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Association of Reproductive Health Professionals www.arhp.org Options for Therapeutic Abortion: Manual Vacuum Aspiration and Medication Management

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Options for Therapeutic Abortion: Manual Vacuum Aspiration and Medication Management. Association of Reproductive Health Professionals www.arhp.org. Expert Medical Advisory Committee. Herbert P. Brown, MD Michelle Forcier, MD, MPH Emily Godfrey, MD, MPH Marji Gold, MD - PowerPoint PPT Presentation

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Page 1: Association of Reproductive Health Professionals

Association of Reproductive Health Professionalswww.arhp.org

Options for Therapeutic Abortion: Manual Vacuum Aspiration and Medication Management

Page 2: Association of Reproductive Health Professionals

Expert Medical Advisory Committee• Herbert P. Brown, MD• Michelle Forcier, MD, MPH• Emily Godfrey, MD, MPH• Marji Gold, MD • Jini Tanenhaus, PA, MA

Page 3: Association of Reproductive Health Professionals

Learning Objectives• List four clinical indications for manual vacuum

aspiration (MVA)• List four factors to consider when counseling

women about MVA versus medical management of early pregnancy loss

more…

Page 4: Association of Reproductive Health Professionals

Learning Objectives (continued)

• List three conditions in a patient that should cause a provider to use caution before providing MVA  or medical management of early pregnancy loss

• List at least one medication regimen used for early medication abortion

Page 5: Association of Reproductive Health Professionals

Module 1:MVA Overview

Page 6: Association of Reproductive Health Professionals

Unintended Pregnancy in the United States (2001)

Finer LB, Henshaw SK. Perspect Sex Reprod Health. 2006.

Intended

6.3 million pregnancies

Birth

Abortion

Fetal Loss

Unintended

Page 7: Association of Reproductive Health Professionals

Outcomes of Unintended PregnanciesApproximately 3 million annually in the United States

Finer LB, Henshaw SK. Perspect Sex Reprod Health. 2006.

44% BirthAbortion 42%

Miscarriage/Fetal Demise

14%

Page 8: Association of Reproductive Health Professionals

Abortions by Length of Pregnancy

Strauss LT, et al. MMWR. 2006

≤89 to 1011 to 1213 to 1516 to 20≥21

Weeks Gestation

61%18%

10%

6%

1%

4%

Page 9: Association of Reproductive Health Professionals

What Is a Manual Vacuum Aspirator?

Creinin MD, et al. Obstet Gynecol Surv. 2001.; Goldberg AB, et al. Obstet Gynecol. 2004.’ Hemlin J, et al. Acta Obstet Gynecol Scand. 2001.

Manual vacuum aspirator• Has locking valve• Is portable and reusable• Vacuum is equivalent to

electric pump• Efficacy is same as electric

vacuum (98%–99%)• Has semi-flexible plastic cannula

Page 10: Association of Reproductive Health Professionals

What Is an Electric Vacuum Aspirator?

Creinin MD, et al. Obstet Gynecol Surv. 2001.; Goldberg AB, et al. Obstet Gynecol. 2004.; Hemlin J, et al. Acta Obstet Gynecol Scand. 2001.

Electric vacuum aspirator• Uses an electric pump or

suction machine connected via flexible tubing

• Has a plastic or metal cannula

• Typically used in centralized settings with high caseloads

Page 11: Association of Reproductive Health Professionals

History of MVA

Bird ST, et al. Contraception. 2003.; Edwards J, et al. Curr Probl Obstet Gynecol Fertil. 1997.; Karman H, et al. Lancet. 1972.

1973: Helms Amendment enacted

1973: USAID sponsors Ipas

1980s: MVA marketed worldwide

1990s: MVA used in >100 countries

Page 12: Association of Reproductive Health Professionals

Comparison of EVA to MVA

Dean G, et al. Contraception. 2003.

EVA MVAVacuum Electric pump Manual aspiratorNoise Variable Quiet

Portable Not easily YesCannula 4–16 mm 4–12 mmCapacity 350–1,200 cc 60 cc

Suction Constant Decreases to 80% (50 mL) as aspirator fills

Page 13: Association of Reproductive Health Professionals

Products of Conception (POC)

Edwards J, et al. Am J Obstet Gynecol. 1997.MacIsaac L, et al. Am J Obstet Gynecol. 2000.

