Title in Initial Caps: 40point Arial

1
Options for Therapeutic Abortion Manual Vacuum
Aspiration and Medication Management
Association of Reproductive Health
Professionals www.arhp.org
2
Expert Medical Advisory Committee

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

Required Slide
3
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
4
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

5
Module 1MVA Overview
6
Unintended Pregnancy in the United States (2001)
6.3 million pregnancies
51
51
22
49
20
14
7
Finer LB, Henshaw SK. Perspect Sex Reprod Health.
2006.
7
Outcomes of Unintended Pregnancies
Approximately 3 million annually in the United
States
Finer LB, Henshaw SK. Perspect Sex Reprod Health.
2006.
8
Abortions by Length of Pregnancy
Strauss LT, et al. MMWR. 2006
9
What Is a Manual Vacuum Aspirator?

• Manual vacuum aspirator
• Has locking valve
• Is portable and reusable
• Vacuum is equivalent to electric pump
• Efficacy is same as electric vacuum (9899)
• Has 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.
10
What Is an Electric Vacuum Aspirator?

• 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

Creinin MD, et al. Obstet Gynecol Surv. 2001.
Goldberg AB, et al. Obstet Gynecol. 2004. Hemlin
J, et al. Acta Obstet Gynecol Scand. 2001.
11
History of MVA
1973 Helms Amendment enacted
1980s MVA marketed worldwide
1973 USAID sponsors Ipas
1990s MVA used in gt100 countries
Bird ST, et al. Contraception. 2003. Edwards J,
et al. Curr Probl Obstet Gynecol Fertil. 1997.
Karman H, et al. Lancet. 1972.
12
Comparison of EVA to MVA
Dean G, et al. Contraception. 2003.
13
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.
2000.
14
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.
15
Complications with MVA

• Very rare
• Same as EVA
• May include
• Incomplete evacuation
• Uterine or cervical injury
• Infection
• Hemorrhage
• Vagal reaction

MVA Label. Ipas. 2004.
16
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.
17
Post-Abortion Care

• Women desiring pregnancy
• Vitamin and diet recommendations
• Toxic-exposure avoidance guidelines
• Women avoiding pregnancy
• Contraceptive counseling
• Contraception initiated on day of MVA

Creinin MD, et al. Obstet Gynecol Surv. 2001.
Goldberg AB, et al. Obstet Gynecol. 2004. Hemlin
J, Moller B. Acta Obstet Gynecol Scand. 2001.
18
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

more
Goldberg AB, et al. Obstet Gynecol. 2004.
19
MVA vs. EVA Complication Rates (continued)
more
Elective not spontaneous studies
Goldberg AB, et al. Obstet Gynecol. 2004.
20
MVA vs. EVA Complication Rates (continued)
Elective not spontaneous studies
Goldberg AB, et al. Obstet Gynecol. 2004.
21
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.
22
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.)

23
Earlier Procedures Are Safer
Abortions at lt8 weeks lowest risk of death
Bartlet L, et al. Obstet Gynecol. 2004.
24
Offering Services as Early as Possible
Because access to abortions even one week
earlier reduces the risk of deathincreased
access to early abortion services may increase
the proportion of abortions performed at the
lower-risk, early gestational ages and help
reduce maternal deaths.


Bartlet L, et al. Obstet Gynecol. 2004.
25
Early Abortion with Vacuum Aspiration
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.
26
Early Abortion with MVA Study

• Methods
• 2,399 MVA procedures, lt 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.
27
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

more
Paul ME, et al. Am J Obstet Gynecol. 2002.
28
Early Abortion with MVA or EVA Study (continued)
Results
17 of 1,132
Required re-aspiration
2.3 of study population
more
Paul ME, et al. Am J Obstet Gynecol. 2002.
29
Early Abortion with MVA or EVA Study (continued)
Failure rates by technique among women with
follow-up (95 CI)
1.1
2.9
7.5
(1.4-5.7)
(0.4-3.0)
(2.1-18.2)
Both used
MVA
EVA
more
Paul ME, et al. Am J Obstet Gynecol. 2002.
30
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.
31
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

more
Goldberg AB, et al. Obstet Gynecol. 2004.
32
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.
33
Safety and Efficacy Family Practice Office

