ARHP Management of Early Pregnancy Failures in the Outpatient Setting Emily Godfrey MD MPH Michelle Forcier MD MPH ARHP National Conference 2006 Pre-Conference.

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Management of Early Pregnancy Failures in the

Outpatient SettingEmily Godfrey MD MPH

Michelle Forcier MD MPHARHP National Conference 2006

Pre-Conference Workshop

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Objectives

• Appreciate the historical context regarding terminology, diagnosis, and management of early pregnancy failure and how it has evolved

• Recognize the various presentations and classifications of early pregnancy failure

• List new and different treatment options currently available for early pregnancy failure

• Describe new data suggesting a role for misoprostol in the management of early pregnancy failure

• Describe the current standard treatment using MVA for early pregnancy failure

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Early Pregnancy Failures

• Incidence:– 15-20% clinically recognized pregnancies– Estimated 30% if non-clinically recognized

pregnancies are included*

• 80% occur in first trimester

* Wilcox NEJM 1988

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Types of Early Pregnancy Failure• Threatened • Inevitable*

– Uterine cramping– Dilated cervical os

• Incomplete*– Inevitable with passage of some POCs

• Missed*– Closed os– Uterine cramping

• Septic• Complete

– No uterine cramping– Cervical os closed– Complete passage of tissue

* Early Pregnancy Failure

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History of the Management of EPF

• Pre 1880– Less is better

• Post 1880– Development of curette– Reduction of hemorrhage– Reduction of infection– Intervention advocated because high rates of

infection accompanying illegal abortion

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Management of EPF

• Today– D & C still remains the standard of care despite decreased incidence of

septic abortion– Potential complications

• Risk of anesthesia• Uterine perforation• Intrauterine adhesions• Cervical trauma• Pelvic Pain• Increased risk of ectopic pregnancy (subsequent)

• Alternative treatment options – Manual vacuum aspiration– Medical management with prostaglandin analogues (i.e. Misoprostol)* – Expectant management

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Expectant management

• In the setting of incomplete abortion expectant management is successful 82-96% of the time

• Average time to completion is 9 days• Success rate is less for embryonic death or

anembryonic gestations (missed abortions) (25-76%)• First trimester miscarriages may be expectantly

managed indefinitely if without hemorrhage or infections

Griebel AFP 2005

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Success of expectant management

Group N Complete day 7

Complete day 14

Success day 49

Incomplete 221 117 (53%) 185 (84%) 201 (91%)

Missed 138 41 (30%) 81 (59%) 105 (76%)

Anembryonic 92 23 (25%) 48 (52%) 61 (66%)

TOTAL 451 181 (40%) 314 (70%) 367 (81%)

Luise C. BMJ 2002

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Misoprostol (Cytotec)

• Prostaglandin E1• FDA approved for

prevention and treatment of gastric and duodenal ulcers

• Heat stable (does not need refrigeration)

• Inexpensive• Widely available• Oral preparation

– 100 g (non-scored) & 200 g (scored) tablets

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Misoprostol: Physiologic Effects

Uterine: Stimulate contractions

Cervical Softens and primes cervix

Gastrointestinal: Prevents/treats ulcersNauseaVomitingDiarrhea

Systemic: Fever

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Routes of Administration

Oral

Vaginal

Buccal

Sublingual

Rectal

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Vaginal Use

• Manufactured and approved for oral use only

• Greater effects on reproductive tract with vaginal dosing*

• Decreased gastrointestinal side effects with vaginal dosing*

*Danielsson 1999Creinin 1993

Toppozada 1997

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Buccal & Sublingual Use

• Mostly been studied with the use of induced medical abortion

• Sublingual has faster absorption than buccal*• Buccal as effective as vaginal in induced

medical abortion up to 56 days’ gestation• Sublingual as effective as vaginal misoprostol

in induced medical abortion up to 63 days’ gestation

*Schaff, EA et al. 2005*Tang, OS et al 2006

Middleton, T et al 2005

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Surgical options

• Sharp curettage (D and C) no longer an acceptable option due to higher complication rates

• Vacuum aspiration includes manual vacuum aspiration (MVA) vs. electrical pump aspiration

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MVA Instruments and Supplies

• Inexpensive• Small • Portable • Quiet• Specimen likely

to be intact• May require repeated reloading of suction

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Literature Review

• Standard dosage and dosing intervals have not been well established

• Studies difficult to compare– Various patient populations and dosing regimens– Different routes of administration– Varying definitions of success

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Incomplete and Missed AB

• Demetroulis et al, 2001• Prospective RCT• 80 women w/missed AB or incomplete AB• Misoprostol vs. Surgical evacuation • Results:

– 82.5% successful in Misoprostol group– Failure rate higher for Missed AB patients (23% v.

