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Miscarriage Management Training Initiative


Miscarriage Management Training Initiative Management of Early Pregnancy Loss Sarah Prager, MD Department of Obstetrics and Gynecology University of Washington – PowerPoint PPT presentation

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Title: Miscarriage Management Training Initiative

Miscarriage Management Training Initiative
Management of Early Pregnancy Loss
  • Sarah Prager, MD
  • Department of Obstetrics and GynecologyUniversity
    of Washington

MM-TI Goals
  • Move miscarriage management from the operating
    room to the outpatient setting
  • Train primary care clinicians and support staff
    in miscarriage management

  • Expand patient access to prompt, appropriate care
  • Improve patient safety
  • Improve patient satisfaction
  • Decrease costs

Challenges and Solutions
  • Difficult to influence physician practice
  • Target training during residency
  • Use a systems approach (include faculty,
    residents, key administrative personnel and
    support staff)

  • We are not talking about elective abortion
  • We are teaching and promoting miscarriage

MVA Safety and Efficacy Summary
  • MVA is simple
  • Easily incorporated into office setting
  • Expanded pain management options
  • Ultrasound as needed
  • Patient-provider interaction

Management of Early Pregnancy Loss
  • Objectives
  • Review etiologies of EPL
  • Review the three methods of EPL management
    Expectant Medical Surgical
  • Discuss benefits of outpatient EPL management

NomenclatureManagement of Early Pregnancy Loss
  • Early Pregnancy Loss (EPL)
  • Spontaneous Abortion (SAb)
  • Miscarriage

These all mean exactly the same thing!
BackgroundManagement of Early Pregnancy Loss
  • Spontaneous Abortion (SAb) most common
    complication of early pregnancy 820
    clinically recognized pregnancies 1326 all
  • 800,000 SABs each year in the US
  • 80 of SAbs occur in 1st trimester

  • 26 yo G2P1 presents to your office for a new ob
    visit. An ultrasound sows a CRL of 7mm but no
    cardiac activity.
  • She wants to know why this happened.

Risk FactorsManagement of Early Pregnancy Loss
  • Age
  • Prior SAb
  • Smoking
  • Alcohol
  • Caffeine (controversial)
  • Maternal BMI lt18.5 or gt25
  • Celiac disease (untreated)
  • Cocaine
  • NSAIDs
  • High gravidity
  • Fever
  • Low folate levels

EtiologyManagement of Early Pregnancy Loss
  • 33 anembryonic
  • 50 due to chromosomal abnormalities Autosomal
    trisomies 52 Monosomy X 19 Polyploidies
    22 Other 7
  • Host factors Structural abnormalities
    Maternal infection/endocrinopathy/coagulopathy
  • Unexplained

Normal Implantation DevelopmentManagement of
Early Pregnancy Loss
  • Implantation 5-7 days after fertilization
    Takes 72 hours Invasion of trophoblast into
  • Embryonic disc 1 wk post-implantation If
    no embryonic disc, trophoblast still grows, but
    no embryo (anembryonic pregnancy)
  • Embryonic disc embryonic/fetal pole

U/S Dating in Normal PregnancyManagement of
Early Pregnancy Loss
Mean Sac Diameter(mm) 30 OR Crown-Rump
Length(mm) 42
  • Gestational Age (days)

Clinical Presentation of EPLManagement of Early
Pregnancy Loss
  • Bleeding
  • Pain/cramping
  • Falling or abnormally rising ßhCG
  • Decreased symptoms of pregnancy
  • No symptoms at all!

Ultrasound Findings of EPLManagement of Early
Pregnancy Loss
  • Anembryonic Pregnancy No fetal pole with mean
    sac diam gt25 mm (transabdominal) OR gt18 mm
    (transvaginal) lt4 mm growth in 7 days (No
    yolk sac, with mean sac diameter gt10 mm)
  • Embryonic Demise No cardiac activity with CRL
    5 mm

Mishell DR, Comprehensive Gynecology 2007
  • Samantha and her partner request information on
    all the treatment options. You confirm the rest
    of her history.
  • PMH wisdom teeth removed
  • Ob Hx term SVD without complication
  • All NKDA