Procedure is complete when POC are identified

Electric Suction Machine

MVA Aspirator

Page 14: Association of Reproductive Health Professionals

Clinical Indications for MVA • Uterine evacuation in the first trimester:

▪ Induced abortion▪ Spontaneous abortion

• Incomplete medication abortion• Uterine sampling• Post-abortal hematometra

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.

Page 15: Association of Reproductive Health Professionals

Complications with MVA• Very rare • Same as EVA• May include:

▪ Incomplete evacuation▪ Uterine or cervical injury▪ Infection▪ Hemorrhage▪ Vagal reaction

MVA Label. Ipas. 2004.

Page 16: Association of Reproductive Health Professionals

Putting Abortion into Perspective…

Gold RB, Richards C. Issues Sci Technol. 1990.; Hatcher RA. Contracept Technol Update. 1998.; Mokdad AH, et al. MMWR Recomm Rep. 2003.

Incident Chance of death

Terminating pregnancy < 9 weeks 1 in 500,000

Terminating pregnancy > 20 weeks 1 in 8,000

Giving birth 1 in 7,600

Driving an automobile 1 in 5,900

Using a tampon 1 in 350,000

Page 17: Association of Reproductive Health Professionals

Post-Abortion Care

Creinin MD, et al. Obstet Gynecol Surv. 2001.; Goldberg AB, et al. Obstet Gynecol. 2004.; Hemlin J, Moller B. Acta Obstet Gynecol Scand. 2001.

• Women desiring pregnancy▪ Vitamin and diet recommendations▪ Toxic-exposure avoidance guidelines

• Women avoiding pregnancy▪ Contraceptive counseling▪ Contraception initiated on day of MVA

Page 18: Association of Reproductive Health Professionals

MVA vs. EVA Complication RatesMethods• 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.

more…

Page 19: Association of Reproductive Health Professionals

MVA vs. EVA Complication Rates (continued)

Goldberg AB, et al. Obstet Gynecol. 2004.

Complications

• 2.5% for MVA• 2.1% for EVA (p = 0.56)• No significant difference

more…*Elective not spontaneous studies

Page 20: Association of Reproductive Health Professionals

MVA vs. EVA Complication Rates (continued)

Goldberg AB, et al. Obstet Gynecol. 2004.

Choice of MVA vs EVA in procedures

• Attendings: 52% MVA

• Gyn residents: 59% MVA

• Other residents: 76% MVA (p<0.001)

*Elective not spontaneous studies

Page 21: Association of Reproductive Health Professionals

Conventional Wisdom and Abortion Care

Depineres T, Stewart F. NAF. 2002. ; Castadot RG. Fertil Steril. 1986.Edwards J, Creinin MD. Curr Probl Obstet Gynecol Fertil. 1997.

1970s

•Wait 7+ weeks for lowest risk of complications

Today

• Ultra-sensitive pregnancy tests

• POC inspection• Ultrasound• Medication abortion• MVA• No reason to wait

Page 22: Association of Reproductive Health Professionals

What Services Do You Provide?

Use index cards provided to answer the following. Do not write your name.• Does your facility currently provide vacuum

aspiration abortions before 6 weeks? ▪ Yes/No

• Are there clinical or program-related barriers to providing early abortion with vacuum aspiration? ▪ Yes/No (If yes, list the most significant barriers.)

Page 23: Association of Reproductive Health Professionals

Earlier Procedures Are Safer

Bartlet L, et al. Obstet Gynecol. 2004.

Gestational Age

Strongest risk factor for abortion-related

mortality

Abortions at <8 weeks = lowest risk of death

Page 24: Association of Reproductive Health Professionals

“…Because access to abortions even one week earlier reduces the risk of death…increased access to early abortion services may increase the proportion of abortions performed at the lower-risk, early gestational ages and help reduce maternal deaths.”

Offering Services as Early as Possible

Bartlet L, et al. Obstet Gynecol. 2004.

