Miscarriage Management Training Initiative

Miscarriage Management Training Initiative
Management of Early Pregnancy Loss Sarah Prager, MD Department of Obstetrics and Gynecology University 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

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

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

Clarification We are not talking about elective abortion
We are teaching and promoting miscarriage management

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

Nomenclature Management of Early Pregnancy Loss
Early Pregnancy Loss (EPL) Spontaneous Abortion (SAb) Miscarriage These all mean exactly the same thing!

Background Management of Early Pregnancy Loss
Spontaneous Abortion (SAb) most common complication of early pregnancy — 8–20% clinically recognized pregnancies — 13–26% all pregnancies — ~ 800,000 SABs each year in the US 80% of SAbs occur in 1st trimester Studies show substantial percentage of pregnancies are lost prior to being clinically recognized.

Samantha 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. Case study to follow through the presentaion

Risk Factors Management of Early Pregnancy Loss
Prior SAb Smoking Alcohol Caffeine (controversial) Maternal BMI <18.5 or >25 Celiac disease (untreated) Cocaine NSAIDs High gravidity Fever Low folate levels NSAIDs taken at time of conception Fever in calendar month of conception Folate low only in cases with aneuploid fetuses/embryos

Etiology Management 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 & Development Management of Early Pregnancy Loss
Implantation: — 5-7 days after fertilization — Takes ~72 hours — Invasion of trophoblast into decidua 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 Pregnancy Management of Early Pregnancy Loss
Mean Sac Diameter (mm) + 30 OR Crown-Rump Length (mm) + 42 = Gestational Age (days)

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

Ultrasound Findings of EPL Management of Early Pregnancy Loss
Anembryonic Pregnancy — No fetal pole with mean sac diam >25 mm (transabdominal) OR >18 mm (transvaginal) — <4 mm growth in 7 days (No yolk sac, with mean sac diameter >10 mm) Embryonic Demise — No cardiac activity with CRL ≥5 mm Yolk sac designation is softer call. Mishell DR, Comprehensive Gynecology 2007

Samantha 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 Options Early Pregnancy Loss
Do Nothing: Expectant management Do Something: Medical management Do Surgery: Surgical management Sotiriadis A, Obstet Gynecol 2005 Nanda K, Cochrane Database Syst Rev 2006

Do Nothing Expectant Management
Requirements for therapy: — <13 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 post-diagnosis

Outcomes Do 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 Many studies define failure as an endometrial thickness of 15 mm at some defined point in time

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 (7.6–29 mm) — At one week 15% with ET >16 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 2001 Reynolds A, Eur. J Obstet Gynecol Reproduct. Biol 2005

When to intervene for Expectant Management?
Continued gestational sac Clinical symptoms Patient preference Time (?) Vaginal bleeding and positive UPT are possible for 2–4 weeks — Poor measures of success

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

Do Something Medical Management
Misoprostol Misoprostol + Mifepristone Misoprostol + Methotrexate No medical regimen for management of EPL is FDA approved

Medical Management Requirement for Therapy
<13 weeks gestation Stable vital signs No evidence of infection No allergies to medications used Adequate counseling and patient acceptance of side effects

Misoprostol 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/treatment 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 It’s a great option for women who want to do something, but avoid surgery

Misoprostol Dosing Regimens Embryonic 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 Multiple different doses and routes of administration have been studied, as well as single versus multiple dose regimens. 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 Dosing Incomplete Abortion
Study N Dose vs. Results Weeks et al, ‘ oral d1,2 MVA 96.3% in 1–2 wks Moodliar et al, ‘ vag D&C 91.5% in 1 wk Zhang et al, ‘05* vag d1,3 D&C 84% in 8 days Coughlin et al, ‘ oral x 2 78% 1 dose/ % ultimately Ngai et al, ‘ vag d1,3,5 observe 83% by day 15 Pang et al, ‘ oral 65% in 24 hrs vaginal 61% in 24 hrs Demetroulis, ‘01* vaginal D&C 93% in 8-10 hrs Chung et al, ‘ oral q4h D&C 50% Chung et al, ‘ oral tid D&C 50% Chung et al, ‘ oral q4h 50% Weeks, 5 pts in MVA arm > 13 weeks classified as failures so non sig difference of 91.5% success *also included missed abortions

Pooled Outcomes Medical Management
Success Rates Placebo 16–60% Single dose misoprostol 25–88% 400–800 mcg Repeat dose x 1 if incomplete 80–88% at 24 hours Success rate depends on type of miscarriage — 100% with incomplete abortion — 87% for all others Wood SL, Obstet Gynecol 2002; Bagratee JS, Hum Reproduct 2004; Blohm F, BJOG: Int J Obstet Gynecol 2005

Serum Level Comparison Misoprostol by Route of Administration
Of course, not ideal to compare separate studies…The buccal serum level curve was very similar to vaginal curves in all prior studies, with a slow rise to peak and sustained levels over several hours.