Management OptionsEarly Pregnancy Loss
  • Do Nothing Expectant management
  • Do Something Medical management
  • Do Surgery Surgical management

Sotiriadis A, Obstet Gynecol 2005Nanda K,
Cochrane Database Syst Rev 2006
Do NothingExpectant Management
  • Requirements for therapy lt13 weeks gestation
    Stable vital signs No evidence infection
  • What to expect Most expel within 1st 2 wks
    after diagnosis Prolonged follow-up may be
    needed Acceptable and safe to wait up to 4 wks

OutcomesDo Nothing Expectant Management
  • Overall success rate 81
  • Success rates vary by type of miscarriage(helpful
    to tailor counseling) Incomplete/inevitable
    abortion 91 Embryonic demise 76 Anembryonic
    pregnancies 66

Luise C, Ultrasound Obstet Gynecol 2002
What is Success?Definitions Used in Studies
  • 15 mm endometrial thickness (ET)3 days to 6
    weeks after diagnosis
  • No vaginal bleeding
  • Negative urine hCG

Problems with ET Cut-off
  • No clear rationale for this cut-off
  • Study of 80 women with successful medical
    abortion Mean ET at 24 hours 17.5 mm (7.629
    mm) At one week 15 with ET gt16 mm
  • Study of medical management after miscarriage
    86 success rate if use absence of gestational
    sac 51 success rate if use ET 15 mm

Harwood B, Contraception 2001Reynolds A, Eur. J
Obstet Gynecol Reproduct. Biol 2005
When to intervenefor Expectant Management?
  • Continued gestational sac
  • Clinical symptoms
  • Patient preference
  • Time (?)
  • Vaginal bleeding and positive UPT are possible
    for 24 weeks Poor measures of success

  • Samantha appears anxious about waiting and shares
    with you that she really needs to do something.

Do SomethingMedical Management
  • Misoprostol
  • Misoprostol Mifepristone
  • Misoprostol Methotrexate

No medical regimen for managementof EPL is FDA
Medical ManagementRequirement for Therapy
  • lt13 weeks gestation
  • Stable vital signs
  • No evidence of infection
  • No allergies to medications used
  • Adequate counseling and patient acceptance
    of side effects

  • Prostoglandin E1 analogue
  • FDA approved for prevention of gastric ulcers
  • Used off-label for many Ob/Gyn indications
    Labor induction Cervical ripening Medical
    abortion (with mifepristone) Prevention/treatmen
    t of postpartum hemorrhage
  • Can be administered by oral, buccal, sublingual,
    vaginal and rectal routes

Chen B, Clin Obstet Gynecol 2007
Why Misoprostol?
  • Do something while still avoiding surgery
  • Cost effective
  • Stable at room temperature
  • Readily available

Misoprostol Dosing RegimensEmbryonic Demise
Anembryonic Pregnancy
  • Study Dose Efficacy
  • Creinin 400 mcg po vs 800 pv 25 vs. 88
  • Ngoc 800 mcg po vs 800 pv 89 vs. 93 (NS)
  • Tang 600 mcg SL vs 600 pv 87.5 q 3 hrs x 3
    doses (SL had more side effects diarrhea, 70
    vs 27.5)
  • Phupong 600 mcg po x 1 vs. 82 vs 92 (NS) q 4
    hrs x 2 doses (Repeat dosing increased
    diarrhea, 40 vs 18)
  • Gilles 800 mcg pv saline- 83 vs 87
    (NS) moistened vs. dry

Creinin MD, Obstet Gynecol 1997 Ngoc NTN, Int.J
Gynaecol Obstet 2004 Tang OS, Hum Reproduct
2003 Phupong V, Contraception 2005 Gilles JM,
Am J Obstet Gynecol 2004
Misoprostol DosingIncomplete Abortion
  • Study N Dose vs. Results
  • Weeks et al, 05 317 600 oral d1,2 MVA 96.3 in
    12 wks
  • Moodliar et al, 05 94 600 vag DC 91.5
    in 1 wk
  • Zhang et al, 05 652 800 vag d1,3 DC 84 in 8
  • Coughlin et al, 04 131 400 oral x 2 78 1
    dose/ 92.4 ultimately
  • Ngai et al, 01 30 400 vag d1,3,5 observe 83 by
    day 15
  • Pang et al, 01 103 800 oral 65 in 24
    hrs 95 800 vaginal 61 in 24 hrs
  • Demetroulis, 01 40 800 vaginal DC 93 in
    8-10 hrs
  • Chung et al, 99 321 400 oral q4h DC 50
  • Chung et al, 97 225 400 oral tid DC 50
  • Chung et al, 95 141 400 oral q4h 50