Page 25: Association of Reproductive Health Professionals

Early Abortion with Vacuum Aspiration

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%

Baird TL, Flinn SK. 2001.; Edwards J, Carson SA. Am J Obstet Gynecol. 1997.Edwards J, Creinin MD. Curr Probl Obstet Gynecol Fertil. 1997. Hemlin J, Moller B. Acta Obstet Gynecol Scand. 2001.; Paul ME, et al. Am J Obstet Gynecol. 2002.

Page 26: Association of Reproductive Health Professionals

Early Abortion with MVA: Study • Methods

▪ 2,399 MVA procedures, < 6 weeks LMP▪ Meticulous inspection of POC immediately after

MVA• Results

▪ 99.2% effective in terminating pregnancy▪ 6 repeat aspirations (0.25%)▪ 14 ectopic pregnancies (0.6%) diagnosed and

treated

Edwards J, Creinin MD. Curr Probl OIbstet Gynecol Fertil. 1997.

Page 27: Association of Reproductive Health Professionals

Early Abortion with MVA or EVA: Study

Methods• 1,132 women, ≤ 6 weeks LMP• Of 1,093 procedures:

▪ 52% MVA▪ 40% EVA▪ 8% both

• Examination of POC immediately after procedure

Paul ME, et al. Am J Obstet Gynecol. 2002.

more…

Page 28: Association of Reproductive Health Professionals

Early Abortion with MVA or EVA: Study (continued)

Paul ME, et al. Am J Obstet Gynecol. 2002.

more…

17 of 1,132Required re-aspiration

Results

2.3% of study population

Page 29: Association of Reproductive Health Professionals

Early Abortion with MVA or EVA: Study (continued)

Paul ME, et al. Am J Obstet Gynecol. 2002.

more…

Failure rates by technique among women with follow-up (95% CI):

1.1% 2.9% 7.5%(0.4%-3.0%) (1.4%-5.7%) (2.1%-18.2%)

MVA EVA Both used

Page 30: Association of Reproductive Health Professionals

Early Abortion with MVA or EVA: Study (continued)

Of the 750 women with follow-up, 13 experienced other complications:• 4 incomplete abortions• 2 unrecognized ectopic pregnancies • 1 hematometra• 4 pelvic infections• 3 re-aspirations for pain and bleeding despite

negative pathology

Paul ME, et al. Am J Obstet Gynecol. 2002.

Page 31: Association of Reproductive Health Professionals

MVA and POC: Study

• In group overall ▪ n = 1,726, up to 10 weeks LMP

• Complication rates between MVA and EVA▪ 37 patients at < 6 weeks’ gestation▪ In 35 of 37, provider chose MVA ▪ No re-aspirations needed in patients < 6 weeks

Goldberg AB, et al. Obstet Gynecol. 2004.

more…

Page 32: Association of Reproductive Health Professionals

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.

Page 33: Association of Reproductive Health Professionals

Safety and Efficacy: Family Practice Office

Methods• Abortion using MVA, <12 weeks LMP• Retrospective chart review, N = 1,677 • 60% performed by residents under supervision• 40% performed by attendings

Westfall JM, et al. Arch Fam Med. 1998.

more…

Page 34: Association of Reproductive Health Professionals

Safety and Efficacy: Family Practice Office (continued)

Results• 99.5% effective• 1.3% minor complications• No hospitalizations

Westfall JM, et al. Arch Fam Med. 1998.

Page 35: Association of Reproductive Health Professionals

Patient Satisfaction

• Both EVA and MVA groups were highly satisfied

• No differences in:▪ Pain▪ Anxiety▪ Bleeding▪ Acceptability ▪ Satisfaction

• More EVA patients were bothered by noiseBird ST, et al. Contraception. 2003.; Dean G, et al. Contraception. 2003.; Edelman A, et al. Am J Obstet Gynecol. 2001.

Page 36: Association of Reproductive Health Professionals

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▪ Identifying products of conception▪ Instrument processing for multiple use

Page 37: Association of Reproductive Health Professionals

MVA in Office Settings• Safety and efficacy equivalent to EVA• Portable• Simple• Low cost• Small and quiet

Goldberg AB, et al. Obstet Gynecol. 2004.

