1. Medication Abortion in Early Pregnancy
Induced termination of early intrauterine pregnancy using medications

2. Please complete this pre-test on your phone in order to get CME for your participation in this workshop. You can access the pre-test at:
CME Pre-Test

3. Describe disparities in unintended pregnancy rates in the US.
Explain the tenets of non- judgmental options counseling.
Access resources to integrate medication abortion into primary care practice.
Objectives

4. 6.1 million pregnancies/year in the U.S.
About half (45%) of all pregnancies in the US are unintended.
Mistimed pregnancies refer to women who did not want to become pregnant at the time the pregnancy occurred, but did want to become pregnant at some point in the future.
Unwanted pregnancies refer to women who did not want to become pregnant then or at any time in the future.
The US unintended pregnancy rate is MUCH HIGHER than that of most other developed countries.
Among women who are at risk of an unintended pregnancy, 86% report using a method of contraception.
Nevertheless, almost half of all pregnancies are unintended.
Forty-six percent of women who have unintended pregnancies report using a contraceptive method during the month they became pregnant, although only 5% reported consistent use (41% inconsistent use).
*Data collected looked at experiences of cis-gender women. Does not include data for all birthing people.
Sources:
Finer LB and Zolna MR, Declines in Unintended Pregnancy in the United States, 2008–2011; The New England Journal of Medicine 2016, 374(9):
Singh S, Sedgh G and Hussain R, Unintended pregnancy: worldwide levels, trends and outcomes, Studies in Family Planning, 2010, 41(4):241–250
Guttmacher Institute, 2018 (2011 data)

5. Unintended pregnancy rate by race, ethnicity, and income
Recent trends in unintended pregnancy:
Overall, teen pregnancy in the US has declined over the previous decade.
Poor and less-educated females have higher rates of unintended pregnancy.
The gap between higher-income & poor women’s unintended pregnancy rates has widened steadily since 1981: the rate has slightly increased in poor women (<100% poverty) while it has steadily decreased in low-income and higher-income women ( % poverty and >=200% poverty, resp).
- Women with less access to financial and educational resources may have more difficulty paying for contraception or accessing services to obtain contraception, without which they are at a higher risk of unplanned pregnancies.
Sources:
Finer LB and Zolna MR, Declines in Unintended Pregnancy in the United States, 2008–2011; The New England Journal of Medicine 2016, 374(9):
Frost JJ, Frohwirth LF, Zolna MR. Contraceptive Needs and Services, 2014 Update. Guttmacher Institute, September
Guttmacher Institute. Fact Sheet: Induced Abortion in the United States,
Finer and Zolna, 2016 (2011 data)

6. Outcomes of unintended pregnancies
(Approximately 2.8 million annually)
A woman who has an unintended pregnancy is nearly as likely to carry it to term as to have an abortion.
About four in 10 unintended pregnancies end in abortion.
About 40% of American women will have an abortion at some point in their lives.
Poor and less-educated females were less likely to have induced abortions to end unintended pregnancies. As a result, the income and education disparities in the rate of unintended pregnancies that ended in birth were even greater than the disparities in the unintended pregnancy rate.
Sources:
Guttmacher Institute. Fact Sheet: Induced Abortion in the United States,
Finer LB and Zolna MR, Declines in unintended pregnancy in the United States, 2008–2011, New England Journal of Medicine, 2016, 374(9):843–852
Finer LB and Zolna MR, Shifts in intended and unintended pregnancies in the United States, 2001–2008, American Journal of Public Health, 2014, 104(S1):S44–S48
Guttmacher, 2018 (2014 data)

7. 89% of abortions occur in the first 12 weeks of pregnancy
Almost 90% of abortions are performed in the first trimester.
65% of abortions are performed before nine weeks.
Fewer than 2% of abortions are performed after 20 weeks.
Sources:
Induced Abortion in the United States, Jan 2018 Fact Sheet,
Abortion Incidence and Service Availability in the United States, 2014,
Guttmacher Institute, 2018