Uterine Tone Over 5 Hours Misoprostol by Route of Administration
Mean vag moist beginning increase at 17 min, vag dry 29 min Rectal p = .006 Meckstroth, not yet published

Uterine Activity Over 5 Hours Misoprostol by Route of Administration
Meckstroth, not yet published

Side Effects and Complications Misoprostol vs. Placebo
N/V, Diarrhea: No difference Pain: More pain and analgesics in one study Hemoglobin Conc: No difference Infection: 0% for placebo vs –4.7% for misoprostol No benefit with repeat dosing within 3–4 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 Line Medical Management
800 mcg pv (or buccal) Repeat x 1 at 12–24 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: mg mifepristone mcg misoprostol Success rates for mifepristone & misoprostol in EPL: — 52–84% (observational trials, non-standard dose) — 90–93% (standard dose) No direct comparison between misoprostol alone and mifepristone/misoprostol with standard dosing Mifepristone may help (data still pending) Why not just add mife? Expensive, less available. Gronlund A, Acta Obstet Gynaecol 1998; Nielsen S, Br J Obstet Gynaecol 1997; Niinimaki M, Fertility Sterility 2006; Schreiber CA, Contraception 2006 37

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 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?

Samantha 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 nausea. Her ultrasound shows a uniform endometrial stripe measuring 30mm in its greatest width. Is she complete?

Samantha

Rebecca 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 D&C.

Rebecca What questions would you ask to see if she was a good candidate? Everyone is a candidate for surgical management, basically. The real question is whether or not she is a candidate for outpatient management.

Surgical Management Early Pregnancy Loss
Suction dilation and curettage (D&C) Who should have surgical management? — Unstable — Significant medical morbidity — Infected — Very heavy bleeding — Anyone who WANTS immediate therapy

Surgical Management Early Pregnancy Loss
BENEFITS RISKS Convenient timing Observed therapy High success rates (almost 100%) Infection (1/200) Perforation (1/2000) Cervical trauma Uterine synechiae (very rare)

Infection Prophylaxis Surgical Management
Periabortal antibiotics  infection risk 42% No strong evidence on what to use Doxycycline (2–14 doses) Metronidazole: — Bacterial vaginosis — Trichomoniasis — Suspicious discharge Sawaya GF, Obstet Gynecol 1996; Prieto JA, Obstet Gynecol 1995

Comparison of Outcome by Method Management of Early Pregnancy Loss
Factor Comparison of Methods Success rate Surgical > Medical Medical ≥ Expectant Resolution Surgical > Medical > Expectant within 48 hrs Infection risk Expectant = Medical = Surgical .2–3% 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 Satisfaction Management 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 % satisfied — If women chose % satisfied — Both were independent of method Unsuccessful expectant resulting in surgical showed most profound anxiety and depression Sotiriadis 2005

Patients randomly assigned to miso vs. D&C
Zhang, NEJM 2005

Cost Analysis Management of Early Pregnancy Loss
Medical management most cost effective — 2 studies — Misoprostol vs. expectant vs. surgical: $ vs. $ vs. $2007 Expectant management most cost effective — MIST trial — Expectant vs. medical vs. surgical: £ vs. £ vs. £1585 Doyle NM, Obstet. Gynecol 2004; You JH, Hum Reprod 2005; Petrou S, BJOG 2006

Rebecca Refer to OR? Manage with MVA? The clinic schedule is packed…does this have to be done today?

Where to perform? Surgical Management
Women with SAb in Canada: — 92.5% presenting to hospital have D&C — 51% presenting to family physician have D&C 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

Advantages Moving Rx from OR to Outpatient Setting
Avoid repeated exams that often occur in hospital 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 CORE SLIDE NPO means nothing by mouth (fasting requirements). Providing miscarriage management in the office has benefits for both the patient and the clinician. Avoidance of repeated exams: When women present to the emergency room (ER) with signs and symptoms of a miscarriage, they may be put through many pelvic exams (first the ER resident, then the ER attending, often followed by the gyn resident and then the gyn attending—none of whom are usually the woman’s own physician). In a clinic setting, the woman usually undergoes one exam--by her own doctor, midwife, or nurse practitioner. Long waits in the hospital: Women undergoing miscarriages are usually not acutely ill. Both in the emergency room as well as in the operating room, they usually receive care only after sicker patients have already been treated. Patients who received care in the hospital reported dissatisfaction with the fact that “miscarriage was not perceived by medical staff as important or an emergency” (Lee 1996). Women do not like these long waits. Impersonal, mechanized environment in the operating room: The operating room environment is extremely high-tech and mechanized. Patients undergoing procedures in the operating room must adhere to strict protocols; this can be frustrating and intimidating for patients. Source: Lee C, Slade P. Miscarriage as a traumatic event: a review of the literature and new implications for intervention. J Psychosom Res 1996;40(3):235–244. Demetroulis 2001; Lee and Slade 1996 53