also included missed abortions
Pooled OutcomesMedical Management
  • Success Rates
  • Placebo 1660
  • Single dose misoprostol 2588 400800 mcg
  • Repeat dose x 1 if incomplete 8088 at 24
  • Success rate depends on type of miscarriage
    100 with incomplete abortion 87 for all

Wood SL, Obstet Gynecol 2002 Bagratee JS, Hum
Reproduct 2004 Blohm F, BJOG Int J Obstet
Gynecol 2005
Serum Level ComparisonMisoprostol by Route of
Uterine Tone Over 5 HoursMisoprostol by Route of
Rectal p .006
Meckstroth, not yet published
Uterine Activity Over 5 HoursMisoprostol by
Route of Administration
Meckstroth, not yet published
Side Effects and ComplicationsMisoprostol vs.
  • N/V, Diarrhea No difference
  • Pain More pain and analgesics in one study
  • Hemoglobin Conc No difference
  • Infection 0 for placebo vs. .24.7 for
  • No benefit with repeat dosing within 34 hours
  • Improved outcome with 1 repeat dose at 24
    hours, if incomplete
  • 90 found medical management acceptable and
    would elect same treatment again

Wood SL, Obstet Gynecol 2002 Bagratee JS, Hum
Reproduct 2004 Blohm F, BJOG Int J Obstet
Gynecol 2005
Misoprostol Bottom LineMedical Management
  • 800 mcg pv (or buccal)
  • Repeat x 1 at 1224 hours, if incomplete
    Occasionally repeat more than once
  • Measure success as with expectant management
  • Intervene with surgical management if Continued
    gestational sac Clinical symptoms Patient
    preference Time (?)

Mifepristone and Misoprostol Medical Management
  • Mifepristone Progestin antagonist that binds
    to progestin receptor Used with elective
    medical abortion to destabilize implantation
    site Current evidence-based regimen 200 mg
    mifepristone 800 mcg misoprostol
  • Success rates for mifepristone misoprostol in
    EPL 5284 (observational trials,
    non-standard dose) 9093 (standard dose)
  • No direct comparison between misoprostol alone
    and mifepristone/misoprostol with standard
  • Mifepristone may help (data still pending)

Gronlund A, Acta Obstet Gynaecol 1998 Nielsen S,
Br J Obstet Gynaecol 1997 Niinimaki M,
Fertility Sterility 2006 Schreiber CA,
Contraception 2006
Methotrexate and Misoprostol Medical Management
  • Methotrexate Folic acid antagonist
    Cytotoxic to trophoblast
  • Used in medical management for ectopic pregnancy
  • Introduced in 1993 in combination with
    misoprostol to treat elective abortion medically
    Success rates up to 98 (misoprostol
    administered 7 days after methotrexate)
  • No data for use in early pregnancy loss

Creinin MD, Contraception 1993
  • Samantha opts to try misoprostol and returns to
    the office 7 days later for follow up. How do you
    assess whether or not her treatment is complete?

  • At her follow-up appointment, Samantha says that
    she had a period of heavy bleeding and is now
    spotting. Her cramping has resolved. She has
    noted a marked decrease in breast tenderness and
  • Her ultrasound shows a uniform endometrial stripe
    measuring 30mm in its greatest width.
  • Is she complete?

  • 32 yo G3P2 at 8 weeks by LMP was diagnosed with a
    fetal demise on her ultrasound and presents to
    your office after 2 weeks of expectant management
    stating that she wants to be done. She declines
    medical management and requests a DC.

  • What questions would you ask to see if she was a
    good candidate?