8. Abortion access
In 2014, about 90% of US counties had no abortion provider and 39% of women aged lived in those counties. Numbers are essentially stable from In 25 states, more than half of women live in a county without a clinic that provides abortion.
The number of clinics providing abortions declined 6% between 2011 and 2014, and declines were steepest in the Midwest (22%) and the South (13%).
If most primary care clinicians offered medication abortion, the US would no longer have a shortage of abortion providers.
25% of women travel greater than 50 miles to access abortion services
Sources:
Abortion Access in the United States, 2014,
Abortion Incidence and Service Availability in the United States, 2014,
Guttmacher Institute, 2017 (2014 data)

9. Medication & aspiration abortion: both safe and effective
Both medication and aspiration abortion are safe, effective ways to end an early pregnancy.
Success rates with both methods are over 98%
Death rates for both methods are less than 1/100,000, compared to 10/100,000 for continued pregnancy.

10. Safety of abortion First trimester abortions do not increase risk of:
Infertility
Ectopic pregnancy
Miscarriage
Birth defect
Preterm or low-birthweight delivery
Source: National Academies of Sciences, Engineering, and Medicine The Safety and Quality of Abortion Care in the United States. Washington, DC: The National Academies Press.
National Academies of Sciences, Engineering, and Medicine. 2018

11. Medication abortion regimens: three choices
Mifepristone +
Misoprostol
Methotrexate +
Misoprostol
Misoprostol alone
Medical Abortion Regimens:
Mifepristone + misoprostol is the main regimen used currently in the US.
Mifepristone’s high cost limits its use in many countries – and for uninsured/underinsured women in the US.
This presentation focuses mainly on mifepristone/misoprostol abortion.
We will review the 2 other options briefly at the end.

12. The most common regimen in the U.S.
Mifepristone + Misoprostol
The most common regimen in the U.S.

13. Medication abortion: advantages
98-99% effective
Avoids surgical and anesthetic risk
Greater patient autonomy and privacy
Less invasive
More “natural”
Medication abortion advantages:
Highly effective
It’s a treatment employing counseling and medication – NOT a procedure
Offers enhanced privacy/sense of control
Feels more “natural”
May shield abortion providers, staff, & patients from harassment/violence
Expands choice
Easy for new providers to learn

14. Aspiration abortion: advantages
Slightly more effective (99%)
Shorter time to completion
Shorter bleeding duration
Can be performed later in gestation
Aspiration = suction/vacuum/surgical – but does not = D&C
Aspiration abortion advantages:
Highly effective
Shorter time to completion
Shorter bleeding duration
No exposure to possible teratogens
Can be performed until weeks’ gestation