Beneficial to incorporate MVA servicesinto the office setting.

Page 38: Association of Reproductive Health Professionals

Module 2:MVA Procedure

Page 39: Association of Reproductive Health Professionals

MVA Steps

Gather required supplies

Charge aspirator

Stabilize and anesthetize cervix

Insert cannula

Empty uterus

After counseling and support …

Page 40: Association of Reproductive Health Professionals

MVA Instruments

Page 41: Association of Reproductive Health Professionals

Steps for Performing MVA

A step-by-step, one- page poster is

available from the manufacturer to guide clinicians

through the procedure

Page 42: Association of Reproductive Health Professionals

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.

Page 43: Association of Reproductive Health Professionals

Effective Pain Management• Respectful, informed, and supportive staff• Warm, friendly environment• Gentle operative technique• Women’s involvement• Effective pain medications

Page 44: Association of Reproductive Health Professionals

Pain Management Philosophies • Minimize risk/maximize benefit• Take away all pain/all feeling• Get through it

Page 45: Association of Reproductive Health Professionals

Pain Management Techniques

Lichtengerg ES, et al. Contraception. 2001.Good M, et al. Pain Manag Nurs. 2002.

Local

General or nitrous

Local + IV

10%

32% 58%

With addition of:• Focused breathing: 76%• Visualization: 31%• Localized massage: 14%

Page 46: Association of Reproductive Health Professionals

Paracervical Block

Regular InjectionDeep Injection

Castleman L, Mann C. 2002. Maltzer DS, et al. 1999.

Page 47: Association of Reproductive Health Professionals

Efficacy of Ancillary Anesthesia

• Importance of psychological preparation and support

• 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.

Page 48: Association of Reproductive Health Professionals

Sharp Curettage and Pain

• Often requires increased dilatation

• Often painful• More difficult to

reduce anesthesia

Forna F, Gulmezoglu AM. Cochrane Library. 2002.

Page 49: Association of Reproductive Health Professionals

Sharp Curettage and MVA• Generally not indicated • Not routinely recommended after MVA

WHO. 2003

more…

Page 50: Association of Reproductive Health Professionals

Sharp Curettage and MVA (continued)

“…Health managers and policy makers should make all possible efforts to replace sharp curettage (D&C) with vacuum aspiration.”

WHO, 2003

WHO, Safe Abortion: Technical and Policy Guidance for Health Systems. 2003.

Page 51: Association of Reproductive Health Professionals

Pain Management Tips

Affirm patient’s viewpoint

Provide medical information

Avoid glib reassurances

Tell patient her fears are common

Help patient differentiate pain

Page 52: Association of Reproductive Health Professionals

Pain Management Options: Summary• More to pain management than avoiding pain• No pain panacea• Women should be involved• Curette check increases pain; usually not needed• Pre-procedure preparation and psychological

support can reduce anxiety and improve overall experience

Page 53: Association of Reproductive Health Professionals

Who Can Provide MVA in the United States?

• All physicians • All mid-level providers including:

▪ Physician assistants▪ Nurse practitioners ▪ Nurse midwives

• Research your state’s individual laws, rulings, and professional scopes of practice

more…

Page 54: Association of Reproductive Health Professionals

Who Can Provide MVA in the United States? (continued)

Legal use may depend upon specific diagnosis of patient:

• Incomplete abortion• Prolonged uterine bleeding• Endometrial biopsy• Elective abortion where legal

Page 55: Association of Reproductive Health Professionals

MVA Training Organizations• Association of Reproductive Health Professionals

(ARHP)• Clinician Training Initiative (CTI)—Planned

Parenthood of New York City (PPNYC)• National Abortion Federation (NAF)• Planned Parenthood® Federation of America (PPFA)• Ipas• Physicians for Reproductive Choice and Health

(PRCH)