Advantages Moving Rx from OR to Outpatient Setting
Office affords more treatment options — Vacuum aspiration or misoprostol — Pain management choices Improved patient autonomy and privacy Convenience Personalized care CORE SLIDE Women treated in the outpatient setting are usually in a more familiar and private setting than that of the operating room. Many women undergoing early pregnancy failure value education about what they are currently experiencing and what is likely to happen. Opportunities to answer related questions may be better in the outpatient setting. Miscarriage patients treated in the hospital reported dissatisfaction with the limited amount of education received regarding medical aspects such as what to expect regarding vaginal bleeding, when to resume sexual intercourse, and when contraception could be initiated (Lee and Slade 1996). In Lee and Slade’s paper summarizing women’s experiences in hospital-based miscarriage management, women complained about the following aspects of hospital care: Staff attitudes—“insensitive and unsympathetic” Accommodations—miscarriage patients are sometimes put right next to women in labor or undergoing an induced abortion. This can be upsetting. Resident involvement—some women preferred to avoid resident involvement in their care, though residents are often an integral part of service delivery in hospitals. Source: Lee C, Slade P. Miscarriage as a traumatic event: a review of the literature and new implications for intervention. J Psychosom Res 1996;40(3):235–244. Lee and Slade 1996 54

Moving Incomplete Abortion to Outpatient Setting Johns Hopkins Study
Methods N = 35, incomplete 1st-trimester abortion Treatment comparison: Procedure: Setting: Manual Conventional vacuum care aspiration (suction (MVA) curretage) L&D OR CORE SLIDE This U.S.-based study out of Johns Hopkins demonstrates how providing miscarriage management in an outpatient setting offers many benefits. Thirty-five women with incomplete abortions presenting to the emergency room received either MVA in labor and delivery or traditional care with suction curettage in the operating room. If the woman was to be managed in the operating room but no rooms were available, she was sent to the gynecology floor until the OR became available. Source: Blumenthal PD, Remsburg RE. A time and cost analysis of the management of incomplete abortion with manual vacuum aspiration. Int J Gynecol Obstet 1994;45: vs. Blumenthal and Remsburg 1994 55

Moving Incomplete Abortion to Outpatient Setting Johns Hopkins Study
Results  Anesthesia requirements  Overall hospital stay, from hours  Patient waiting time by 52%  Procedure time, from minutes  Costs per case: $1,404 in OR $827 in L&D $200 or less in ER CORE SLIDE The MVA-based procedures resulted in significant savings in: Patient waiting time Cost—only three patients received care in the ER, so the cost number may not be as reliable as the others. Anesthesia requirements—most women undergoing management in the operating room received higher doses of intravenous sedation given by an anesthesiologist. Women undergoing MVA received local anesthesia with lighter intravenous sedation. Procedure time was thought to be reduced because the products of conception were immediately available to look at when using MVA, as opposed to having to take the tubing apart to inspect the POC when using EVA. There were no procedural complications in either group (although the study was not designed as a safety/efficacy study). Source: Blumenthal PD, Remsburg RE. A time and cost analysis of the management of incomplete abortion with manual vacuum aspiration. Int J Gynecol Obstet 1994;45: Blumenthal 1994 56

Use Outpatient Management Cautiously in Women with…
Uterine anomalies Coagulation problems Active pelvic infection Extreme anxiety Any condition causing patient to be medically unstable CORE SLIDE Before uterine aspiration, any life-threatening conditions should be addressed immediately. Life-threatening conditions include: shock, hemorrhage, cervical or pelvic infection, sepsis, perforation, or abdominal injury as may occur with incomplete abortion or with clandestine abortion. Uterine aspiration with MVA is often an important component of definitive management in these cases, and once the patient is stabilized, the procedure should not be delayed. Source: Ipas Gynecological Aspiration System. MVA Label. U.S. English. 2004 57

What Is a Manual Vacuum Aspirator?
Options for Early Pregnancy Loss: MVA and Medication Management What Is a Manual Vacuum Aspirator? Locking valve Portable and reusable Equivalent to electric pump Efficacy same as electric vacuum (98%–99%) Semi-flexible plastic cannula Talking Points Using a 60-mL receptacle, the aspirator provides identical suction pressure (26 inches of mercury) to an electric pump until approximately 80% capacity. The aspirator can be quickly emptied and reused if more capacity is needed. It is portable and small. These qualities make it very practical for a variety of settings, including an office, emergency room, and hospital-based location. NOTE TO SPEAKER: Hold up the instrument here and demonstrate vacuum on a finger or palm of hand. Explain that vacuum is produced by locking the valves, which seals off one end of the aspirator, and then withdrawing the plunger. References Creinin MD, Schwartz JL, Guido RS, Pymar HC. Early pregnancy failure—current management concepts. Obstet Gynecol Surv. 2001;56(2):105–13. Goldberg AB, Dean G, Kang MS, Youssof S, Darney P. Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates. Obstet Gynecol. 2004;103:101–7. Hemlin J, Moller B. Manual vacuum aspiration, a safe and effective alternative in early pregnancy termination. Acta Obstet Gynecol Scand. 2001;80:563–67. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Creinin MD, et al. Obstet Gynecol Surv ; Goldberg AB, et al. Obstet Gynecol Hemlin J, et al. Acta Obstet Gynecol Scand 58 Slide 58