15. Misoprostol Route and Timing
Buccal
Vaginal
Misoprostol dose
800 mcg
Misoprostol timing
hours after Mifepristone
6-72 hours after Mifepristone
Protocol
Gestational age limit
70 days
Mifepristone dose
200 mg oral Taken in office or at home
Office follow-up visit
7-14 days after mifepristone
Minimum office visits
1-2
Cost of medications
$90 for mifepristone; $4 for miso
References for extended gestational limit
Beverly W, Dzuba IG, Chong E, et al. Extending Outpatient Medical Abortion Services Through 70 Days of Gestational Age. Obstetrics & Gynecology. 2012;120(5): doi: /AOG.0b013e31826c315f.
Bracken, H., N.T.N. Ngoc, E. Schaff, K. Coyaji, S. Ambardekar, E. Westheimer, B. Winikoff. Mifepristone Followed in 24 Hours to 48 Hours by Misoprostol for Late First-Trimester Abortion. Obstetrics and Gynecology (Apr 2007), 109 pp
Schaff EA, Fielding SL, Eisinger SH, Stadalius LS, Fuller L. Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days. Contraception. Jan 2000;61(1):41-46.
Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol 2 days after mifepristone 200 mg for abortion up to 63 days of pregnancy. Contraception. Oct 2002;66(4):
References for lower mifepristone dose
Li C-L, Chen D-J, Song L-P, et al. Effectiveness and Safety of Lower Doses of Mifepristone Combined With Misoprostol of the Termination of Ultra-Early Pregnancy: A Dose-Ranging Randomized Controlled Trial. Reproductive Sciences. 2014;22(6):
Weeks AD and Stewart P. The use of low dose mifepristone and vaginal misoprostol for first trimester termination of pregnancy. Br J Fam Planning 1995;21:85-86.
World Health Organization Task Force on Post-Ovulatory Methods of Fertility Regulation. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomized trial. BJOG (4):
Schaff EA, Eisinger SH, Stadalius LS, Franks P, Gore BZ, Poppema S. Low-dose mifepristone 200 mg and vaginal misoprostol for abortion. Contraception. Jan 1999;59(1):1-6.
References for higher misoprostol dose
Coyaji,K., U. Krishna, S. Ambardekar, H. Bracken, V. Raote, A. Mandlekar, B. Winikoff. Are two doses of misoprostol after mifepristone for early abortion better than one? British Journal of Obstetrics and Gynaecology, (Mar 2007), 114 (3), pp. 271–278.
References for non-oral misoprostol route
Schaff EA, et al. Vaginal misoprostol administered at home after mifepristone (RU486) for abortion. J Fam Pract 1997;44:
Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception. Aug 2001;64(2):81-85.
Winikoff B. Oral vs buccal administration of misoprostol after mifepristone for medication abortion up to 63 days. Obstetrics and Gynecology 2008, accepted for publication.
References for misoprostol timing
Guest J, Chien P, Thomson M, Kosseim ML. Randomised controlled trial comparing efficacy of same day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36- to 48-hour protocol. Bjog. Oct 2005;112(10):1457.
Schaff EA, Fielding SL, Westhoff C, et al. Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion: A randomized trial. Jama. Oct ;284(15):
Shannon C., E. Wiebe, F. Jacot, E. Guilbert, S. Dunn, W.R. Sheldon, B. Winikoff. Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial. British Journal of Obstetrics and Gynaecology (Jun 2006), 113(6), pp
Creinin MD, Fox MC, Teal S, Chen A, Schaff EA, Meyn LA: MOD Study Trial Group: A randomized comparison of misoprostol 6 to 8 hours versus 24 hours after mifepristone for abortion. Obstet. Gynecol (5 Pt. 1):

16. Mifepristone Misoprostol Decidual necrosis Cervical ripening
Causes progesterone blockade
Decidual necrosis
Cervical ripening
Detachment
Misoprostol
Causes uterine cramping and expulsion
Mechanism of Mifepristone-induced Abortion:
Mifepristone, an anti-progestin, interferes with early pregnancy by competing with progesterone, causing:
decidual necrosis - edema, dissociation of capillary walls and cytoplasmic lysis of decidual cells; and
cervical ripening - softening and dilation of the cervix.
These effects occur within a few hours after mifepristone administration.
Misoprostol
Prostaglandin: causes cervical softening, uterine contractions, and expulsion of pregnancy
Inexpensive
Made by many companies, available worldwide
Stable at room temperature
Good absorption orally, vaginally, buccally, sublingually
Proven safety record
The only prostaglandin available in the US
References:
Baird D. Mode of action of medical methods of abortion. JAMWA. 2000; 35(3): S
Herrmann WL et al. Effects of the antiprogesterone RU 486 in early pregnancy and during the menstrual cycle. Future aspects in contraception Ch. 22:
Swahn ML, Cekan S, Wang G, Lujndstrom V, Bygdeman M. Pharmacokinetic and clinical studies of RU 486 for fertility regulation. In: Beaulieu EE, Siegel S, eds. The Antiprogestin Steroid RU 486 and Human Fertility Control. New York, NY: Plenum; 1985:

17. Yolanda 22 years old Requests a pregnancy test
Yolanda’s last menstrual period was 6 weeks ago: she’s certain of the date.
Her pregnancy test is positive.
She is married, with a 2-year-old son; she works full-time and will complete college in 1 year; she is not ready to have another child.
She wants the abortion pill.
Photo Source: Ruth Lesnewski