Surgical ManagementEarly Pregnancy Loss
  • Suction dilation and curettage (DC)
  • Who should have surgical management? Unstable
    Significant medical morbidity Infected Very
    heavy bleeding Anyone who WANTS immediate

Surgical ManagementEarly Pregnancy Loss
  • Convenient timing
  • Observed therapy
  • High success rates (almost 100)
  • Infection (1/200)
  • Perforation (1/2000)
  • Cervical trauma
  • Uterine synechiae(very rare)

Infection ProphylaxisSurgical Management
  • Periabortal antibiotics ? infection risk 42
  • No strong evidence on what to use
  • Doxycycline (214 doses)
  • Metronidazole Bacterial vaginosis
    Trichomoniasis Suspicious discharge

Sawaya GF, Obstet Gynecol 1996 Prieto JA, Obstet
Gynecol 1995
Comparison of Outcome by MethodManagement of
Early Pregnancy Loss
  • Factor Comparison of Methods
  • Success rate Surgical gt Medical Medical
  • Resolution Surgical gt Medical gt Expectant
    within 48 hrs
  • Infection risk Expectant Medical

Number differed by highly variable success rates
reported for expectant management
Nanda K, Cochrane Database Syst Rev 2006 Nielsen
S, Br J Obstet Gynaecol 1999 Shelly JM, Aust.
NZ J Obstet Gynaecol 2005 Sotiriadis A, Obstet
Gynecol 2005 Tinder J, (MIST) BMJ, 2006
Patient SatisfactionManagement of Early
Pregnancy Loss
  • Meta-analysis shows studies report high
    satisfaction with medical management
  • Caution Few studies looked at satisfaction
  • Satisfaction depended on choice If women
    randomized 55-74 satisfied If women chose
    84-88 satisfied Both were independent of
  • Unsuccessful expectant resulting in surgical
    showed most profound anxiety and depression

Sotiriadis 2005
Zhang, NEJM 2005
Cost AnalysisManagement of Early Pregnancy Loss
  • Medical management most cost effective 2
    studies Misoprostol vs. expectant vs. surgical
    1000 vs. 1172 vs. 2007
  • Expectant management most cost effective MIST
    trial Expectant vs. medical vs. surgical
    1086 vs. 1410 vs. 1585

Doyle NM, Obstet. Gynecol 2004 You JH, Hum
Reprod 2005 Petrou S, BJOG 2006
  • Refer to OR?
  • Manage with MVA?
  • The clinic schedule is packeddoes this have to
    be done today?

Where to perform?Surgical Management
  • Women with SAb in Canada 92.5 presenting to
    hospital have DC 51 presenting to family
    physician have DC
  • Manual vacuum aspiration (MVA) in outpatient
    setting can ? hospital costs by 41

Weibe E, Fam Med 1998 Finer LB, Perspect Sexu
Reproduct Health 2003 Blumenthal PD, Int J
Gynaecol Obstet 1994
AdvantagesMoving Rx from OR to Outpatient Setting
  • Avoid repeated exams that often occur in
  • Simplify scheduling and reduce wait time
    Average OR waiting time in UK-based study 14
    hours, with 42 of women not satisfied
  • Save resources
  • Avoid cumbersome OR protocols Prolonged NPO
    requirements and discharge criteria

Demetroulis 2001 Lee and Slade 1996
AdvantagesMoving Rx from OR to Outpatient Setting
  • Office affords more treatment options Vacuum
    aspiration or misoprostol Pain management
  • Improved patient autonomy and privacy
  • Convenience
  • Personalized care

Lee and Slade 1996
Moving Incomplete Abortion to Outpatient
SettingJohns Hopkins Study
  • Methods
  • N 35, incomplete 1st-trimester abortion
  • Treatment comparison

Manual Conventional vacuum care aspiration
(suction (MVA) curretage) LD OR
Procedure Setting
Blumenthal and Remsburg 1994
Moving Incomplete Abortion to Outpatient
SettingJohns Hopkins Study
  • Results
  • ? Anesthesia requirements
  • ? Overall hospital stay, from 19 6 hours
  • ? Patient waiting time by 52
  • ? Procedure time, from 33 19 minutes
  • ? Costs per case 1,404 in OR 827 in
    LD 200 or less in ER