7%)

Demetroulis. Human Reproduction, 2001

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Missed Abortion

• Wood et al, 2002• Double blind randomized controlled trial (Type I

study)• 50 women

– Ultrasound dx of missed ab– Absence of cramping and bleeding– Less than 12 weeks uterine size

• 800 g misoprostol – up to 2 doses– Vaginal versus placebo

• Follow-up– 24 hours, 48 hours, 1 week

Wood and Brain, Obstet Gynecol 2002

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Missed Abortion

• Misoprostol– 15 of 25 completed after first dose @ 24h– 21 of 25 completed after second dose @ 48h– 2 had on-going bleeding– 1 had retained tissue

• Placebo– 1 of 25 completed after @ 48h– 4 of 25 completed @ 1 week

• No significant change in hemoglobin levels

Wood and Brain, Obstet Gynecol 2002

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Comparison of surgical with medical management: EPF

• Zhang et al, 2005• Prospective, RCT • 652 w/ 1st trimester pregnancy failure

– Anembryonic– Embyronic or fetal death– Incomplete– Inevitable

• Misoprostol 800 g, repeat day 3 – Vaginal versus surgical evacuation

• Complications– Surgical treatment for the miso group– Repeat surgical procedure within 30 days

Zhang. NEJM 2005

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Comparison of surgical with medical management: EPF

• Results– Misoprostol Group

• 71% complete by Day 3• 84% complete by Day 8

– Treatment Failure• 16% Misoprostol group• 3% Surgical group

• Conclusions– Treatment of EPF with Miso is safe and works about 84%

of the time

Zhang. NEJM 2005

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Missed Abortion Using Sublingual Misoprostol

• Tang, et al, 2006• Prospective randomized controlled trial • 180 women

– Ultrasound dx of missed ab – Absence of cramping and bleeding– Less than 13 weeks uterine size

• 600 g sublingual misoprostol Q 3 hours x 3 vs 400 g sublingual misoprostol daily x 1 week

• Results at 1 week– 92% completed in SL x 3 group– 93% complete in SL x 3 + daily group

• Greater side effects reported in the SL x 3 + daily group

Tang. Hum Reprod 2006

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Early Pregnancy Failure Treatment Using Mifepristone/Misoprostol

• Trinder, et al, 2006• Prospective randomized controlled trial • Miscarriage Treatment Trial (MIST)• 1200 women

– Less than 13 weeks gestation – Incomplete miscarriage, Anembryonic, Missed abortion

• Expectant vs. Medical vs. Surgical• Incomplete: 800 miso only vaginal• Anembyronic/Missed: 200 mife + 800 miso 24-48 hr• Primary outcome: infection within 14 days• Secondary outcome: efficacy (no D & C within 8 weeks)

Tinder. BMJ 2006

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Early Pregnancy Failure Treatment Using Mifepristone/Misoprostol

• Results– Gynecological Infection

• No difference between the groups– Anembyronic/Missed

• 6% Surgical group• 38% Medical group• 50% Expectant group

• Conclusions– Infection rates did not differ between groups– Surgical Management is more treatment option than

medical or expectant managementTinder. BMJ 2006

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Meta-analysis of Expectant, Surgical and Medical

• Comparison of expectant, medical and surgical treatment of 1st trimester spontaneous abortion

• 28 studies eligible for analysis

• Medical v. expectant: expectant was 39% successful.

• Medical 3 times more likely to be successful

Sotiriadis. Obstet Gynecol 2005

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• Surgical v. expectant: expectant was 79%• Surgical more likely to be successful than

expectant• Surgical v. medical: surgical was 1.5 times

more successful than medical• Pt satisfaction did not differ significantly

between surgical and medical, although trend favored medical management

Sotiriadis, Obstet Gynecol 2005

Meta-analysis of Expectant, Surgical and Medical, cont.