Page 56: Association of Reproductive Health Professionals

Facilities Needed for MVA

• Privacy for counseling • Procedure room

▪ Exam table▪ Space for supplies,

processing instruments, and examining products of conception

Page 57: Association of Reproductive Health Professionals

Medications and Supplies Needed for MVA

• Analgesia• Anesthetic• Silver nitrate or ferric subsulfate• Uterotonic agent• Rhogam

more…

Page 58: Association of Reproductive Health Professionals

Medications and Supplies Needed for MVA (continued)

• Urine pregnancy tests• Emergency cart• Pharmacologic agents for cervical ripening

(optional)

Page 59: Association of Reproductive Health Professionals

Equipment Needed for MVA

Procedure• Aspirators• Cannulae• Speculae• Sharp-toothed and/or atraumatic tenaculae

more…

Page 60: Association of Reproductive Health Professionals

Equipment Needed for MVA (continued)

Procedure• Antiseptic solution• Mechanical dilators• 20-cc syringe for local anesthesia

more…

Page 61: Association of Reproductive Health Professionals

Equipment Needed for MVA (continued)

Page 62: Association of Reproductive Health Professionals

Equipment for POC Exam after MVA

Tissue examination• Basin for POC• Fine-mesh kitchen strainer• Back light or enhanced light• Tools to grasp tissue and POC• Specimen containers

Hyman AG, Castleman L. Ipas. 2005

Page 63: Association of Reproductive Health Professionals

Ultrasound and MVA

• Not required for MVA

• Used by some providers routinely

• Use contingent on provider preference and experience

Word Health Organization. 2003.

Page 64: Association of Reproductive Health Professionals

Women’s Access to Care

Leonard A, Winkler J. Adv Abortion Care. 1991.

Page 65: Association of Reproductive Health Professionals

Incorporating MVA Into Practice

What does it take to incorporate the MVA

procedure into a clinical practice?

Page 66: Association of Reproductive Health Professionals

MVA Staffing and Facilities Requirements: Summary• All physicians and advanced practice clinicians in

many states can provide MVA• Facilities requirements include medication,

supplies, equipment, and instruments• Use of ultrasound is not required

Page 67: Association of Reproductive Health Professionals

MVA Patient Intake and Counseling

Page 68: Association of Reproductive Health Professionals

Contraindications to MVA • First-trimester induced abortion—NONE• First-trimester spontaneous abortion—NONE• Completion of incomplete abortion—NONE• Suspected pregnancy—endometrial biopsy should

NOT be performed

Ipas. 2007.

Page 69: Association of Reproductive Health Professionals

Use Caution in Women with…• Uterine anomalies• Coagulation problems• Active pelvic infection • Extreme anxiety• Any condition causing the patient to be medically

unstable

Ipas. 2007.

Page 70: Association of Reproductive Health Professionals

Patient Intake Steps for MVA• Medical history• Lab work, including -hCG• Determine gestational age• Educate about procedure and

pain management• Informed consent • Discuss contraception

MacIsaac L, Darney P. Am J Obstet Gynecol. 2000. World Health Organization. 2003.

Page 71: Association of Reproductive Health Professionals

Counseling for MVA

Effective counseling occurs before, during, and after the procedure• Woman-centered • Structured completely

around the women’s needs and concerns

more…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. 2005

Page 72: Association of Reproductive Health Professionals

Counseling for MVA (continued)

• Prepare women for procedure-related effects

• Address women’s concerns about future desired pregnancies

more…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. 2005

Page 73: Association of Reproductive Health Professionals

Counseling for MVA (continued)

Picker Institute. 1999.

Quality of counseling

Patient satisfaction with care

Page 74: Association of Reproductive Health Professionals

Post-Procedure Care

• Observe for complications▪ Bleeding ▪ Pain

• Monitor pain and treat accordingly• Monitor vital signs• Check bleeding and pain

more…

Page 75: Association of Reproductive Health Professionals

Post-Procedure Care (continued)

• Give instructions for aftercare/follow-up• Discuss contraception, if appropriate• Discharge patient

▪ Tolerates oral intake (general anesthesia only)▪ Vital signs are normal▪ Bleeding is minimal

Lichtenberg ES, Shott S. Obstet Gynecol. 2003.