Decreases to 80% (50 mL) as aspirator fills
Options for Therapeutic Abortion: Aspiration Versus Medication Comparison EVA to MVA EVA MVA Vacuum Electric pump Manual aspirator Noise Variable Quiet Portable Not easily Yes Cannula 4–16 mm 4–12 mm Capacity 350–1,200 cc 60 cc Suction Constant Decreases to 80% (50 mL) as aspirator fills Talking Points Implications of being quiet: Perceived as a benefit by some patients (see Dean study summarized below). Improves patient-provider rapport. Improves provider’s ability to “hear” the procedure (the grittiness sometimes has a sound). Reduces patient noise-imprinting. A study done at the University of California, San Francisco investigated the acceptability of MVA vs. EVA and tried to quantify the impact of noise on women undergoing vacuum aspiration (Dean 2003). The study included 84 women undergoing abortion at less than 10 weeks of gestation. There was no significant difference in patient satisfaction, although significantly more women in the EVA group were bothered by noise (19% vs. 2%; P = 0.03). There were significantly more times in the EVA group that physicians would have preferred manual aspiration (43% vs. 17%; P = 0.02); this usually applied to early pregnancies. Reference Dean G, Cardenas L, Darney P, Goldberg A. Acceptability of manual versus electric aspiration for first trimester abortion: a randomized trial. Contraception. 2003;67 201–6. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Dean G, et al. Contraception 59 Slide 59

Clinical Indications for MVA
Options for Therapeutic Abortion: Aspiration Versus Medication Clinical Indications for MVA Uterine evacuation in the first trimester: Induced abortion Spontaneous abortion Incomplete medication abortion Uterine sampling Post-abortal hematometra Hemorrhage Talking Points According to Ipas product labeling, clinical indications for uterine aspiration with MVA are: Treatment of incomplete abortion for uterine sizes up to 12 weeks since last menstrual period (LMP) First-trimester abortion Endometrial biopsy (should not be performed in cases of suspected pregnancy) There are no known contraindications for other clinical indications. MVA is also being used for the following: Spontaneous abortion, including missed, inevitable, and incomplete abortion Induced abortion As a backup to medication abortion Post-abortal hematometra Uterine sampling with MVA is especially useful in the clinic setting when a woman presents with a significant amount of bleeding. In such cases, the pipelles that are usually used for endometrial biopsies are too small. Instead, MVA can be used to fully evacuate the clot and sample underlying tissue. If using MVA beyond 12 weeks, a provider should do so, but should know this use is not approved by the Food and Drug Administration. References Creinin MD, Schwartz JL, Guido RS, Pymar HC. Early pregnancy failure—current management concepts. Obstet Gynecol Surv. 2001;56(2):105–13. Edwards J, Creinin MD. Surgical abortion for gestation of less than 6 weeks. Curr Probl Obstet Gynecol Fertil. 1997;20 (1):11–19. Castleman LD, Oanh KT, Hyman AG, Thuy le T, Blumenthal PD. Introduction of the dilation and evacuation procedure for second-trimester abortion in Vietnam using manual vacuum aspiration and buccal misoprostol. Contraception Sep;74(3):272-6. MVA Label, United States, English. Ipas - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Creinin MD, et al. Obstet Gynecol Surv ; Edwards J, Creinin MD. Curr Probl Obstet Gynecol Fertil.1997.; Castleman LD et al. Contraception. 2006; MVA Label. Ipas Slide 60

Options for Therapeutic Abortion: Aspiration Versus Medication
MVA Instruments Talking Points This slide shows supplies needed to perform MVA procedures. The aspirator shown on the right is a double-valve syringe. Refer to directions for use with each manufacturer’s product. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Slide 61

Steps for Performing MVA
Options for Therapeutic Abortion: Aspiration Versus Medication 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). . .” Talking Points Instrument preparation is the first step in MVA procedures, followed by preparation of the patient. Follow the instructions provided by the manufacturer. With the speculum inserted, hold the cervix steady with a tenaculum and gently apply traction to straighten the cervical canal. Introduce the cannula gently through the cervical os into the uterine cavity. Attach the cannula to the prepared aspirator. Release the button on the aspirator to transfer the vacuum through the cannula into the uterus. Blood tissue and bubbles should begin to flow through the cannula into the aspirator. Evacuate the contents of the uterus by rotating the cannula 180 degrees in each direction while using a gentle in-and-out motion. Refer to product insert if the cannula fills or becomes clogged. The uterus is empty when: Red or pink foam without tissue is seen passing through the cannula; and A gritty sensation is felt as the cannula passes over the surface of the evacuated uterus; and The uterus contracts around (grips) the cannula; and The patient notes pain as the uterus contracts. Empty the contents of the aspirator into an appropriate container. Inspect aspirated tissue for POC. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Slide 62