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Conclusion

• Early pregnancy failure is common • Expectant, medical and surgical management can

be done safely in an outpatient setting• Study findings vary because of lack of uniformity of

study populations• Patients should be counseled accordingly so they

can choose best treatment option

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CASES

Discussions about Outpatient Management of Miscarriage

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Case 1

You see a 18-year old woman, G2P1001, whose last period was 8 weeks ago. She had a positive home pregnancy test 3 weeks ago. Her first prenatal appointment is scheduled with another provider. She has not had an ultrasound during this pregnancy.

Three days ago, she began to spot. Today, her bleeding has increased, like a very heavy period with some clots. She began cramping last night and now reports that the cramping is severe. She comes to your clinic today for assessment and treatment if required.

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Case 1

Her medical history includes a spontaneous vaginal delivery 2002. She is otherwise healthy. On exam, she appears comfortable and is able to walk around the room and talk easily. Her vital signs:BP 110/70, Pulse 90, Temp 97.8

At this point, how would you proceed with evaluation?

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Case 1

The examination reveals the following– Abdomen: soft, nontender– Vaginal vault: scant amount of blood, consistent with a

menses– Cervix: os open, tissue at os noted – Bimanual exam: uterus enlarged, approx. 8 weeks size,

nontender

• Her hemoglobin is 12.2.• Urine pregnancy test: positive

What tests do you think you should order now?

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Case 1

The ultrasound reveals an intrauterine gestational sac, and thickened endometrial stripe.

What is the diagnosis?

What are the treatment options available for this patient?

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Case 1 Key ConceptsIncomplete/Inevitable Abortion

• 600-800 mcg effective dose without too many side effects

• May give vaginally, orally, sublingual (not well studied)

• May repeat

• More effective for incomplete abortions than for missed abortions

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Case 2

41 yo G1P1 presents to the Clinic for her first prenatal visit in a very desired pregnancy. Her LMP was 10 weeks ago and she is certain of her dates. The pregnancy has been uncomplicated except for a small amount a bleeding she had about 1 week ago. You evaluate the patient and finds that her BM exam is consistent with a 7 wk IUP, os is closed.

What other information might you be interested in knowing about? What might you order to get a diagnosis?

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Case 2

Fortunately, your Clinic has a portable ultrasound, and you are able to supervise the resident with a vaginal probe ultrasound. You see a well-circumscribed, though empty gestational sac.

What are your differential diagnoses? What do you tell the patient?

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Case 2

The patient returns 5 days later with further spotting and cramping. A 2nd serum β-hCG is done, as well as a repeat ultrasound. The ultrasound now shows a large irregular shaped gestational sac. The serum β-hCG level has dropped.

What is your assessment?

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Case 2

The patient decides to opt for medical treatment.

What regimen do you use?

How do you advise her? What can she expect?

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Case 2 Key ConceptsAnembryonic Pregnancy

• Consider the emotional aspects of miscarriage

• Element of choice in patient satisfaction

• Effectiveness of medication methods as well as surgical methods

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Case 3

26 yo G2P2002 LMP uncertain because of irregular periods well known to you presents to your office with spotting x 4 days. She denies any pain. Her urine pregnancy test is positive, her cervical os closed. Her uterus is retroverted. She has a remote history of Chlamydia infection about 10 years ago.

What is your differential diagnosis? What tests would you order now?

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Case 3

You perform an ultrasound and you see small echolucent area, which could be a small gestational sac or a pseudosac.

What should you do now?

What is your diagnosis? What are you options for treatment?

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Case 3 Key ConceptsEctopic Pregnancy

• Ectopic vs early pregnancy may be hard to differentiate

• Methotrexate an option for early & stable patients

• MVA can help evaluate POC in clinic, guiding diagnosis & referral decisions

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MVA for Miscarriage Management in the Out-Patient Setting

ARHP WorkshopSeptember 6, 2006

Emily Godfrey, MD MPHMichelle Forcier, MD MPH

ARHP

Updates in Miscarriage Management

• To discuss issues in evaluation & management of early miscarriage

• To discuss the evidence behind the options for miscarriage management

• To review manual vacuum aspiration (MVA) for miscarriage management– Summarize the safety and efficacy of MVA– Discuss pain management in out-patient settings– Discuss moving miscarriage management out of OR

• To demonstrate technique or update your skills in MVA for uterine evacuation

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What is MVA?