Page 76: Association of Reproductive Health Professionals

Instructions for Aftercare• Warning signs to call a clinician• Pain management options• Prophylactic antibiotics

▪ Many regimens effective• When to return to normal

activities

Lichtenberg ES, Shott S. Obstet Gynecol. 2003.

Page 77: Association of Reproductive Health Professionals

When Women Should Contact Clinician• Heavy bleeding with dizziness, lightheadedness• Worsening pain not relieved with medication• Flu-like symptoms lasting >24 hours• Fever or chills• Syncope• Any questions

Page 78: Association of Reproductive Health Professionals

Contraception After MVAOvulation may occur within 7–10 days post-MVA• Dispense EC with instructions for use• Can start hormonal contraceptives immediately• Can insert IUD immediately post-procedure

more…

Page 79: Association of Reproductive Health Professionals

Contraception After MVA (continued)

• Tubal ligation can be performed post-procedure or scheduled; develop interim contraception plan

• Use barrier contraceptive with first and subsequent intercourse

Page 80: Association of Reproductive Health Professionals

Module 3:Medication Abortion

Page 81: Association of Reproductive Health Professionals

Medication Abortion

Jones RK, Henshaw SK. Perspet Sex Reprod Health. 2002.

Page 82: Association of Reproductive Health Professionals

Medication Abortion Regimens

• FDA-approved regimen▪ Mifepristone 600 mg PO followed by misoprostol

400 µg orally 48 hours later• Evidence-based regimens

▪ Mifepristone 200 mg followed by 600 µg of oral misoprostol

▪ Mifepristone 200 mg followed by 800 µg of vaginal misoprostol

WHO Task Force. BJOG. 2000; Peyron R, et al. N Engl J Med. 1993.; Spitz IM, et al. N Eng J Med. 1998.; Aubény E, et al. Int J Fertil Menopausal Stud. 1995; Kahn JG, et al. Contraception. 2000.

Page 83: Association of Reproductive Health Professionals

Protocols – Medication AbortionFDA Approved Regimen(Based on evidence up to 1996)

Alternative Evidence-Based Regimen(Based on current evidence)

Gestational age:Up to 49 days after first day of last period

Gestational age:Up to 56 days after first day of last period

Gestational age:Up to 63 days after first day of last period

Mifepristone 600 mg. (swallowed in the office)

Mifepristone 200 mg.(swallowed in the office)

Mifepristone 200 mg.(swallowed in the office)

Misoprostol 400 mcg. Oral useSwallowed in the office48 hours after taking mifepristone

Misoprostol 800 mcg. Buccal useUsed at home 24-48 hours after taking mifepristonePut in the cheek to melt

Misoprostol 800 mcg. Vaginal useUsed at home 6–72 hours after taking mifepristonePut in the vagina

Office follow-up 10–15 days after taking mifepristone

Office follow-up 4–14 days after taking mifepristone

Office follow-up 4–14 days after taking mifepristone

3 office visits 2 office visits 2 office visits

RHEDI. Montifiore Medical Center. www.rhedi.org

Page 84: Association of Reproductive Health Professionals

Evidence-Based Regimens• 200-mg dose of mifepristone• Buccal or vaginal administration of misoprostol• Home use of misoprostol• Flexibility in day of vaginal misoprostol use• Flexibility in initial follow-up evaluation

Kahn JG. Contraception. 2000.; Middleton T. Contraception. 2005.; El-Rafaey H. N Engl J Med. 1995.; Schaff EA. J Fam Pract. 1997.; Schaff EA. Contraception. 1999.; Schaff EA. JAMA. 2000.; Schaff EA. Contraception. 2001.; Schaff EA. Contraception. 2000.

Page 85: Association of Reproductive Health Professionals

Medication Abortion Efficacy

Gestational age (weeks)

Complete abortion rate (%)

Time to expulsion (after misoprostol)

< 49 91–97 49%–61% within 4 hours

< 56 83–95 87%–88% within 24 hours

< 63 88

600 mg oral mifepristone/400 mcg oral misoprostol

WHO Task Force. BJOG. 2000.; Peyron R, et al. N Engl J Med. 1993. Spitz IM, et al. N Engl J Med. 1998; Winikoff B, et al. Am J Obstet Gynecol. 1997.

