddisadvantagesofeach.5. Facilitaterecognitionofpatient’sprioritiesfor

managementdecision.6. Ensureappropriatefollow‐upandallowopportunityto

changemanagementdecision.

Page 34: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Patient Case: Management

• Mayachosetousemisoprostolathome.• Sheplacedthepillsvaginallyandbeganhavingcrampingandbleeding2hourslater.

• Herheavybleedinglasted4hours,andshenoticedoneparticularlylargeclot,thatmayhavehadtissueinit.

• Shestillhassomelightbleedingatherfollow‐upappointment,7dayslater.

Howdoweconfirmsuccessoftreatment?

EPL Management: Follow‐up

• Usebothhistoryandexamtoconfirmcompletion.– β‐HCGdrop>50%in48hoursornegativeUPT2weekslater

– Vaginalultrasound

• Treatthepatient,nottheultrasound.• Addressfertility.

– Contraceptionvsprenatalvitamins

• Offergriefcounselingfollow‐uporreferrals.

Page 35: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Vaginal Ultrasound

*ThicknessofendometriumNOTassociatedwithneedforfutureintervention

ACOG Practice Bulletin Early Pregnancy Loss (May 2015)

LevelA• 800mcgmisoprostolformedicalmanagement• Useofanticoagulantsdoesn’treduceriskLevelB• USpreferredmodalitytoverifyviableIUP• D&Cnotrequiredforthickstripeaftertreatmentifasymptomatic

• Rh‐ patientsshouldreceiveRhogamLevelC• Cansafelyaccommodatepreferences• Doxycyclinebeforesurgicalmanagement

Page 36: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Exploretheresourcepageandlinktothelearningmodule:

www.earlypregnancylossresources.org

Page 37: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Ectopic Pregnancy Management 

• Methotrexateisnotforeveryone

• NodifferenceinfutureIUPorectopicrates

• Single‐doselesseffectivethansalpingostomy (OR=0.38)

• 5%haverupturedespiteMTX

• Requiressignificantfollow‐up

Ectopic Treatment: MTX vs Surgery

Page 38: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Medical Treatment of EP

Methotrexate• AntimetabolitethatinterruptsDNAsynthesisinactivelydividingtissues

• Successfulin80‐95%• BetaHCGlevels>5000higherfailureratewithsingle‐dosetx (14%v.4%iflessthan5000)

• Single‐,two‐,multi‐doseregimens• Startwithsingle‐doseifb‐hcg <5000• Multi‐doseforcervicalorinterstitialectopics

Also:Inabilitytofollow‐up

ACOGPracticeBulletin#94

Medical Treatment of EP

ACOGPracticeBulletin#94

Page 39: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Treatment of EPSurgery• Ifhemodynamically unstable,patientdesiressurgery,contraindicationstoorfailedMTXtreatment

• Laparotomyorlaparoscopy• Salpingectomyorsalpingostomy

– Salpingectomyiftubecompromised– Similaroutcomesifnotcompromisedandothertubehealthy– Ifothertubeabsentorunhealthy– salpingostomy preferred

• 10%failurerateifsalpingostomy,requireb‐hcg followup

Expectantmanagement• IfbetaHCG<20088%resolvespontaneously• DecliningbetaHCG‐ thirdvaluelessthanfirst• Asymptomatic,informedconsent• Careful!

Conclusion

Page 40: Ectopic, Early Pregnancy Loss, or Normal Pregnancy?€¦ · Ectopic, Early Pregnancy Loss, or Normal Pregnancy? Diagnosis and Management of First‐Trimester Bleeding Jody Steinauer,

Conclusions

• Bleedinginearlypregnancyiscommon.• Takepossibilityofectopicpregnancyseriously!• Pregnancyofunknownlocationtakespatiencetosortout.

• PatientpreferenceiscriticalinmanagementofEPL.