Complications with MVA
Options for Therapeutic Abortion: Aspiration Versus Medication Complications with MVA Very rare Same as EVA May include: — Incomplete evacuation — Uterine or cervical injury — Infection — Hemorrhage — Vagal reaction Talking Points Complications of MVA are the same as those that may result from EVA. FDA warnings on Ipas’s MVA label are: Incomplete evacuation Uterine or cervical injury or perforation Pelvic infection Acute hematometra Vagal reaction In an interactive setting, the trainer may wish to incorporate some of the cases listed on the Word document entitled “MVA Cases for Discussion” with the accompanying key. Complications are covered in cases 5, 7, and 8. The other cases listed pertain to general clinical issues of MVA. Reference MVA Label, United States, English. Ipas - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at MVA Label. Ipas 63 Slide 63

MVA vs. EVA Complication Rates
Options for Early Pregnancy Loss: MVA and Medication Management 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 Talking Points This study looked at rates for complications such as re-aspiration and perforation. The study is important because of its sample size. Abortion-related problems are uncommon; research on complications requires a large sample size. The sample size calculation used revealed that Goldberg’s study had the power to detect a 2% difference in re-aspiration rates between MVA and EVA. All of these cases were performed in the same outpatient clinic setting. In this study, most women received moderate sedation with fentanyl and midazolam. Both EVA and MVA were readily available in the room with patients; the choice of method was up to the physician. *Elective not spontaneous studies Reference Goldberg AB, Dean G, Kang MS, Youssof S, Darney PD. Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates. Obstet Gynecol. 2004;103:101–7. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at more… Goldberg AB, et al. Obstet Gynecol Slide 64

MVA vs. EVA Complication Rates (continued)
Options for Early Pregnancy Loss: MVA and Medication Management MVA vs. EVA Complication Rates (continued) Complications 2.5% for MVA 2.1% for EVA (p = 0.56) No significant difference Talking Points Complications seen were re-aspirations and perforation. Reference Goldberg AB, Dean G, Kang MS, Youssof S, Darney PD. Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates. Obstet Gynecol. 2004;103:101–7. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at *Elective not spontaneous studies more… Goldberg AB, et al. Obstet Gynecol Slide 65

MVA vs. EVA Complication Rates (continued)
Options for Early Pregnancy Loss: MVA and Medication Management MVA vs. EVA Complication Rates (continued) Choice of MVA vs EVA in procedures Attendings: 52% MVA Gyn residents: 59% MVA Other residents: 76% MVA (p<0.001) Talking Points The clinicians had the choice of whether to use MVA or EVA, because both were always in the clinic room and readily available. Attending physicians chose MVA 52% of the time, gyn residents chose MVA 59% of the time, and other residents chose it 76% of the time. The authors believed the difference reflected differences in previous experience and comfort level with new technology: attending physicians had more previous experience with EVA, residents had more experience with MVA. Reference Goldberg AB, Dean G, Kang MS, Youssof S, Darney PD. Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates. Obstet Gynecol. 2004;103:101–7. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Goldberg AB, et al. Obstet Gynecol Slide 66

MVA and POC: Study In group overall
Options for Early Pregnancy Loss: MVA and Medication Management 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 Talking Points These data come from the study from UCSF detailed earlier, which compared complication rates of MVA and EVA. There were 1,726 patients included in the study, of whom 37 were at less than 6 weeks of gestation. Both MVA and EVA were readily available in the procedure rooms; the clinician could choose to use either one. There were no re-aspirations among these 37 early cases, though the study was not specifically designed to look at this early group. In the entire group (up to 10 weeks of gestation), there were significantly more re-aspirations in the electric group for inability to accurately identify the pregnancy. The study’s authors commented that this trend may be especially important for women whose pregnancies were less than 6 weeks, though they did not have enough patients in this category to adequately address this question. It is interesting to note that in 35 of 37 procedures, the physician performing these very early procedures chose MVA over EVA. *Elective not spontaneous studies Reference Goldberg AB, Dean G, Kang MS, Youssof S, Darney PD. Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates. Obstet Gynecol. 2004;103:101–7. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at more… Goldberg AB, et al. Obstet Gynecol Slide 67

MVA and POC: Study (continued)
[Insert Lecture Name Here] MVA and POC: Study (continued) “…Significantly more re-aspirations for inability to accurately identify the pregnancy occurred in electric group.” - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Goldberg AB et al. Obstet Gynecol, 2004 Goldberg AB, et al. Obstet Gynecol Slide 68

Early Abortion with MVA: Study
Options for Therapeutic Abortion: Aspiration Versus Medication 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 Talking Points The demand for early abortion has increased with the availability of home pregnancy tests as well as medication abortion. However, studies from the 1970s suggested that earlier procedures were associated with a higher failure rate. Beginning in 1994, Planned Parenthood of Houston and Southeast Texas developed a protocol to challenge the dictum that abortion before 6 weeks of gestation had greater risks. Edwards and Creinin examined the data for abortions performed from January 1994 through July This was a significant study in that it prompted many clinicians to start providing vacuum aspiration abortions earlier in gestation. Study methods and results: 2,399 MVA procedures were performed for women at or before 6 weeks of gestation 2,379 (99.2%) patients had complete abortions (defined as no other intervention needed) 6 women required repeat aspiration (0.25%) –3 for hematometra –3 for continuing pregnancies 14 women had ectopic pregnancies (0.6%) that were diagnosed and treated No other complications were experienced Follow-up rate not reported but “probably low” (per Paul 2002; see next slide for full reference) Reference Edwards J, Creinin MD. Surgical abortion for gestations of less than 6 weeks. Curr Probl Obstet Gynecol Fertil. 1997;20:11–19. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Edwards J, Creinin MD. Curr Probl OIbstet Gynecol Fertil Slide 69