Page 86: Association of Reproductive Health Professionals

Medication Abortion Efficacy

Gestational age (weeks)

Complete abortion rate (%)

Time to expulsion (after misoprostol)

< 49 96–97 56% within 4 hours

50–63 89–93

200 mg oral mifepristone/600 mcg oral misoprostol

McKinley C, et al. Hum Reprod. 1993.Baird DT, et al. Hum Reprod. 1995.

Page 87: Association of Reproductive Health Professionals

Plasma Concentration of Misoprostol

Wiehe E, et al. Obstet Gynecol. 2002.; el-Refaey H, et al. N Engl J Med. 1995.Schaff EA, et al. Contraception. 2001; Zieman M, et al. Obstet Gynecol. 1997; Fjerstad, 2006.

Pla

sma

mis

opro

stol

con

cent

ratio

n (p

g/m

L)

oral (n = 10)

vaginal (n = 10)

050

100150200250300350

60 min 120 min 180 min 240 min

Page 88: Association of Reproductive Health Professionals

Medication Abortion Efficacy

Gestational age (weeks)

Complete abortion rate (%)

Time to expulsion (after misoprostol)

<56 98 93% within 4 hours

<63 95

600 mg oral mifepristone/800 mcg vaginal misoprostol

Schaff EA, et al. Contraception. 1999.el-Refaey H, et al. N Engl J Med. 1995.

Page 89: Association of Reproductive Health Professionals

Medication Abortion Efficacy

Gestational age (weeks)

Complete abortion rate (%)

Time to expulsion (after misoprostol)

< 49 98 94% within 6 hours

< 56 97–98

< 63 98

200 mg oral mifepristone/800 mcg vaginal misoprostol

Ashok PW, et al. Hum Reprod. 1998.Schaff EA, et al. Contraception. 1999.

Page 90: Association of Reproductive Health Professionals

Medication Abortion Safety Issues• Atypical presentation of infection and sepsis• Prolonged heavy vaginal bleeding

Danco Laboratories. 2005.; FDA. 2006.Green MF. N Engl J Med. 2005.

Page 91: Association of Reproductive Health Professionals

Do Not Use in Women with…• Confirmed or suspected ectopic pregnancy• IUD in place• Long-term corticosteroid use• Hemorrhagic disorders or inherited porphyrias

Danco Laboratories. 2005.

more…

Page 92: Association of Reproductive Health Professionals

Do Not Use in Women with…(continued)

• Concurrent anticoagulant use• Chronic adrenal failure• Allergy to mifepristone, misoprostol, or other

prostaglandin

Danco Laboratories. 2005.

Page 93: Association of Reproductive Health Professionals

Patient Intake Exercise

Page 94: Association of Reproductive Health Professionals

Patient Intake Steps for Medication Abortion• Medical history• Lab work• Determine gestational age• Educate about procedure and pain management• Informed consent and patient agreement• Medication guide • Discuss contraception

Danco Laboratories. 2005. World Health Organization. 2003.

Page 95: Association of Reproductive Health Professionals

Pain Management• Ibuprofen or acetaminophen initially• Oral narcotics if necessary

Grimes DA, Creinin MD. Ann Intern Med. 2004.

Page 96: Association of Reproductive Health Professionals

When Women Should Contact Clinician• Heavy bleeding with dizziness, lightheadedness• Worsening pain not relieved with medication• Flu-like symptoms lasting >24 hours• Fever or chills• Syncope• Any questions

FDA. 2006.

Page 97: Association of Reproductive Health Professionals

Clostridium sordelli Infection

• Fever may not develop• Consider other signs of infection:

▪ Weakness▪ Nausea▪ Vomiting▪ Diarrhea

FDA. 2006.

Page 98: Association of Reproductive Health Professionals

Follow-up After Medication Abortion

• Assess completion of abortion by▪ Patient history▪ Serial HCGs or sonography▪ Speculum and/or bimanual exam as indicated

• Documentation of missed follow-up• If procedure is incomplete or unsuccessful,

MVA can be used for retained POC

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Contraception After Medication Abortion• Ovulation may occur within 7–10 days after abortion• Dispense EC with instructions for use• Can start hormonal contraceptives before follow-up• Can insert IUD when abortion is confirmed

Stewart FH, et al. 2004.