• Methods
• Abortion using MVA, lt12 weeks LMP
• Retrospective chart review, N 1,677
• 60 performed by residents under supervision
• 40 performed by attendings

more
Westfall JM, et al. Arch Fam Med. 1998.
34
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.
35
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.
36
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

37
MVA in Office Settings

• Safety and efficacy equivalent to EVA
• Portable
• Simple
• Low cost
• Small and quiet

Beneficial to incorporate MVA servicesinto the
office setting.
Goldberg AB, et al. Obstet Gynecol. 2004.
38
Module 2MVA Procedure
39
MVA Steps
After counseling and support
40
MVA Instruments
41
Steps for Performing MVA
A step-by-step, one- page poster is available
from the manufacturer to guide clinicians through
the procedure
42
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.
43
Effective Pain Management

• Respectful, informed, and supportive staff
• Warm, friendly environment
• Gentle operative technique
• Womens involvement
• Effective pain medications

44
Pain Management Philosophies

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

45
Pain Management Techniques

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

General or nitrous
Local IV
Local
Lichtengerg ES, et al. Contraception. 2001. Good
M, et al. Pain Manag Nurs. 2002.
46
Paracervical Block
Deep Injection
Regular Injection
Castleman L, Mann C. 2002. Maltzer DS, et al.
1999.
47
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.
48
Sharp Curettage and Pain

• Often requires increased dilatation
• Often painful
• More difficult to reduce anesthesia

Forna F, Gulmezoglu AM. Cochrane Library. 2002.
49
Sharp Curettage and MVA

• Generally not indicated
• Not routinely recommended after MVA

more
WHO. 2003
50
Sharp Curettage and MVA (continued)


Health managers and policy makers should make
all possible efforts to replace sharp curettage
(DC) with vacuum aspiration.
WHO, 2003
WHO, Safe Abortion Technical and Policy Guidance
for Health Systems. 2003.
51
Pain Management Tips
52
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

53
Who Can Provide MVA in the United States?

• All physicians
• All mid-level providers including
• Physician assistants
• Nurse practitioners
• Nurse midwives
• Research your states individual laws, rulings,
  and professional scopes of practice

more
54
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

55
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)

56
Facilities Needed for MVA

• Privacy for counseling
• Procedure room
• Exam table
• Space for supplies, processing instruments, and
  examining products of conception

57
Medications and Supplies Needed for MVA

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

more
58
Medications and Supplies Needed for MVA
(continued)

• Urine pregnancy tests
• Emergency cart
• Pharmacologic agents for cervical ripening
  (optional)

59
Equipment Needed for MVA

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

more
60
Equipment Needed for MVA (continued)

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

more
61
Equipment Needed for MVA (continued)
62
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
63
Ultrasound and MVA

• Not required for MVA
• Used by some providers routinely
• Use contingent on provider preference and
  experience

Word Health Organization. 2003.
64
Womens Access to Care
Leonard A, Winkler J. Adv Abortion Care. 1991.
65
Incorporating MVA Into Practice

• What does it take to incorporate the MVA
  procedure into a clinical practice?