Products of Conception (POC)
Options for Early Pregnancy Loss: MVA and Medication Management Products of Conception (POC) Procedure is complete when POC are identified Electric Suction Machine MVA Aspirator Talking Points Note: Tissue after an early pregnancy loss may not look as intact as the POC shown here, which shows tissue from an elective abortion. MVA “may cause less disruption of evacuated uterine contents and facilitate identification of products of conception” (POC) (Dean 2003), which is especially important for abortions performed at an early gestational age. With the ability to identify POC and the availability of sensitive pregnancy tests plus transvaginal ultrasound, we have the means to make early vacuum aspiration both safe and effective. As the photo conveys, for early gestational ages, POC may be easier to identify using MVA rather than EVA. This is important in order to confirm completion of procedures. Equipment needed for POC identification (depending upon the participants’ specific goals, the trainer should consider having the following available to show to the group): Receptacle for POC Shallow bowl Mesh strainer Forceps Light source (or describe) For interactive settings, review preconceptions and barriers listed on flipchart from the previous exercise and ensure that misconceptions have been clarified. Consider posting this statement on flipchart. References Edwards J, Carson SA. New technologies permit safe abortion at less than six weeks’ gestation and provide timely detection of ectopic gestation. Am J Obstet Gynecol. 1997;176(5):1101–6. MacIsaac L, Darney P. Early surgical abortion: an alternative to and backup for medical abortion. Am J Obstet Gynecol. 2000;183(2 Suppl):S76–S83. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Edwards J, et al. Am J Obstet Gynecol MacIsaac L, et al. Am J Obstet Gynecol Slide 70

Patient Satisfaction Both EVA and MVA groups were highly satisfied
Options for Therapeutic Abortion: Aspiration Versus Medication 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 Talking Points Bird et al.: Multicenter US trial of women seeking first-trimester abortion Patients were prospectively randomly assigned to either MVA (n = 64) or EVA (n = 63) Results showed no difference in patients’ reports of pain, anxiety, or bleeding, or in the acceptability of each method Both groups were highly satisfied, would choose their abortion method in the future, and would recommend it to a friend Dean et al.: University of California, San Francisco N = 84 women requesting abortion at < 10 weeks of gestation, randomly assigned to either MVA or EVA No difference found in pain levels or satisfaction. Women in both groups were treated with similar amounts of intravenous fentanyl and midazolam. More EVA patients (19%) than MVA patients (2%) were bothered by noise (P = 0.03). Edelman et al.: Planned Parenthood, Portland N = 114 < 11 weeks of gestation Women were randomly assigned to either MVA or EVA Patients assessed pain level with visual analog scales Patients’ reports of pain did not differ by procedure References Bird ST, Harvey SM, Beckman LJ, Nichols MD, Rogers K, Blumenthal PD. Similarities in women’s perceptions and acceptability of manual vacuum aspiration and electric vacuum aspiration for first trimester abortion. Contraception. 2003;67:207–12. Dean G, Cardenas L, Darney P, Goldberg A. Acceptability of manual versus electric aspiration for first trimester abortion: a randomized trial. Contraception. 2003;67:201–6. Edelman A, Nichols MD, Jensen J. Comparison of pain and time of procedures with two first-trimester abortion techniques performed by residents and faculty. Am J Obstet Gynecol. 2001;184(7):1564–7. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Bird ST, et al. Contraception ; Dean G, et al. Contraception ; Edelman A, et al. Am J Obstet Gynecol Slide 71

MVA Safety and Efficacy: Summary
Options for Early Pregnancy Loss: MVA and Medication Management 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 guidelines) Talking Points This slide can be used to review “take-home messages” from the studies just reviewed. The set-up is very simple, as shown by this tray. Although the procedure is easily incorporated into an office setting, there are definitely training issues involved. Before providing the procedure, the clinician should receive training in topics such as: Pain management with an awake patient Ultrasound as needed (lack of ultrasound in the immediate office setting should not become a barrier to service provision) No sharp curettage required Patient-provider interaction Identification of products of conception New Instructions for instrument processing, if the devices are to be reused, can be found in the product insert. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Slide 72