18. Yolanda – counseling issues
Review all options
Ensure the decision is hers
Options counseling is simple for women who are firm in their decision – and it’s more complex for women who are unsure.
Yolanda should know all of her options: parenting, adoption, or medication/aspiration abortion.
Determine that she wants an abortion -- make sure it is Yolanda, not her mother/husband/anyone else, who thinks she should have an abortion.
The role of the clinician is to facilitate the patient’s choice or help them sort it out if they are unsure or conflicted.
Describe medication versus aspiration options.
Assess Yolanda’s home/living situation:
Will she need a support person to help care for her 2-year-old while she is cramping/bleeding?
Is there anyone in Yolanda’s home who may become violent if he/she finds out what is going on?
Photo Source: Ruth Lesnewski
Yolanda – counseling issues

19. Next steps Establish gestational age Rule out contraindications:
Allergy to meds
Chronic adrenal failure
Long-term systemic corticosteroid therapy
Anti-coagulant use (excluding aspirin)
IUD in place
No access to follow-up
Ectopic pregnancy
Indications for sonography
Next steps
Establish gestational age:
Yolanda is certain of her last menstrual period.
Size = dates on bimanual exam.
If any doubts or discrepancy: order or perform a sonogram.
Rule out contraindications:
Any others?
You should also assess the safety of her home environment.
Medication abortion is private, but as it’s happening, it’s hard to keep it a secret from those who live with her.
Indications for sonography:
A sonogram is indicated in the following situations:
Uncertain LMP
If LMP is over 9 weeks
LMP while on hormonal contraception
Irregular menses
Difficult sizing
Size/date discrepancy
Cost of quantitative HCG level (versus cost of sonogram)
Suspected ectopic
Sometimes we do a sonogram for teaching purposes. When we do this, we should let our trainees know – so that they won’t think that sonograms are always needed for medication abortion.
Photo Source: Ruth Lesnewski

20. Yolanda Gestational age: 6 weeks Patient agreement
Yolanda’s clinical exam confirms 6 weeks gestational age.
She is Rh positive.
Her hemoglobin level is 11.4.
Patient agreement:
Yolanda must sign the mifepristone manufacturer's (Danco) patient agreement (which is technically not a consent form).
Then she signs your consent form, including the route & timing for misoprostol.
Sample consent forms are available on the RHAP web site.
Photo Source: Ruth Lesnewski

21. What happens next?
Yolanda takes mifepristone in your office, or later at home
At home, Yolanda takes pain meds, then misoprostol
What happens in your office?
You counsel Yolanda on what to expect.
Yolanda swallows mifepristone in the office or at home. You advise her that she probably won’t have any symptoms until she uses misoprostol at home.
She receives 4 misoprostol tabs (or a prescription for these from a local pharmacy) with instructions for their use at home.
She receives prescriptions for pain medication to take at home (usually ibuprofen 800 mg and a mild narcotic).
She receives prescriptions for hormonal contraception (pill/patch/ring) if desired, so she can start before follow-up visit.
She receives Rho D immune globulin if Rh negative.
She’s instructed about how to reach on-call provider.
She’s given an appointment for follow-up visit in 7-14 days (or info on follow-up by phone).
Before taking misoprostol, she should:
Take ibuprofen
1-5 hours after taking misoprostol, she can expect:
Lots of cramping
Heavy bleeding
Passage of clots and possibly passage of gray tissue
GI upset, fever/chills, headaches
Call if bleeding soaks more than two maxipads/hour for 2 consecutive hours.

22. Follow Up: In office or by phone
7-14 days later
Assure completion
Process experience
Review contraceptive choice
Assess completeness of the abortion:
By history and exam, serial hCG and/or sonogram.
Process experience with the patient.
Review contraceptive choice – insert IUD or implant, inject depot progestin (if she has chosen 1 of these methods); if she has started another method before this visit, ask how that’s going.