66
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

67
MVA Patient Intake and Counseling
68
Contraindications to MVA

• First-trimester induced abortionNONE
• First-trimester spontaneous abortionNONE
• Completion of incomplete abortionNONE
• Suspected pregnancyendometrial biopsy should NOT
  be performed

Ipas. 2007.
69
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.
70
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.
71
Counseling for MVA

• Effective counseling occurs before, during, and
  after the procedure
• Woman-centered
• Structured completely around the womens 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
72
Counseling for MVA (continued)

• Prepare women for procedure-related effects
• Address womens 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
73
Counseling for MVA (continued)
Patient satisfaction with care
Quality of counseling
Picker Institute. 1999.
74
Post-Procedure Care

• Observe for complications
• Bleeding
• Pain
• Monitor pain and treat accordingly
• Monitor vital signs
• Check bleeding and pain

more
75
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.
76
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.
77
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

78
Contraception After MVA

• Ovulation may occur within 710 days post-MVA
• Dispense EC with instructions for use
• Can start hormonal contraceptives immediately
• Can insert IUD immediately post-procedure

more
79
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

80
Module 3Medication Abortion
81
Medication Abortion
Jones RK, Henshaw SK. Perspet Sex Reprod Health.
2002.
82
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.
83
Protocols Medication Abortion
RHEDI. Montifiore Medical Center. www.rhedi.org
84
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.
85
Medication Abortion Efficacy
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.
86
Medication Abortion Efficacy
200 mg oral mifepristone/600 mcg oral misoprostol
McKinley C, et al. Hum Reprod. 1993. Baird DT, et
al. Hum Reprod. 1995.
87
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.
88
Medication Abortion Efficacy
600 mg oral mifepristone/800 mcg vaginal
misoprostol
Schaff EA, et al. Contraception. 1999. el-Refaey
H, et al. N Engl J Med. 1995.
89
Medication Abortion Efficacy
200 mg oral mifepristone/800 mcg vaginal
misoprostol
Ashok PW, et al. Hum Reprod. 1998. Schaff EA, et
al. Contraception. 1999.
90
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.
91
Do Not Use in Women with

• Confirmed or suspected ectopic pregnancy
• IUD in place
• Long-term corticosteroid use
• Hemorrhagic disorders or inherited porphyrias

more
Danco Laboratories. 2005.
92
Do Not Use in Women with(continued)

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

Danco Laboratories. 2005.
93
Patient Intake Exercise
94
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.
95
Pain Management

• Ibuprofen or acetaminophen initially
• Oral narcotics if necessary

Grimes DA, Creinin MD. Ann Intern Med. 2004.
96
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

FDA. 2006.
97
Clostridium sordelli Infection

• Fever may not develop
• Consider other signs of infection
• Weakness
• Nausea
• Vomiting
• Diarrhea

FDA. 2006.
98
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

99
Contraception After Medication Abortion

• Ovulation may occur within 710 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.
100
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.
101
Module 4 Counseling Women on MVA Versus
Medication Abortion
102
Factors to Consider

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

103
Options for Terminating Pregnancy
Stewart FH, et al. 2004.
104
Efficacy of Abortion Options
Surgical and medication abortion are highly
effective
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.
105
Safety of Abortion
Surgical and medication abortion are low risk
Stewart FH, et al. 2004. Danco Laboratories.
2005. FDA. 2006. Green MF. N Engl J Med. 2005.
106
Expectations
Usually subside quickly
Grimes DA, Creinin MD. Ann Intern Med. 2004. NAF.
2006.
107
Location Where Abortion Occurs
NAF. 2006.
108
Time Required for Abortion
NAF. 2006.
109
Advantages of Abortion Options
Stewart FH, et al. 2004. NAF. 2006.
110
Disadvantages of Abortion Options
Stewart FH, et al. 2004. NAF. 2006.
111
Appendix
112
Expert Medical Advisory Committee
Herbert P. Brown, MD Clinical Associate
Professor of Ob/Gyn University of Texas Health
Science Center San Antonio, TX
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
more
113
Expert Medical Advisory Committee (continued)
Marji Gold, MD Professor of Family and Social
Medicine Albert Einstein College of
Medicine Bronx, NY
Jini Tanenhaus, PA, MA Associate Vice President,
Clinician Training Initiative Planned Parenthood
of New York City New York, NY