Rebecca 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
Options for Early Pregnancy Loss: MVA and Medication Management MVA and Pain Pain is made worse by: Fearfulness Anxiety Depression Talking Points A current model of pain: Perception involves both emotions and sensation. Perception of pain is dependent on the context in which it occurs. Paying attention to pain increases the sensation, whereas being distracted from pain lessens the sensation. Fear increases pain; addressing anxiety and providing psychological support reduce pain. How does this model of pain apply to MVA? Women undergoing abortion are often fearful about pain. We know that psychological factors have a strong impact on how much pain women seem to experience during uterine evacuation. It’s important to address psychological factors to reduce pain. References Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989;36:339–50. Smith GM, Stubblefield PG, Chirchirillo L, McCarthy MJ. Pain of first trimester abortion: its quantification and relations with other variables. Am J Obstet Gynecol. 1979;133(5):489–98. Hansen GR, Streltzer J. The psychology of pain. Emerg Med Clin N Am. 2005;23:339–48. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Belanger E, et al. Pain ; Smith GM, et al. Am J Obstet Gynecol Hansen GR, Streltzer J. Emerg Med Clin N Am Slide 74

Effective Pain Management
Options for Early Pregnancy Loss: MVA and Medication Management Effective Pain Management Respectful, informed, and supportive staff Warm, friendly environment Gentle operative technique Women’s involvement Effective pain medications Talking Points The following can help ensure effective pain management during MVA procedures: Respectful, informed, and supportive staff Warm, friendly environment Gentle operative technique Women’s involvement Effective pain medications - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Slide 75

Pain Management Techniques
Options for Early Pregnancy Loss: MVA and Medication Management Pain Management Techniques With addition of: Focused breathing: 76% Visualization: 31% Localized massage: 14% General or nitrous 10% 32% 58% Talking Points This slide shows pain control techniques used by National Abortion Federation (NAF) clinics (Lichtenberg et al. 2001). This is a particularly helpful slide in locations where the group feels that “their patients will only tolerate general anesthesia.” In general, NAF clinics provide high-quality abortion care and strive to make sure that their customers are satisfied. Pain management matters a lot to women. The fact that the majority of NAF clinics offer local anesthesia as a primary method of pain control strongly implies that many women use this option. This slide can also be used to make the point that ancillary methods of pain management, such as focused breathing, visualization, and massage, are important. Music may also be helpful in reducing pain perception. A study of the effect of music and relaxation after gynecological surgery found that both interventions significantly reduced the reported level of pain (Good et al. 2002). References Lichtenberg ES, Paul M, Jones H. First trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2001;64:345–52. Good M, Anderson GC, Stanton-Hicks M, Grass JA, Makii M. Relaxation and music reduce pain after gynecologic surgery. Pain Manag Nurs. 2002;3:61–70. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Local + IV Local Lichtengerg ES, et al. Contraception Good M, et al. Pain Manag Nurs Slide 76

Efficacy of Ancillary Anesthesia
Options for Early Pregnancy Loss: MVA and Medication Management 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 Talking Points Residency programs in the United States often do not emphasize ancillary techniques of pain management for procedures on awake patients. Dentists have known for a long time that if patients hear music through headphones and are otherwise treated nicely while they have their teeth drilled, the patients feel less pain. In a study from the University of Miami in 1974, 144 women undergoing first-trimester abortion with suction curettage, oral valium, and paracervical block were randomly assigned to 1) standard technique, 2) headphones with music, or 3) self-administered methoxyflurane. The group using the headphones had less than half the incidence of pain of the other two groups: 85% of the group with headphones said they had no pain, compared with 52% of the other two groups. Pre-procedure fearfulness appears to play a major role in the amount of pain women perceive. Stubblefield noted that women who know what to expect through better education and psychological preparation tend to be less afraid, which may be associated with reduced pain. References Shapiro AG, Cohen H. Auxiliary pain relief during suction curettage. Contraception. 1975;11(1):25–30. Stubblefield PG. Control of pain for women undergoing abortion. Suppl Int J Gynecol Obstet. 1989;3:131–40. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Shapiro AG, Cohen H. Contraception Stubblefield PG.Suppl Int J Gynecol Obstet Slide 77

Paracervical Block Deep Injection Regular Injection
Options for Therapeutic Abortion: Aspiration Versus Medication Paracervical Block Deep Injection Regular Injection Talking Points Paracervical block is commonly used for vacuum aspiration abortions in North America. However, clinicians use many different techniques for administering a paracervical block. “There is a little science and a lot of art in this area” (Maltzer et al. 1999, p. 77). Studies have shown that deep injections using the Glick technique can be more effective than superficial injections and that injecting slowly has been found to be less painful than injecting quickly. The trainer may want to be prepared to discuss techniques for administering a paracervical block, because this is a very commonly asked question. Approaches and evidence are discussed fully in the sources listed below. References Castleman L, Mann C. Manual Vacuum Aspiration (MVA) for Uterine Evacuation: Pain Management. Chapel Hill, NC: Ipas, 2002. Maltzer DS, Maltzer MC, Wiebe ER, Halvorson-Boyd G, Boyd C. Pain management. In: NAF’s A Clinician’s Guide to Medical and Surgical Abortion. Philadelphia: Churchill Livingstone, 1999. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Castleman L, Mann C Maltzer DS, et al Slide 78