Goldberg 2004; Creinin 2001; Hemlin 2001

•Manual vacuum aspirator

•Semi-flexible plastic cannula

•Portable & reusable

•Efficacy = electric vacuum (98-99%)

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Indications for MVA

• Uterine evacuation first trimester– Induced abortion– Spontaneous abortion or early pregnancy

failure (EPF)

• Complications management– Incomplete medical abortion– Post-abortal hematometra

• Uterine sampling– Endometrial biopsy

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MVA Safety & Efficacy

• Hale 1979 (MVA in 1st trimester, gynecology office, Hawaii)• Edwards 1997 (MVA at < 6 weeks gestation, women’s clinic,

Texas)• Westfall 1998 (MVA in 1st trimester, family practice office,

Colorado)• Hemlin 2001 (EVA vs. MVA at < 8 weeks gestation, hospital

operating room, Sweden)• Paul 2002 (EVA and MVA at < 6 weeks, Planned Parenthood,

Massachusetts)• Goldberg 2004 (EVA vs. MVA up to 10 weeks, University of

California, San Francisco)

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Early Abortion with MVA

Author Date N Gestational Age

Efficacy

Paul et al. 2002 1,132 (MVA+EVA) <6 98%

Edwards & Carson

1997 1,530 MVA <6 99%

Edwards & Creinin

1997 2,399 MVA <6 99%

Hemlin & Moller 2001 91 MVA <8 98%

Laufe 1977 12,888 “About 6” 98%

Adapted from Baird and Flinn 2001

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MVA vs EVA

EVA

• Electric pump• Costly but longer life• Variable noise level• Not easily portable• Capacity: 350-1,200 cc• Constant suction• Fragmentation of POCs

MVA

• Manual aspirator• Inexpensive• Quiet• Portable• Capacity: 60 cc• Suction decreases as

aspirator fills• POCs likely intact

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Complications with MVA

• Rare

• Same as for EVA– Incomplete evacuation

– Uterine or cervical injury

– Infection

– Hemorrhage

– Vaso-vagal reaction

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MVA for Miscarriages

• Aspiration recommended if– Prolonged or excessive bleeding– Signs of infection– Patient preference

• Advantages– Portable & low cost device– Suitable for outpatient services– Applications to variety of settings (primary care,

ob/gyn office, ER)

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Patient Satisfaction

• Both EVA and MVA groups highly satisfied

• No difference reported in – Pain– Anxiety– Bleeding– Acceptability & satisfaction

• More EVA patients bothered by noise (p=0.03)

Bird et al. 2003, Dean et al. 2003, Edelman et al. 2001

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MVA Instruments

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MVA: Key Benefits• Safety & efficacy equivalent to EVA •Portable•Low tech•Low-cost•Small and quiet

Significant implications for incorporating services into the office settingDalton and Castleman 2002; Goldberg et al. 2004

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MVA: Essentials for Providers

• Pain management for awake patient

• Counseling & rapport

• Ultrasound

• Identifying products of conception

• Instrument processing

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Video of MVA Procedure

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MVA Video- Important Points?

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Video – Important Points

• Actual patient from local outpatient clinic

• Ibuprofen and paracervical block only

• In procedure room time ~10-15 minutes

• Actual time for uterine evacuation ~1-2 minutes

• Recovery time ~30 minutes

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Pain ManagementIn the

Out Patient Setting

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Pain Management in Outpatient Settings

• Staff often express concern that uterine evacuation requires general or conscious sedation

• Many uterine evacuations done under paracervical (local) block

• Definite ways you can improve pain management in your outpatient setting

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Pain Management Techniques

Local + IV 32%

General or nitrous 10%

Local 58%

With Addition Of:

•Focused breathing: 76%•Visualization: 31%•Localized massage: 14%

Lichtenberg 2001

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Importance of Pain Management

• Most common concern expressed by patient• Highly linked to patient satisfaction• Whose perspective?