23. Phone calls after medication abortion
Was there some bleeding? Any cramping? Did you take the misoprostol?
“There wasn’t much blood.”
Ask if pregnancy symptoms have disappeared.
“Am I still pregnant?”
That’s normal unless you’re soaking two heavy pads an hour for two consecutive hours.
“I’m bleeding and cramping a lot.”
That’s normal unless you’re soaking two heavy pads an hour for two consecutive hours.
Offer follow-up appointment.
“I’m still bleeding after 2 weeks.”
Patients may call with symptoms that worry them. For the vast majority, the only necessary interventions are listening and reassuring.

24. Clostridium sordellii
6 deaths in North America due to toxic shock with Clostridium following medication abortion
Similar deaths, however, also seen following miscarriage, childbirth, trauma, & surgery
CDC: no causal link between medications and these incidents
Clostridium Sordellii causes sepsis and toxic shock syndrome.
It’s quite rare, and nearly always fatal.
It can complicate childbirth, trauma, and GYN surgery (as well as medication abortion)
In the US, this syndrome led Planned Parenthood to change its protocol: PP uses misoprostol buccally rather than vaginally.
We don’t know whether or not this syndrome has anything to do with the route used for misoprostol
Source: CDC 2006, FDA 2006

25. Methotrexate and misoprostol medication abortion
Methotrexate IM + Misoprostol vaginally
In countries where mifepristone is widely available, methotrexate is used infrequently.
Methotrexate is less effective – and the process is longer and less predictable.
Methotrexate can be used only up to 49 days (compared with the 70-day limit for mifepristone).
Methotrexate abortions usually take longer -- may require more visits, additional doses of misoprostol.
However, methotrexate has some advantages:
-It’s inexpensive
-It’s easy to purchase (no special process – can be obtained from a pharmacy)
-It treats early ectopic pregnancy

26. Misoprostol alone medication abortion
800 mcg vaginally
More than one dose might be needed
Misoprostol alone medication abortion
Misoprostol is inexpensive and readily available in most countries.
Misoprostol-only abortion has been studied up to 63 days GA, with efficacy of about 90% - multiple doses often required.
Many women access misoprostol through the “black market,” and may not receive appropriate instructions for use.
After unsupervised misoprostol use, women may present with prolonged and/or heavy bleeding.
However, availability of this method has decreased maternal morbidity and mortality in countries where abortion remains illegal.
Studies of Misoprostol Alone Regimens
Ho PC, Blumenthal PD, Gemzell-Danielsson K, Gómez Ponce de León R, Mittal S, Tang OS. Misoprostol for the termination of pregnancy with a live fetus at 13 to 26 weeks. Int J Gynaecol Obstet Dec;99 Suppl 2:S178-81
Moreno-Ruiz NL, Borgatta L, Yanow S, Kapp N, Wiebe ER, Winikoff B. Alternatives to mifepristone for early medical abortion. Int J Gynaecol Obstet Mar;96(3):212-8
van Bogaert LJ, Sedibe TM. Efficacy of a single misoprostol regimen in the first and second trimester termination of pregnancy. J Obstet Gynaecol Jul;27(5):510-2
Wiebe ER, Trouton KJ, Lima R. Misoprostol alone vs. methotrexate followed by misoprostol for early abortion. Int J Gynaecol Obstet Dec;95(3):286-7
Blanchard K, Shochet T, Coyaji K, Thi Nhu Ngoc N, Winikoff B. Misoprostol alone for early abortion: an evaluation of seven potential regimens. Contraception. Aug 2005;72(2): Blanchard K, Winikoff B, Ellertson C. Misoprostol used alone for the termination of early pregnancy. A review of the evidence. Contraception. Apr 1999;59(4):
Jain JK, Dutton C, Harwood B, Meckstroth KR, Mishell DR, Jr. A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Hum Reprod. Jun 2002;17(6):

27. What barriers do you anticipate if you were to try to provide medication abortions in your office?

28. Conclusion
From pregnancy diagnosis through week nine, medication abortion is safe and effective.
As its success depends on accessibility and counseling, medication abortion is well suited to primary care settings.