Blumenthal 1994
Use Outpatient Management Cautiously in Women
  • Uterine anomalies
  • Coagulation problems
  • Active pelvic infection
  • Extreme anxiety
  • Any condition causing patient to be medically

What Is a Manual Vacuum Aspirator?
  • Locking valve
  • Portable and reusable
  • Equivalent to electric pump
  • Efficacy same as electric vacuum (9899)
  • Semi-flexible plastic cannula

Creinin MD, et al. Obstet Gynecol Surv. 2001.
Goldberg AB, et al. Obstet Gynecol. 2004. Hemlin
J, et al. Acta Obstet Gynecol Scand. 2001.
ComparisonEVA to MVA
Vacuum Electric pump Manual aspirator
Noise Variable Quiet
Portable Not easily Yes
Cannula 416 mm 412 mm
Capacity 3501,200 cc 60 cc
Suction Constant Decreases to 80 (50 mL) as aspirator fills
Dean G, et al. Contraception. 2003.
Clinical Indications for MVA
  • Uterine evacuation in the first trimester
  • Induced abortion
  • Spontaneous abortion
  • Incomplete medication abortion
  • Uterine sampling
  • Post-abortal hematometra
  • Hemorrhage

Creinin MD, et al. Obstet Gynecol Surv. 2001.
Edwards J, Creinin MD. Curr Probl Obstet Gynecol
Fertil.1997. Castleman LD et al. Contraception.
2006 MVA Label. Ipas. 2007.
MVA Instruments
Steps for Performing MVA
A step-by-step poster is available from the
manufacturer to guide clinicians through the
procedure is in your packet - Performing
Manual Vacuum Aspiration (MVA). . .
Complications with MVA
  • Very rare
  • Same as EVA
  • May include Incomplete evacuation Uterine
    or cervical injury Infection Hemorrhage
    Vagal reaction

MVA Label. Ipas. 2004.
MVA vs. EVA Complication Rates
  • Methods
  • Vacuum aspiration for abortion up to 10 wks LMP
  • Retrospective cohort analysis
  • Choice of method (MVA vs. EVA) up to physician
  • n 1,002 for MVA n 724 for EVA
  • Charts reviewed for complications

Goldberg AB, et al. Obstet Gynecol. 2004.
MVA vs. EVA Complication Rates (continued)
Elective not spontaneous studies
Goldberg AB, et al. Obstet Gynecol. 2004.
MVA vs. EVA Complication Rates (continued)
Goldberg AB, et al. Obstet Gynecol. 2004.
MVA and POC Study
  • In group overall
  • n 1,726, up to 10 weeks LMP
  • Complication rates between MVA and EVA
  • 37 patients at lt 6 weeks gestation
  • In 35 of 37, provider chose MVA
  • No re-aspirations needed in patients lt 6 weeks

Goldberg AB, et al. Obstet Gynecol. 2004.
MVA and POC Study (continued)
Significantly more re-aspirations for inability
to accurately identify the pregnancy occurred in
electric group.
Goldberg AB et al. Obstet Gynecol, 2004
Goldberg AB, et al. Obstet Gynecol. 2004.
Early Abortion with MVA Study
  • Methods
  • 2,399 MVA procedures, lt 6 weeks LMP
  • Meticulous inspection of POC immediately after
  • Results
  • 99.2 effective in terminating pregnancy
  • 6 repeat aspirations (0.25)
  • 14 ectopic pregnancies (0.6) diagnosed and

Edwards J, Creinin MD. Curr Probl OIbstet Gynecol
Fertil. 1997.
Products of Conception (POC)
  • Procedure is complete when POC are identified

Edwards J, et al. Am J Obstet Gynecol.
1997. MacIsaac L, et al. Am J Obstet Gynecol.
Patient Satisfaction
  • Both EVA and MVA groups were highly satisfied
  • No differences in
  • Pain
  • Anxiety
  • Bleeding
  • Acceptability
  • Satisfaction
  • More EVA patients were bothered by noise

Bird ST, et al. Contraception. 2003. Dean G, et
al. Contraception. 2003. Edelman A, et al. Am J
Obstet Gynecol. 2001.
MVA Safety and Efficacy Summary
  • MVA is simple
  • Easily incorporated into office setting
  • Training/Practice Issues
  • Expanding pain management options
  • Ultrasound as needed
  • No sharp curettage
  • Patient-provider interaction
  • Instrument processing for multiple use (new

  • Rebecca is wanting to have an office procedure,
    but she is concerned about the pain.
  • What can you tell her about pain management in
    the office?