Page 100: Association of Reproductive Health Professionals

Becoming a Medication Abortion Provider

• Apply to distributor to obtain mifepristone: www.earlyoptionpill.com

• Training available through National Abortion Federation: www.prochoice.org

Grimes DA, Creinin MD. Ann Intern Med. 2004.

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Module 4: Counseling Women on MVA Versus Medication Abortion

Page 102: Association of Reproductive Health Professionals

Factors to Consider• Duration of pregnancy• Efficacy• Safety• Side effects• Use of anesthesia• Location• Time required

Page 103: Association of Reproductive Health Professionals

Options for Terminating Pregnancy

0 12 24 Weeks LMP

Dilation and Evacuation

Electric Vacuum Aspiration

Manual Vacuum Aspiration

Methotrexate/Misoprostol

Mifepristone/Misoprostol

Amniocentesis/AmnioinfusionUterotonic/Hypertonic

Stewart FH, et al. 2004.

Page 104: Association of Reproductive Health Professionals

Efficacy of Abortion Options

Surgical and medication abortion are highly effective

0 1 2 3 4 5 6 7 8 9 10 Weeks LMP

Manual vacuum aspiration 99%

Medication abortion (oral)91%–97% 88%

98%Medication abortion

(vaginal)Edwards J, Creinin MD. Curr Probl Obstet Gynecol Fertil. 1997.Goldberg AB, et al. Obstet Guynecol. 2004; WHO Task Force. BJOG. 2000.Ashok PW, et al. Hum Reprod. 1998.

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Safety of Abortion

MVA

• Uterine or cervical injury

• Infection

Surgical and medication abortion are low risk

Medication

• Infection• Heavy bleeding

Stewart FH, et al. 2004.; Danco Laboratories. 2005.FDA. 2006.; Green MF. N Engl J Med. 2005.

Page 106: Association of Reproductive Health Professionals

Expectations

MVA

• Cramping• Bleeding

Usually subside quickly

Medication

• Cramping• Bleeding• Nausea/vomiting• Diarrhea• Fever/chills• Fatigue

Grimes DA, Creinin MD. Ann Intern Med. 2004.NAF. 2006.

Page 107: Association of Reproductive Health Professionals

Location: Where Abortion Occurs

MVA

• Hospital or office setting

Medication

• Begins in hospital/office

• Occurs at home

NAF. 2006.

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Time Required for Abortion

MVA

• Complete within minutes

• 1 visit to provider

Medication• Complete within

24–48 hours• 2 visits to provider

(evidence-based)

NAF. 2006.

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Advantages of Abortion Options

Stewart FH, et al. 2004.NAF. 2006.

MVA• Quicker• Woman less

involved • More certain

Medication• More natural• More private• Usually avoids

surgery

Page 110: Association of Reproductive Health Professionals

Disadvantages of Abortion Options

Stewart FH, et al. 2004.NAF. 2006.

MVA• Invasive• Less private• Small risk of

injury or infection

Medication• Waiting, uncertainty• Longer bleeding,

cramping, nausea• Additional clinic visit

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Appendix

Page 112: Association of Reproductive Health Professionals

Expert Medical Advisory CommitteeHerbert P. Brown, MD Clinical Associate Professor of Ob/GynUniversity of Texas Health Science CenterSan Antonio, TX

more…

Michelle Forcier, MD, MPH Adjunct Assistant Clinical Professor of Pediatrics University of North Carolina School of Pediatrics and Family Medicine and Duke University School of Pediatrics Chapel Hill, NC

Emily Godfrey, MD, MPH Assistant Professor, Department of Family Medicine University of Illinois at Chicago Chicago, IL

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Expert Medical Advisory Committee (continued)

Marji Gold, MD Professor of Family and Social MedicineAlbert Einstein College of MedicineBronx, NY

Jini Tanenhaus, PA, MA Associate Vice President, Clinician Training InitiativePlanned Parenthood of New York CityNew York, NY