– Patients– Clinician– Counselor/bedside assistant

• What are we trying to do?– Minimize risk / maximize benefit– Take away all pain/all feeling– Get through it

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Effective pain management

• What worsens pain?– Pre-procedure fearfulness– Anxiety– Depression

• What reduces pain?– Respectful, informed and supportive staff– Warm and friendly environment– Gentle operative technique– Women’s involvement & sense of control– Effective pain medications

Belanger 1989; Smith 1979

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Other Influences on Pain

• Provider– The clinician has a profound effect on pain score,

independent of anesthetic (Rawling 1998 and 2001)

• Patient’s sense of control– “The idea that I could manage the miscarriage

myself with guidance available whenever I needed it…I felt calmer, more confident, less medicated and out of control.”(Wiebe 1999)

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Role Play- Patient Centered Care

• 23 yro G1P0 miscarrying at EGA 8 weeks

• Very desired pregnancy

• Bleeding and cramping x 24 hrs

• No fetal heart activity & CRL only measuring 5 weeks

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Paracervical Block

Maltzer 1999; Castleman 2002

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Options for Anesthesia

• Local• Conscious sedation• Other

– Psychological

• Information, preparation & support – Music as analgesia

• 85% abortion patients wearing headphones rated pain as “0” compared to 52% controls

– DistractionStubblefield 1989

Shapiro 1974

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Curettage and Pain

• Using the curette often requires increased dilatation

• Curetting hurts! Makes reducing anesthesia more difficult

Sharp curettage generally not indicated & not routinely recommended following MVA

Forna 2002

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In Conclusion . . .

• No pain panacea– Affirm the patient’s existing viewpoint wherever possible– Avoid glib reassurances– Advise the patient that her fears are widely shared– Help the patient to differentiate between emotional and

physical pain

• Women want to be involved in developing their pain management plan

• Curette check hurts - usually not needed

• Pre-procedure preparation & psychological support reduce anxiety & improve overall experience

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Other Clinical Benefits of MVA

POCS are easier to visualize & inspect

– Often more intact

– Easier detection of early EGA • Fewer re-aspirations in MVA vs EVA group

(Goldberg 2004)

– Can still send to pathology for genetics

Goldberg 2004; MacIsaac 2000; Edwards 1997

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MVA POC Check: Benefits for EPL

Creinin and Edwards 1997

Electric Suction Machine MVA Aspirator

What is that?

There it is!

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MOVING OUT OF THE OPERATING ROOM

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Uterine evacuation- Why the OR?

• OR was necessary when emptying the uterus was an emergency– Abortion was illegal – Antibiotics were not available– Access to blood transfusion limited

“Puerperal (childbed) fever was the scourge of nineteenth century obstetrics and abortion.” Joffe 1999

• Today, out patient care safe, convenient, cost effective option for stable patients

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OR to Out Patient Clinic – Benefits

• Simplify scheduling• Reduce waiting and repeat exams

• Avoid cumbersome OR protocols • Prolonged NPO requirements & discharge criteria

• Save resources• Outpatient saves materials required,

costs/charges, personnel

Demetroulis 2001

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Out Patient - Benefits to your Patients

Why some patients want MVA

• Control/autonomy while awake during procedure• Convenience & time

– Single appointment – Rapid recovery time

• Personalized care by single provider• Improved patient education, attitudes,

accommodations in out patient setting (Lee 1996)

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Moving Miscarriage Management to Outpatient Setting – Johns Hopkins Study

Results

– Decreased anesthesia requirements– Decreased overall hospital stay from 19 to 6 hours– Decreased patient waiting time by 52%– Decreased procedure time from 33 to19 minutes– Decreased costs per case

$1404 in OR$827 in L&D$200 or less in ER

Blumenthal 1994

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Moving Abortion to an Outpatient Clinic - Bellevue Hospital

Methods• Compared costs, staff, complications: OR vs. Outpatient• N = 967; Patients undergoing first trimester pregnancy

termination in outpatient procedure room (2000-2002)

Results

Bellevue Hospital Improvement Reports, Masch 2002

Outpatient MVA

Operating

Room

Cost per Procedure

$167 $1,435

Staff 2 5

No reported complications with outpatient MVA

$1268 savings

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Moving Abortion to an Outpatient Clinic- University of Michigan

Results: 60 women chose clinic, 29 women chose OR

MVA: 91% would choose again

• “get home soon,” “avoid GA”

• 69% less patient time

• 50% shorter procedure time

Dalton 2003

Cost savings of moving out of the OR of $3,000 per case

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Medications/Supplies Needed

• Analgesia• Anesthetic• Silver nitrate or ferric

subsulfate• Uterotonic agent• Rhogam

• Urine pregnancy tests• Emergency cart• Pharmacologic agents

for cervical ripening (optional)