MVA and Pain
  • Pain is made worse by
  • Fearfulness
  • Anxiety
  • Depression

Belanger E, et al. Pain. 1989. Smith GM, et al.
Am J Obstet Gynecol. 1979. Hansen GR, Streltzer
J. Emerg Med Clin N Am. 2005.
Effective Pain Management
  • Respectful, informed, and supportive staff
  • Warm, friendly environment
  • Gentle operative technique
  • Womens involvement
  • Effective pain medications

Pain Management Techniques
  • With addition of
  • Focused breathing 76
  • Visualization 31
  • Localized massage 14

General or nitrous
Local IV
Lichtengerg ES, et al. Contraception. 2001. Good
M, et al. Pain Manag Nurs. 2002.
Efficacy of Ancillary Anesthesia
  • Importance of psychological preparation and
  • Music as analgesia for abortion patients
    receiving paracervical block
  • 85 who wore headphones rated pain as 0,
    compared with 52 of controls
  • Verbicaine (Vocal Local)/Distraction Therapy

Shapiro AG, Cohen H. Contraception. 1975.
Stubblefield PG.Suppl Int J Gynecol Obstet. 1989.
Paracervical Block
Deep Injection
Regular Injection
Castleman L, Mann C. 2002. Maltzer DS, et al.
Sharp Curettage and Pain
  • Often requires increased dilatation
  • Often painful
  • More difficult to reduce anesthesia

Forna F, Gulmezoglu AM. Cochrane Library. 2002.
Sharp Curettage and MVA
  • Generally not indicated
  • Not routinely recommended after MVA

WHO. 2003
Ultrasound and MVA
  • Not required for MVA
  • Used by some providers routinely
  • Use contingent on provider preference and

Word Health Organization. 2003.
Counseling for MVA
  • Effective counseling occurs before, during, and
    after the procedure
  • Prepare women for procedure-related effects
  • Address womens concerns about future desired

Breitbart V, Repass DC. J Am Med Womens Assoc.
2000. Hogue CJ, et al. Epidemiol Rev. 1982
Steward FH, et al. 2004. Hyman AG, Castleman L.
  • Rebecca is scheduled for a uterine aspiration
    with MVA procedure during the next procedure
  • The procedure is uncomplicated and her questions
  • Can I get pregnant right away?
  • Am I at risk for another miscarriage?

Future Miscarriage Risk
Counseling for MVA (continued)
Patient satisfaction with care
Quality of counseling
Picker Institute. 1999.
Postmiscarriage CareManagement of Early
Pregnancy Loss
  • Rhogam at time of diagnosis or surgery
  • Pelvic rest for 2 weeks
  • No evidence for delaying conception
  • Initiate contraception upon completion of
    procedure (even IUDs!)
  • Expect light-moderate bleeding for 2 weeks
  • Menses return after 6 weeks
  • Negative ßhCG values after 24 weeks
  • Appropriate grief counseling

Goldstein R, Am J Obstet. Gynecol 2002 Wyss P, J
Perinat Med 1994 Grimes D, Cochrane Database
Syst Rev 2000
When Women Should Contact Clinician
  • Heavy bleeding with dizziness, lightheadedness
  • Worsening pain not relieved with medication
  • Flu-like symptoms lasting gt24 hours
  • Fever or chills
  • Syncope
  • Any questions

For more information on EPL
  • Association of Reproductive Health Professionals
    (ARHP) archived webinar Options for Early
    Pregnancy Loss MVA and Medication Management
  • www.arhp.org/healthcareproviders/cme/webcme/index
  • Ipas WomanCare Kit for Miscarriage Management
  • www.ipaswomancare.com

  • Questions
  • Papaya Demonstration to Follow
  • pragers_at_u.washington.edu

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