Sharp Curettage and Pain
Options for Early Pregnancy Loss: MVA and Medication Management Sharp Curettage and Pain Often requires increased dilatation Often painful More difficult to reduce anesthesia Talking Points Studies on incomplete abortion reveal that suction causes less pain than sharp curettage. Reference Forna F, Gulmezoglu AM. Surgical procedures to evacuate incomplete abortion (Cochrane Review). In: The Cochrane Library 2002; Issue 1. Oxford: Update Software. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Forna F, Gulmezoglu AM. Cochrane Library Slide 79

Sharp Curettage and MVA
Options for Early Pregnancy Loss: MVA and Medication Management Sharp Curettage and MVA Generally not indicated Not routinely recommended after MVA Talking Points Sharp curettage is generally not indicated and is not routinely recommended after MVA. Reference WHO. Safe Abortion: Technical and Policy Guidance for Health Systems. Geneva, Switzerland: World Health Organization, 2003. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at more… WHO. 2003 Slide 80

Ultrasound and MVA Not required for MVA
Options for Therapeutic Abortion: Aspiration Versus Medication Ultrasound and MVA Not required for MVA Used by some providers routinely Use contingent on provider preference and experience Talking Points MVA is simple and portable and can be easily integrated into an office practice. Although many training centers routinely use ultrasound, lack of ultrasound should not prevent clinicians from offering MVA to women. MVA is practiced safely and effectively in many settings that do not have ultrasound. Reference WHO. Safe Abortion: Technical and Policy Guidance for Health Systems. Geneva, Switzerland: World Health Organization, 2003 - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Word Health Organization Slide 81

Options for Early Pregnancy Loss: MVA and Medication Management
Counseling for MVA Effective counseling occurs before, during, and after the procedure Prepare women for procedure-related effects Address women’s concerns about future desired pregnancies Talking Points Adequately preparing women for possible procedure-related effects expected with abortion is a critical component of counseling. Counseling tips can be found in the reference manual by Alyson Hyman. Adequate counseling about the likely severity of effects and anticipatory guidance about their management may result in fewer calls for reassurance from women. Women may be concerned about the effect of abortion on future desired pregnancies. It is important to provide them with accurate information: First-trimester aspiration abortion does not affect subsequent fertility, nor does it increase the risk of miscarriage or preterm delivery. Similar data are not yet available for medication abortion, but the fact that it is less invasive than aspiration is reassuring. References Breitbart V, Repass DC. The counseling component of medical abortion. J Am Med Womens Assoc. 2000;55(suppl 3):164–6. Hogue CJ, Cates W, Jr., Tietze C. The effects of induced abortion on subsequent reproduction. Epidemiol Rev. 1982;4:66–94. Stewart FH, Ellertson C, Cates W, Jr. Abortion. In: Hatcher RA, Trussell J, Stewart F, et al., eds. Contraceptive Technology, 18th edition. New York: Ardent Media, Inc.; 2004. Hyman AG, Castleman L. Woman-Centered Abortion Care: Reference Manual. Chapel Hill, NC: Ipas - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at more… Breitbart V, Repass DC. J Am Med Womens Assoc ; Hogue CJ, et al. Epidemiol Rev. 1982; Steward FH, et al Hyman AG, Castleman L. 2005 Slide 82

Rebecca Rebecca is scheduled for a uterine aspiration with MVA procedure during the next procedure clinic. The procedure is uncomplicated and her questions include: Can I get pregnant right away? Am I at risk for another miscarriage?

Future Miscarriage Risk
43% 28% 20%

Counseling for MVA (continued)
Options for Therapeutic Abortion: Aspiration Versus Medication Counseling for MVA (continued) Patient satisfaction with care Quality of counseling Talking Points Adequate counseling ensures that women have the information and support they need to complete all aspects of the procedure. In addition, a study published by the Picker Institute indicated that women’s feelings about the abortion counseling they received correlated positively with their satisfaction with the procedure. It should be noted that of the 2,215 women interviewed for this study, only 37 (1.7%) had a medication abortion. Reference Picker Institute. From the Patient’s Perspective: Quality of Abortion Care [survey]. Menlo Park, CA: Henry J Kaiser Family Foundation; 1999. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Picker Institute Slide 85

Postmiscarriage Care Management 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 2–4 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
Options for Therapeutic Abortion: Aspiration Versus Medication 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 Talking Points As part of instructions for aftercare, women should be told when to contact the clinician after an abortion procedure. These indications include: Bleeding that is becoming heavier and causing any dizziness or lightheadedness. Usually vaginal bleeding gets lighter over time. Heavy bleeding is soaking two or more maxi-pads per hour for more than 2 hours. Pain that is worsening, especially if it is not improved with ibuprofen. Fever or chills. Flu-like symptoms that last more than 24 hours. Syncope. Any questions. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in December Original funding received from Ipas and the John Merck Fund through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for the Manual Vacuum Aspiration Education Partnership Project in October This slide is available at Slide 87

For more information on EPL
Association of Reproductive Health Professionals (ARHP) archived webinar: Options for Early Pregnancy Loss: MVA and Medication Management Ipas WomanCare Kit for Miscarriage Management

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