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Equipment Needed

PROCEDURE• Aspirators• Cannulae• Speculae• Sharp-toothed and/or

atraumatic tenaculae• Antiseptic solution• Mechanical dilators• 20-cc syringe for local

anesthesia

TISSUE EXAMINATION• Basin for POC• Fine-mesh kitchen

strainer• Back light• Tools to grasp tissue

and POC• Specimen containers

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Finances Behind Out Patient Tx

• Diagnosis code: 637.9 (Spontaneous Abortion, without mention of complication)

• CPT Billing codes for in office management vs in patient management– 59812 – Treatment of incomplete abortion, any trimester,

completed surgically– 59820 – Treatment of missed abortion, completed

surgically, first trimester

• Reimbursement issues

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Conclusions

Evidence demonstrates

• Uterine evacuation can be managed safely in an out-patient clinic setting

• Moving out of the operating room – Saves both time, money, resources– Offers significant both choice & advantages to

both women & clinicians

ARHP“Never, ever, think outside the box.”

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CASES

Discussions about MVA

For Outpatient Management of Miscarriage

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Case 1 continued

The same 18 yro G2P1001, experiencing mild-moderate cramping with mild-moderate bleeding in your clinic, and an ultrasound evidence of an incomplete abortion elects an MVA procedure as she wants to take care of this as soon as possible.

You are performing the MVA-all seems to be going well. However, the aspirator is only about one-quarter full and you remember from this course that at this gestational age, you would expect more tissue than this. You are not sure whether or not you are done.

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Case 1 continued

How can you tell if you are done? List 4 signs suggesting completion.

What do you do?

For “bonus” credit---at what pregnancy age does the volume of POC become more than 60 cc (equivalent to the volume of the aspirator)?

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MVA Key Concepts

• MVA safe & effective for early pregnancy loss in first trimester

• Allows for care that day, in the office, with their primary provider

• Any uterine evacuation’s efficacy is improved by systematically checking for completion

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Case 2 continued

41 yo G2P1001 with an LMP suggesting a 10 week pregnancy but ultrasound findings revealing anembryonic pregnancy. The patient decided to opt for medical treatment.

She took both mifepristone and misoprostol and is now seeing you for her routine follow-up visit, scheduled 2 weeks after she took mifepristone. She has been having persistent spotting, and says that she is really “sick of it.” Vaginal ultrasound reveals a non-viable, persistent gestational sac. Specifically, there is no evidence of growth but the sac is still present.

ARHP

Case 2 continued

You counsel her about options, including observation, repeating misoprostol, and surgical completion. The woman has significant childcare problems and wants to minimize the number of visits she must make to your clinic. Therefore, she requests surgical completion.

ARHP

Case 2 continued

You perform MVA and are partway through the aspiration when you note that the cannula seems to be sliding back and forth over the uterine lining too easily; it feels like nothing is happening.

What could be going on?What do you do to test your answer to question #1?How might MVA on this patient be different from

that performed on surgical abortion patients who have not received mifepristone or misoprostol?

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MVA Key Concepts

• Helpful to trouble shoot & know how to solve common MVA problems

• Lack of suction can caused by– Device not assembled or working properly– Clogged cannula

• Can never go wrong by stopping & reassessing

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Case 3 continued

26 yo G2P2002 LMP uncertain because of irregular periods is at your office for pregnancy termination with either early intrauterine versus ectopic pregnancy in the differential. She would like to deal with it today and with you if possible. You want to make sure it is not an ectopic pregnancy….

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Case 3 continued

Initially, dilitation of the cervix seems slightly more difficult than usual. However, after the first two dilator passes, it then progresses uneventfully. A 6 mm cannula is placed in the os, the aspirator is connected, and only scant blood is obtained. Dilitation for correct placement is attempted again. Again, only scant blood is obtained.

What do you think is happening?What do you do now?

ARHP

MVA Key Concepts

• Checking device & placement helpful when not getting scant or no products back

• Ultrasound helps assess placement of cannula

• MVA can be help diagnose ectopic pregnancy

• Floating products of conception very helpful in assessing uterine contents (and is easy to do)